Clinical trial NCT02544763
Conditions: Tuberous Sclerosis Complex Seizures
Sponsor: Jazz Pharmaceuticals
Start date: 2016-04-06; Completion date: 2019-02-26
Enrollment: 224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will receive 1 of 2 doses of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a difference between GWP42003-P and placebo in their effect on seizure frequency.

Detailed description:

Arms: arm 1: 100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening). arm 2: 100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening). arm 3: Placebo oral solution matching 100 mg/mL GWP42003-P.
Interventions: intervention 1: GWP42003-P intervention 2: Placebo
Intervention descriptions: intervention 1: Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring. intervention 2: Yellow oily solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.

Protocol documents:
Prot_000.pdf: 
Clinical Study Report GWEP1521 
Version: 23 Dec 19 
Confidential 
V2 21Sep17 
Appendix 1.1 Protocol and Protocol Amendments 
GWEP1521 Clinical Protocol Annex 2 V2 26Apr18  
GWEP1521 Clinical Protocol Annex 2 Am 1 V1 26Apr18 
GWEP1521 Clinical Protocol Annex 1 V3 15Apr19  
GWEP1521 Clinical Protocol Annex 1 Am 2 V1 15Apr19 
GWEP1521 Clinical Protocol Annex 1 Am 1 V1 26Apr18 
GWEP1521 Clinical Protocol V8 23Apr19  
GWEP1521 Clinical Protocol Amendment 7 V1 23Apr19 
GWEP1521 Clinical Protocol Amendment 6 V1 06Sep18 
GWEP1521 Clinical Protocol Amendment 5 V1 07Aug18 
GWEP1521 Clinical Protocol Amendment 4 V1 27Jun17 
GWEP1521 Clinical Protocol Amendment 3 V1 05Dec16 
GWEP1521 Clinical Protocol Amendment 2 V1 25Aug16 
GWEP1521 Clinical Protocol Amendment 1 V1 21Oct15 
GWEP1521 Blinded Phase: NCT02544763
GWEP1521 Open-Label Extension: NCT02544750
Note: These NCT numbers have been applied to the document for purposes of posting on 
clinicaltrials.gov.


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SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol V8 23Apr19 
 
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1 
PROTOCOL SYNOPSIS 
Study Title 
A double-blind, randomized, placebo-controlled study to 
investigate the efficacy and safety of cannabidiol (GWP42003-P, 
CBD) as add-on therapy in patients with tuberous sclerosis 
complex who experience inadequately-controlled seizures. 
Clinical Study 
Type 
Phase 3 
Indication 
Seizures* in patients with tuberous sclerosis complex (TSC). 
*Seizures include: focal motor seizures without impairment of 
consciousness or awareness; focal seizures with impairment of 
consciousness or awareness; focal seizures evolving to bilateral 
generalized convulsive seizures and generalized seizures 
(tonic-clonic, tonic, clonic or atonic) that are countable. 
Primary Objective Blinded Phase: 
To evaluate the efficacy of GWP42003-P as add-on therapy in 
reducing the frequency of seizures when compared with placebo 
in patients with TSC.  
Open-label Extension: 
To evaluate via the adverse events (AE) profile the long term 
safety and tolerability of GWP42003-P as add-on therapy in 
children and adults with TSC who experience 
inadequately-controlled seizures. 
Secondary 
Objectives 
Blinded Phase: 
• To evaluate the effect of GWP42003-P compared with placebo 
on antiepileptic measures. 
• To evaluate the effect of GWP42003-P on growth and 
development (in patients less than 18 years old) compared 
with placebo. 
• To evaluate the effects of GWP42003-P on quality of life 
compared with placebo. 
• To evaluate the safety and tolerability of GWP42003-P 
compared with placebo. 
Open-label Extension: 
• To evaluate the long term effects of GWP42003-P, as add-on 
therapy, on antiepileptic measures. 
• To evaluate the long term effect of GWP42003-P on growth 
and development (in patients less than 18 years old). 
• To evaluate the long term effects of GWP42003-P on quality 
of life. 
• To evaluate the long term safety and tolerability of 


SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
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GWP42003-P. 
Exploratory 
Objectives 
Blinded Phase: 
• To evaluate the effect of GWP42003-P on TSC-associated 
neuropsychiatric disorders (TAND), including cognitive and 
behavioral function and autistic features compared with 
placebo. 
• To determine the pharmacokinetics (PK) of CBD, and its 
major metabolites following single and multiple doses of 
GWP42003-P.  
• To evaluate the effects of GWP42003-P on plasma 
concentrations of concomitant antiepileptic drugs (AEDs), if 
applicable. 
Open-label Extension: 
• To evaluate the long term effect of GWP42003-P on TAND, 
including cognitive and behavioral function and autistic 
features. 
Study Design 
This multicenter study consists of a randomized, 
placebo-controlled, double-blind phase followed by an 
open-label extension (OLE) phase. 
Blinded Phase: 
The blinded phase of the study is a randomized, double-blind, 
parallel-group, 16-week comparison of two doses of 
GWP42003-P versus placebo.  Patients will complete a 1-week 
screening period and a 4-week baseline period before they are 
randomized to receive 25 mg/kg/day GWP42003-P, 50 mg/kg/day 
GWP42003-P or equivalent volumes of placebo.  Randomization 
will be stratified by age according to the following ranges: 1–6,  
7–11, 12–17 years and 18+ years.  Patients will begin a 4-week 
dose escalation period, titrating up to their assigned dose, before 
continuing on a stable dose of blinded investigational medicinal 
product (IMP) for 12 weeks.  
Dose escalation for each patient is subject to the investigator’s 
assessment of safety and tolerability.  If a dose becomes poorly 
tolerated, the investigator may consider temporarily or 
permanently reducing the dose for the remainder of the study. 
Clinic visits will occur for screening (Day −35), baseline 
(Day −28), randomization (Day 1) and, on Days 15 and 29 during 
titration and on Days 43, 57, 71 (telephone) and 85 until the end 
of treatment (Day 113).  Safety telephone calls will be completed 
every two days during titration, one week after the end of titration 
and, for patients not entering the OLE, weekly from Visit 10 to 
Visit 12.  If the call falls on a weekend, it is permitted to schedule 
the call for the Friday before or Monday after the weekend 


SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
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instead. 
Patients will be required to perform daily interactive voice 
response system (IVRS) telephone calls to record seizure 
information.  They will also complete a paper diary daily with 
information about their IMP and concomitant AED 
administration.  
Following completion of the blinded phase, patients will be 
invited to continue to receive GWP42003-P in an OLE.  
Those patients opting not to enter the OLE will complete a 10-day 
taper period (down-titrating 10% per day for 10 days).  
Open-label Extension Transition: 
In order to maintain consistent exposure to IMP and maintain the 
integrity of the blind, patients will enter a 2-week blinded 
transition to the OLE.  OLE IMP will be titrated up to 
25 mg/kg/day whilst blinded IMP is simultaneously tapered down 
to zero.  All patients will complete the transition and enter the 
OLE taking 25 mg/kg/day GWP42003-P:  
• Patients from the placebo group will titrate up to 
25 mg/kg/day GWP42003-P. 
• Patients from the 25 mg/kg/day GWP42003-P group will 
continue to take 25 mg/kg/day GWP42003-P. 
• Patients from the 50 mg/kg/day GWP42003-P group will taper 
down (10% per day) to 25 mg/kg/day GWP42003-P. 
Safety telephone calls will be completed every two days 
throughout the OLE transition.  If the call falls on a weekend, it is 
permitted to schedule the call for the Friday before or Monday 
after the weekend instead. 
Open-label Extension: 
The OLE consists of a 3-week titration period followed by a 
maintenance period and a 10-day taper period.  The initial OLE 
period will last for a maximum of 1 year. 
Following titration according to the titration schedule, patients 
will continue with their optimal GWP42003-P dose.  However, 
investigators may decrease the dose if a patient experiences 
intolerance, or increase the dose to a maximum of 50 mg/kg/day if 
required for better seizure control, until the optimal dose is found.  
Dose increases above 25 mg/kg/day are recommended to be done 
slowly, with maximum increments of 2.5 mg/kg/day every 
two days.  Patients whose dose has been decreased can have their 
dose increased again provided there is adequate tolerance.  Safety 
telephone calls will be completed every two days throughout the 
OLE titration and one week after the end of titration.  If the call 
falls on a weekend, it is permitted to schedule the call for the 


SPONSOR: GW RESEARCH LIMITED 
 
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EudraCT Number: 2015-002154-12 
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Friday before or Monday after the weekend instead.  If seizure 
freedom is achieved with use of GWP42003-P during the study, 
the investigator should consider reducing the dose of concomitant 
AEDs after six months of seizure freedom. 
Primary Endpoint Blinded Phase: 
The primary endpoint is the change in number of TSC-associated 
seizures* during the treatment period (maintenance and titration) 
compared to baseline in patients taking GWP42003-P compared 
with placebo.  
*Primary endpoint TSC-associated seizures include: focal motor 
seizures without impairment of consciousness or awareness; focal 
seizures with impairment of consciousness or awareness; focal 
seizures evolving to bilateral generalized convulsive seizures and 
generalized seizures (tonic–clonic, tonic, clonic or atonic) that are 
countable. 
Open-label Extension: 
The safety of GWP42003-P will be evaluated by assessing the 
incidence, type and severity of AEs. 
Secondary 
Endpoints 
Blinded Phase: 
The following endpoints will be compared between treatment 
groups over the 16-week, double-blind treatment period (all 
changes relative to baseline): 
Key: 
• Number of patients considered treatment responders defined 
as those with a ≥ 50% reduction in TSC-associated seizure 
frequency*.  
• Change in Caregiver Global Impression of Change (CGIC) or 
Subject Global Impression of Change (SGIC) score. 
• Change in total seizures. 
Other: 
Antiepileptic Efficacy Measures: 
• Number of patients considered treatment responders defined 
as those with a ≥ 25%, ≥ 50%, ≥ 75% or 100% reduction in 
TSC-associated seizure* frequency. 
• Number of patients experiencing a > 25% worsening, − 25 to 
+ 25% no change, 25–50% improvement, 50–75% 
improvement or > 75% improvement in TSC-associated 
seizure* frequency. 
• Change in number of TSC-associated seizure*-free days. 
• Change in number of ‘other’ seizures (absence, myoclonic, 


SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
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focal sensory and infantile/epileptic spasms). 
Growth and Development (in patients less than 18 years old): 
• Change in serum insulin-like growth factor-1 (IGF-1) levels. 
• Change in Tanner Staging score (for patients aged 10–17 
[inclusive]). 
Quality of Life: 
• Changes in the Quality of Life in Childhood Epilepsy 
(QOLCE; patients 2–18 years) or Quality of Life in Epilepsy 
(QOLIE-31-P; patients 19+ years) score. 
• Change in Physician Global Impression of Change (PGIC) 
score. 
Safety and Tolerability: 
• AEs. 
• Clinical laboratory parameters. 
• 12-lead electrocardiogram (ECG). 
• Physical examination parameters (including height and 
weight). 
• Vital signs. 
• Columbia-Suicide Severity Rating Scale (C-SSRS; 19+ years) 
or C-SSRS Children’s (6–18 years) score, where applicable.  
• Number of inpatient hospitalizations due to epilepsy. 
• Abuse liability. 
• Effects on menstruation cycles (in females). 
Open-label Extension: 
The following endpoints will be assessed relative to the 
pre-randomization baseline of the blinded phase: 
Antiepileptic Efficacy Measures: 
*TSC-associated seizures include: focal motor seizures without 
impairment of consciousness or awareness; focal seizures with 
impairment of consciousness or awareness; focal seizures 
evolving to bilateral generalized convulsive seizures and 
generalized seizures (tonic–clonic, tonic, clonic or atonic) that are 
countable. 
Key: 
• Percentage change in number of TSC-associated seizures* 
(average per 28 days).  
• Number of patients considered treatment responders defined 
as those with a ≥ 50% reduction in TSC-associated seizure 
frequency*.  


SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol V8 23Apr19 
 
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• Change in CGIC or SGIC score. 
• Change in total seizures. 
Other: 
• Number of patients considered treatment responders defined 
as those with a ≥ 25%, ≥ 50%, ≥ 75% or 100% reduction in 
TSC-associated seizure* frequency. 
• Number of patients experiencing a > 25% worsening, − 25 to 
+ 25% no change, 25–50% improvement, 50–75% 
improvement or > 75% improvement in TSC-associated 
seizure* frequency. 
• Change in number of TSC-associated seizure*-free days. 
• Change in number of ‘other’ seizures (absence, myoclonic, 
focal sensory and infantile/epileptic spasms). 
Growth and Development (patients less than 18 years): 
• Change in serum IGF-1 levels. 
• Change in Tanner Staging score (for patients aged 10–17 
[inclusive]). 
Quality of Life: 
• Changes from baseline in the QOLCE (patients 2–18 years) or 
QOLIE-31-P (patients 19+ years) score. 
• Change in PGIC score. 
Safety and Tolerability: 
• Clinical laboratory parameters. 
• ECG. 
• Physical examination parameters (including height and 
weight). 
• Vital signs. 
• C-SSRS (19+ years) or C-SSRS Children’s (6–18 years) score, 
where applicable.  
• Number of inpatient hospitalizations due to epilepsy. 
• Abuse liability. 
• Effects on menstruation cycles (in females). 
Exploratory 
Endpoints 
Double-blind and Open-label Extension: 
Antiepileptic Efficacy Measures: 
• Change in composite focal seizure score 
(frequency × severity). 
• Change in number of seizures by subtype. 
• Change in use of rescue medication. 


SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
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• Change in the number of episodes of status epilepticus 
(convulsive and non-convulsive). 
• Changes in duration of seizure subtypes as assessed by the 
Subject Global Impression of Change in Seizure Duration 
(SGIC-SD) or the Caregiver Global Impression of Change in 
Seizure Duration (CGIC-SD). 
TAND: 
Cognitive and Behavioral Function: 
• Changes in Vineland Adaptive Behavior Scales, Second 
Edition (Vineland-II). 
• Changes in Wechsler Scales (pre-school, primary, children, 
adult). 
• Changes in Achenbach Child Behavior Checklist (CBCL) and 
Adult Behavior Checklist (ABCL). 
Autistic Features: 
• Change in Social Communication Questionnaire (SCQ) score. 
PK (Double-blind only): 
• The plasma concentrations will be summarized by time 
window for CBD and its major metabolites following single 
and multiple doses of GWP42003-P.  Where data allows, the 
area under the plasma concentration curve (AUC0–t) from time 
zero to the last measurable time-point will be calculated. 
• Plasma concentrations of concomitant AEDs before and after 
treatment with GWP42003-P, where available. 
Sample Size 
Blinded Phase: 
A total of 210 patients will be targeted to be enrolled.  The 
210 patients will be randomly allocated to one of four treatment 
groups (GWP42003-P 25 mg/kg/day, GWP42003-P 
50 mg/kg/day, placebo 25 mg/kg/day dose volume equivalent, or 
placebo 50 mg/kg/day dose volume equivalent) at a 2:2:1:1 ratio.  
The placebo groups will be pooled for the analyses of efficacy.   
If it is assumed that patients in the placebo group will experience a 
mean reduction in seizure frequency of 15% (from baseline), 
patients receiving GWP42003-P will experience at least a 50% 
reduction in seizures and a common standard deviation of 60%, 
then this sample size of 70 patients per group will be sufficient to 
detect a difference in response distributions with 90% power.  
This test is based on a two-sided non-parametric 
Mann-Whitney-Wilcoxon test for continuous response data with a 
5% significance level. 
Open-label Extension: 
All patients who wish to continue on IMP following completion 


SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
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of the blinded phase. 
Summary of 
Patient 
Eligibility Criteria 
Inclusion: Patients meeting the following criteria will be 
considered eligible for this study: 
• Patient is male or female aged between one and 65 years 
inclusive. 
• Patient and/or parent(s)/legal representative is willing and able 
to give informed consent/assent for participation in the study. 
• Patient and their caregiver are willing and able (in the 
investigator’s opinion) to comply with all study requirements 
(including accurate diary and IVRS completion). 
• Well-documented clinical history of epilepsy, which is not 
completely controlled by their current AEDs.  
• Clinical diagnosis of TSC according to criteria agreed by the 
2012 International Tuberous Sclerosis Complex Consensus 
Conference. 
• Taking one or more AEDs at a dose which has been stable for 
at least four weeks prior to screening. 
• All medications or interventions for epilepsy (including 
ketogenic diet and any neurostimulation devices for epilepsy) 
must have been stable for one month prior to screening and the 
patient is willing to maintain a stable regimen throughout the 
study. 
• Patient is willing to keep any factors expected to affect 
seizures stable (such as the level of alcohol consumption and 
smoking). 
• Patient and/or parent(s)/legal representative is willing to allow 
the responsible authorities to be notified of participation in the 
study, if mandated by local law. 
• Patient and/or parent(s)/legal representative is willing to allow 
his or her primary care practitioner and consultant (if they 
have one) to be notified of participation in the study, if 
mandated by local law. 
At the end of the baseline period patients must also meet the 
following criteria: 
• Experienced at least eight seizures during the first 28 days of 
the baseline period with at least one seizure occurring in at 
least three of the four weeks (seizures include: focal motor 
seizures without impairment of consciousness or awareness; 
focal seizures with impairment of consciousness or awareness; 
focal seizures evolving to bilateral generalized convulsive 
seizures and generalized seizures [tonic–clonic, tonic, clonic 
or atonic]) that are countable. 


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• Completed at least 90% of calls to IVRS during the first 
28 days of the baseline period (a minimum of 25 completed 
calls).  
Exclusion: The patient may not enter the study if ANY of the 
following apply: 
• Patient has a history of pseudo-seizures. 
• Patient has clinically significant unstable medical conditions 
other than epilepsy. 
• Patient has an illness in the four weeks prior to screening or 
randomization, other than epilepsy, which in the opinion of the 
investigator could affect seizure frequency. 
• Patient has undergone general anesthetic in the four weeks 
prior to screening or randomization. 
• Patient has undergone surgery for epilepsy in the six months 
prior to screening. 
• Patient is being considered for epilepsy surgery or any 
procedure involving general anesthesia during the blinded 
phase of the study. 
• Patient has been taking felbamate for less than one year prior 
to screening. 
• Patient is taking an oral mammalian target of rapamycin 
(mTOR) inhibitor. 
• Patient has, in the investigator’s opinion, clinically 
significantly abnormal laboratory values. 
• Patient has any known or suspected hypersensitivity to 
cannabinoids or any of the excipients of the IMP, such as 
sesame oil.  
• Any history of suicidal behavior or any suicidal ideation of 
type 4 or 5 on the C-SSRS in the last month or at screening. 
• Patient is currently using or has in the past used recreational or 
medicinal cannabis, or cannabinoid-based medications, within 
the three months prior to screening and is unwilling to abstain 
for the duration for the study. 
• Patient has tumor growth which, in the opinion of the 
investigator, could affect the primary endpoint. 
• In the opinion of the investigator the patient has clinically 
significant abnormalities in the ECG measured at screening or 
randomization or any concurrent cardiovascular conditions, 
which will interfere with the ability to read their ECGs.  
• Patient has significantly impaired hepatic function at the 
screening visit (Visit 1) or the randomization visit (Visit 3), 


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defined as any of the following: 
− Serum alanine aminotransferase (ALT) or aspartate 
aminotransferase (AST) > 5 × upper limit of normal 
(ULN). 
− TBL* [serum total bilirubin] ≥ 2 × ULN or international 
normalized ratio [INR] > 1.5 (*TBL ≥ 2 × ULN exclusion 
will not apply for patients diagnosed with Gilbert’s 
disease). 
− Serum ALT or AST ≥ 3 × ULN with the presence of 
fatigue, nausea, vomiting, right upper quadrant pain or 
tenderness, fever, rash, and/or eosinophilia (> 5%). 
This criterion can only be confirmed once the laboratory 
results are available.  
• Patient is female and of childbearing potential, or is male 
whose partner is of child bearing potential, unless willing to 
ensure that they or their partner use a highly effective method 
of birth control (e.g., hormonal contraceptives, intrauterine 
devices/hormone-releasing systems, bilateral tubal occlusion, 
vasectomized partner, sexual abstinence) during the study and 
for three months thereafter. 
• Female patient who is pregnant (positive pregnancy test), 
lactating or planning pregnancy during the course of the study 
and for three months thereafter. 
• Patient has received an IMP less than 12 weeks prior to the 
screening visit. 
• Patient has any other significant disease or disorder which, in 
the opinion of the investigator, may either put the patient at 
risk because of participation in the study, may influence the 
result of the study, or may affect the patient’s ability to take 
part in the study. 
• Any abnormalities identified following a physical examination 
of the patient that, in the opinion of the investigator, would 
jeopardize the safety of the patient if they take part in the 
study. 
• Patient has donated blood during the past 12 weeks and is 
unwilling to abstain from donation of blood during the study. 
• Patient has been previously randomized into this study. 
• Patient has any known or suspected history of alcohol or 
substance abuse.  
• Patient has travel outside the country and/or state of residence 
planned during the trial, unless the patient has confirmation 
that the IMP is permitted in the destination country/state. 


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Criteria for 
Withdrawal 
The patient must be withdrawn from the study if any of the 
following apply: 
• Administrative decision by the investigator, GW or regulatory 
authority. 
• Pregnancy. 
• Protocol deviation that is considered to potentially 
compromise the safety of the patient. 
• Withdrawal of patient consent/assent. 
• Withdrawal of parent(s)/legal representative consent. 
• ALT or AST > 3 × ULN with the appearance of fatigue, 
nausea, vomiting, right upper quadrant pain or tenderness, 
fever, rash, and/or eosinophilia (> 5%). 
• ALT or AST > 8 × ULN. 
• ALT or AST > 5 × ULN for more than two weeks. 
• ALT or AST > 3 × ULN and (TBL > 2 × ULN or INR > 1.5). 
• Lost to follow-up. 
Note: Prior to withdrawal for the transaminase elevations 
noted above, the investigator may choose to confirm the 
transaminase elevations by repeating the following laboratory 
tests within 24 to 48 hours: ALT, AST, TBL, INR, % 
eosinophils, gamma-glutamyl transferase and alkaline 
phosphatase.  Should the above transaminase elevation 
criteria be confirmed, the patient must be withdrawn from the 
trial. 
The patient may also be withdrawn from the study for any of the 
following: 
• Did not meet eligibility criteria. 
• Patient non-compliance. 
• AE (including clinically significant laboratory result) which, 
in the opinion of the investigator, would compromise the 
continued safe participation of the patient in the study. 
• Suicidal ideation or behavior of type 4 or 5 during the 
treatment period, as evaluated with the C-SSRS. 
• Any evidence of drug abuse or diversion. 
• General anesthesia (blinded phase only). 
• Addition of a new AED (blinded phase only). 
Investigational 
Medicinal 
Product: 
Formulation, 
GWP42003-P solution (100 mg/mL cannabidiol in sesame oil 
with anhydrous ethanol, sweetener [sucralose] and strawberry 
flavoring). 
Placebo solution (sesame oil) containing the excipients anhydrous 


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Mode of 
Administration, 
Dose and 
Regimen 
ethanol, sweetener (sucralose) and strawberry flavoring. 
Blinded Phase: 
Patients will titrate the IMP up to the required dose over 
four weeks as per randomization.  Patients will then remain at this 
maintenance dose for 12 weeks.  
Dose escalation for each patient is subject to the investigator’s 
assessment of safety and tolerability.  If a dose becomes poorly 
tolerated, the investigator may consider temporarily or 
permanently reducing the dose for the remainder of the study.  
Patients will be on treatment for a total of 16 weeks.  
Patients not entering the OLE or who withdraw early will 
down-titrate over a period of 10 days.  Patients who decide to 
enter the open-label extension will enter the Open-label Extension 
Transition. 
Titration from 0–25 mg/kg/day will begin at 5 mg/kg/day and will 
be increased in increments of 5 mg/kg/day every two days 
(patients will remain on each dose level for two days before they 
progress on to the next dose). 
Titration from 25–50 mg/kg/day will continue at smaller 
increments of 2.5 mg/kg/day every two days. 
IMP will be taken twice daily (morning and evening). 
Open-label Extension Transition: 
This double-blind transition phase will take two weeks to 
complete.  OLE IMP will be titrated up to 25 mg/kg/day whilst 
blinded IMP is simultaneously tapered down to zero.  All patients 
will complete the transition and enter the OLE taking 
25 mg/kg/day GWP42003-P:  
• Patients from the placebo group will titrate up to 
25 mg/kg/day. 
• Patients from the 25 mg/kg/day group will continue to take 
25 mg/kg/day. 
• Patients from the 50 mg/kg/day will taper down (10% per day 
for 5 days) to 25 mg/kg/day. 
Open-label Extension: 
Patients may titrate the IMP up to the target dose of 50 mg/kg/day. 
Patients will then remain at this dose until the ‘End of Treatment’ 
visit, with the option for doses to be increased or decreased if 
deemed necessary by the investigator, to a maximum of 
50 mg/kg/day.  Following the ‘End of Treatment’ visit or decision 
to withdraw, doses of the IMP will be tapered down (10% per day 
for 10 days) at home until the ‘End of Taper’ visit.  IMP will be 
taken twice daily (morning and evening). 
In the UK, enrollment of patients between the ages of 12 and 


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23 months will only commence once 15 patients over the age of 
23 months have been dosed for a minimum of 4 weeks and no 
new safety issues have been observed.  
Control Group 
The control group will receive equal volumes of matching 
placebo. 
Procedures 
Screening Assessments (Blinded Phase) Will Include: 
• Informed consent/assent 
• Demographic assessment 
• Full medical history (including seizure information since 
diagnosis and all prior AEDs taken) 
• Concomitant medication review (including AEDs) 
• Physical examination 
• Vital signs assessment 
• Postural blood pressure 
• Clinical laboratory samples (blood and urine) will be taken 
for: 
− Hematology 
− Biochemistry 
− Urinalysis 
− Urine/serum THC screen 
− Urine/serum pregnancy tests (if appropriate) 
− TSC1 and TSC2 mutation status (if not known previously) 
if the patient/parent(s)/legal representative provide consent 
• ECG 
• Suicidality 
Patients who satisfy all inclusion and none of the exclusion 
criteria will be assigned a unique patient number. 
After the screening visit, investigators will submit the patient’s 
documented history of seizures directly to the Epilepsy Study 
Consortium (ESC) for verification of seizure types.  The ESC may 
ask the investigator for additional information to assist in their 
decision.  The ESC will provide written confirmation directly to 
the investigator. 
Baseline Visit: 
Following written confirmation of seizure classification from the 
ESC patients will attend a Baseline Visit before beginning the 
28-day baseline observation period.  The patient’s attendance is 
preferred, but if this is not possible the primary caregiver can 
attend alone provided that this caregiver (not the patient) will be 
responsible for seizure identification, IVRS use, and paper diary 


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completion.  The following assessments will be completed: 
• Concomitant medication review (including AEDs) 
• AE review 
• Epilepsy-related hospitalizations review 
• IVRS training 
• Patient diary issue and training 
The investigator will review and train the patient or their caregiver 
to identify the patient’s expected seizure types.  Patients or their 
caregivers will make a daily IVRS call to record daily seizure 
information including all seizures and episodes of status 
epilepticus.  Patients or their caregivers will be given a paper diary 
to record usage of IMP, rescue medication, concomitant AEDs, 
and AEs and will be instructed on how to do so. 
Randomization Visit Assessments: 
Following the 28-day baseline observation period the investigator 
will assess the patient’s daily number of seizures from IVRS data. 
Patients who continue to satisfy all inclusion and none of the 
exclusion criteria will be randomized.  Patients will then receive 
sufficient IMP, as assigned by IVRS, every 14 to 28 days for the 
16-week treatment period.  Before taking their first dose of IMP in 
clinic the following assessments will be completed: 
• Concomitant medication review (including AEDs) 
• AE review 
• Epilepsy-related hospitalizations review 
• Physical examination  
• Tanner Staging (where appropriate) 
• Details of menstruation (for females) 
• ECG (including pre-dose baseline and +4 hours [±30 minutes] 
after first dose) 
• Vital signs 
• Postural blood pressure 
• Suicidality 
• SGIC-SD or CGIC-SD 
• Vineland-II 
• Wechsler Tests 
• CBCL or ABCL 
• SCQ 
• QOLCE or QOLIE-31-P 
• CGIC or SGIC 
• PGIC 


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• Clinical laboratory samples (blood and urine) will be taken 
for: 
− Hematology 
− Biochemistry 
− Urinalysis 
− Urine/serum pregnancy tests (if appropriate) 
− Serum IGF-1 
− PK (patients > 20 kg only) 
− AED concentrations 
• Review of IVRS and patient diary 
• IMP dispensing 
Post Randomization Assessments: 
Clinic visits will occur on Day 15, Day 29, Day 43, Day 57, Day 
85 and Day 113 with a telephone visit occurring on Day 71. 
Additional safety telephone calls will be completed every two 
days during titration and one week after the end of titration.  If the 
call falls on a weekend, it is permitted to schedule the call for the 
Friday before or the Monday after the weekend instead. 
The following assessments will be completed at every clinic visit 
except where indicated:  
• Concomitant medication review (including AEDs) 
• AE review 
• Epilepsy-related hospitalizations review 
• Physical examination  
• Tanner Staging, where appropriate (Visit 10) 
• Details of menstruation (for females) (Visit 10) 
• ECG  
• Vital signs 
• Postural BP (Visit 5) 
• Suicidality 
• SGIC-SD or CGIC-SD (Visit 10) 
• Vineland-II (Visit 10) 
• Wechsler Tests (Visit 10) 
• CBCL or ABCL (Visit 10) 
• SCQ (Visit 10) 
• QOLCE or QOLIE-31-P (Visit 10) 
• CGIC or SGIC (Visit 10) 
• PGIC (Visit 10) 
• Clinical laboratory samples (blood and urine) will be taken 


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for: 
− Hematology 
− Biochemistry 
− Urinalysis 
− Urine/serum pregnancy tests (Visits 5, 7, 9 and 10, if 
appropriate) 
− Serum IGF-1 (Visit 10) 
− PK (Visit 10; patients > 20 kg only) 
− AED concentrations (Visits 5, 7, 9 and 10) 
• Review of patient diary 
• IMP dispensing, collection and compliance review 
PK: 
Blood sample collection for PK analysis of CBD and its major 
metabolites will be taken at Visits 3 and 10 for patients weighing 
more than 20 kg.  Where appropriate, blood samples will be taken 
as follows: 
• One sample pre-dose (i.e., prior to administration of IMP). 
• One sample between 2 and 3 hours post-dose. 
• One sample between 4 and 6 hours post-dose.  
• One sample between 8 and 10 hours post-dose (patients 
18 years and above only). 
Blood samples will be collected for analysis of plasma 
concentrations of concomitant AEDs (if possible) ideally at the 
following time points: 
• Visit 3 - Pre-IMP-dose. 
• Visit 5 - Pre-IMP-dose. 
• Visit 7 - Pre-IMP-dose. 
• Visit 9 - Pre-IMP-dose. 
• Visit 10 - Pre-IMP-dose. 
Additional blood samples may be taken for AED monitoring if 
there is a suspicion of changes in AED levels, with the aim to 
keep the AED plasma levels within the patient’s therapeutic level. 
Open-label Extension Transition and Open-label Extension: 
Following completion of the blinded phase of the study, patients 
will enter a 2-week blinded transition followed by a 3-week 
titration.  Safety telephone calls will be conducted every two days 
during this 5-week period and one week after the end of titration. 
If the call falls on a weekend, it is permitted to schedule the call 
for the Friday before or Monday after the weekend instead.  OLE 
visits will occur on Day 15, Day 36, Day 92 and then every 
13 weeks up to 1 year.  Additional IMP Re-supply Visits will be 


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scheduled between Assessment Visits. 
The following assessments will be completed at all visits during 
the OLE, except where indicated (full listing by visit included in 
Section 9.1.2): 
• Concomitant medication review (including AEDs) 
• AE review 
• Review of patient diary 
• IMP dispensing, collection and compliance review 
• Physical examination  
• Tanner Staging, where appropriate (Visit B10) 
• ECG  
• Vital signs  
• Suicidality 
• SGIC-SD or CGIC-SD (Visits B4, B6, B8 and B10) 
• Vineland-II (Visits B6 and B10) 
• Wechsler Tests (Visits B6 and B10) 
• CBCL or ABCL (Visits B6 and B10) 
• SCQ (Visits B6 and B10) 
• QOLCE or QOLIE-31-P (Visits B6 and B10) 
• CGIC or SGIC (Visits B6 and B10) 
• PGIC (Visits B6 and B10) 
• Clinical laboratory samples (blood and urine) will be taken 
for: 
− Hematology  
− Biochemistry  
− Urinalysis  
− Urine/serum pregnancy tests (Visits B4, B6, B8 and B10, 
if appropriate) 
− Serum IGF-1 (Visits B6 and B10) 
− AED concentrations  
Additional re-supply visits are scheduled during the OLE and will 
include a review of concomitant medications (including AEDs), 
AEs, patient diary and IMP dispensing, collection and compliance 
review. 
Monitoring of Drug Abuse Liability (for Patients 12 Years of 
Age and Older): 
During the routine collection of AEs in this study, if AEs are 
reported which can illuminate an abuse potential signal, then the 
investigator or study coordinator is required to complete an 


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additional Supplemental Adverse Event Form and Site 
Classification Form (investigator only) following further 
discussion of the event(s) with the patient/caregiver.  
The second trigger that will require the investigator or study 
coordinator to discuss abuse potential signals with the 
patient/caregiver is drug accountability issues regarding overuse 
of the IMP or missing bottles.  
Irrespective of the above, all patients/caregivers will be 
interviewed at their final dosing visit of the blinded phase 
(Visit 10 or 11) and again at their final dosing visit of the OLE 
(Visit B10 or B11).  A Study Medication Use and Behavior 
Survey will be completed by the investigator or study coordinator.  
A formal Adjudication Committee will be appointed and assigned 
to this initiative to classify triggered cases.  The Adjudication 
Committee will meet on a periodic basis to review and assess all 
of the information collected on triggered cases. 
Statistical 
Considerations 
Blinded Phase: 
Each of the primary and secondary endpoints will be described 
and compared between treatment groups, using appropriate 
statistical methods, over the 16-week, double-blind maintenance 
and titration period. 
Statistical hypothesis testing will be performed on the primary 
endpoint and other endpoints as appropriate.  Each endpoint, 
including the primary will have 2 comparisons against placebo 
(25 mg/kg/day GWP42003-P and 50 mg/kg/day GWP42003-P vs. 
placebo).  Also, 3 key secondary endpoints have been defined. 
The primary and key secondary endpoints will be tested with their 
Type I error controlled by use of a hierarchical gate-keeping 
procedure.  One must reject the null hypothesis of an endpoint at 
the level of 0.05 (2-sided) to test the hypothesis of the subsequent 
endpoint in the sequence at the level of 0.05 (2-sided).  If a null 
hypothesis is not rejected then testing will stop and all subsequent 
analyses will be declared not statistically significant. 
The secondary endpoints will be tested hierarchically, starting 
with the key secondary endpoints followed by all other and 
exploratory secondary endpoints.  No multiplicity adjustments 
will be made for all other secondary endpoints. 
All other statistical tests will be two-tailed and carried out at the 
5% level of significance. 
All safety data will be summarized using appropriate statistical 
methods. 
Open-label Extension: 
All data collected during this study will be summarized across 


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time, using appropriate statistical methods.  Where baseline data 
are available from the blinded phase, changes from baseline will 
also be presented.  
Descriptive statistical methods will be used throughout.  There 
will be no formal hypothesis testing. 
Sponsor 
GW Research Ltd 
Sovereign House 
Vision Park 
Chivers Way 
Histon 
Cambridge CB24 9BZ 
United Kingdom 
 


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SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
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Protocol V8 23Apr19 
 
Confidential 
Page 23 of 154 
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# Safety telephone calls must be completed every two days during titration and one week after the end of titration.  If the call falls on a weekend, it is permitted to schedule 
the call for the Friday before or Monday after the weekend instead. 
Figure 1-2 
Study Design and Treatment Schema: Open-label Extension 
Visit B1
Day 1
Visit B2
Day 15 
(±3 days)
Visit B3 
Day 36 
(± 3 days)
Follow-up
Visit**
(+ 3 days)
End of 
Taper Visit#
(+ 3 days)
End of 
Treatment Visit
Day 365 
Visit B4 
Day 92 
(± 3 days)
Visit B6 
Day 183 
(± 7 days)
Visit B8 
Day 274 
(± 7 days)
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 Period
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8 weeks
13 weeks
13 weeks
13 weeks
10 days
4 weeks
Titration 
Period 
†† 
B5Δ 
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B7Δ
Day 232 
B9Δ
Day 323 
 
* To avoid double-dosing of IMP at Visit 1, patients will be instructed to begin titration of IMP the following day, which will be regarded as Day 1. As such, Visit 1 will 
occur on Day −1 with no clinic visit on Day 1. 
# Following the ‘End of Taper Period’ visit, a safety telephone call must be made two weeks later to collect seizure information, and to assess AEs, epilepsy-related 
hospitalizations, concomitant medications and/or changes to medication. 
** Can be conducted by telephone. 


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ΔB5, B7 and B9 – Re-supply visits. 
†† Safety telephone calls must be completed every two days during blinded transition, titration and one week after the end of titration.  If the call falls on a weekend, it is 
permitted to schedule the call for the Friday before or Monday after the weekend instead.


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Table of Contents 
Title Page ................................................................................................... 1 
1 
PROTOCOL SYNOPSIS ................................................................ 3 
Table of Contents .................................................................................... 25 
List of Appendices................................................................................... 31 
List of In-text Tables .............................................................................. 32 
List of In-text Figures ............................................................................. 33 
List of Abbreviations .............................................................................. 34 
Definition of Terms ................................................................................. 37 
2 
OBJECTIVES ................................................................................ 38 
2.1 
Primary ........................................................................................................ 38 
2.2 
Secondary .................................................................................................... 38 
2.3 
Exploratory .................................................................................................. 39 
3 
BACKGROUND AND RATIONALE ......................................... 40 
3.1 
Disease......................................................................................................... 40 
3.2 
GWP42003-P Background .......................................................................... 43 
3.3 
Rationale ...................................................................................................... 44 
3.3.1 
Selection of Study Dose ............................................................................ 44 
3.4 
Clinical Hypothesis ..................................................................................... 46 
4 
EXPERIMENTAL PLAN ............................................................. 47 
4.1 
Study Design ............................................................................................... 47 
4.1.1 
Primary Endpoint ...................................................................................... 48 
4.1.2 
Secondary Endpoint(s) .............................................................................. 49 
4.2 
Number of Centers ...................................................................................... 53 
4.3 
Number of Patients ...................................................................................... 53 
5 
INVESTIGATIONAL MEDICINAL PRODUCT ..................... 54 
5.1 
GWP42003-P Solution ................................................................................ 54 
5.2 
Placebo Solution .......................................................................................... 54 
5.3 
Packaging, Storage and Drug Accountability ............................................. 54 
5.3.1 
Packaging and Labeling ............................................................................ 54 
5.3.2 
Storage ...................................................................................................... 55 


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5.3.3 
Supply and Return of Investigational Medicinal Product ......................... 56 
5.3.4 
Investigational Medicinal Product Accountability ................................... 56 
6 
PATIENT ELIGIBILITY ............................................................. 58 
6.1 
Inclusion Criteria ......................................................................................... 58 
6.2 
Exclusion Criteria ........................................................................................ 59 
7 
PATIENT ENROLLMENT ......................................................... 62 
7.1 
Treatment Assignment ................................................................................ 62 
7.2 
Randomization............................................................................................. 62 
8 
TREATMENT PROCEDURES ................................................... 63 
8.1 
Investigational Medicinal Product Dosage, Administration and 
Schedule ...................................................................................................... 63 
8.1.1 
Dose Administration ................................................................................. 63 
8.1.2 
Dose Escalation and Dose Adjustments ................................................... 63 
8.2 
Concomitant Therapy .................................................................................. 66 
8.3 
Prohibited Therapy During Study Period .................................................... 67 
8.4 
Compliance in Investigational Medicinal Product Administration ............. 67 
8.5 
Access to Blinded Treatment Assignment (Blinded Phase and OLE 
Transition Only) .......................................................................................... 68 
9 
STUDY PROCEDURES ............................................................... 69 
9.1 
Study Procedures by Visit ........................................................................... 69 
9.1.1 
Blinded Phase ........................................................................................... 69 
9.1.1.1 
Visit 1 (Day −35, Screening) ................................................................ 69 
9.1.1.2 
Visit 2 (Day −28, Baseline) ................................................................... 70 
9.1.1.3 
Visit 3 (Day 1, Randomization) ............................................................ 70 
9.1.1.4 
Visit 4 (Day 15) ..................................................................................... 72 
9.1.1.5 
Visit 5 (Day 29) ..................................................................................... 72 
9.1.1.6 
Visit 6 (Day 43) ..................................................................................... 73 
9.1.1.7 
Visit 7 (Day 57) ..................................................................................... 73 
9.1.1.8 
Visit 8 (Day 71) ..................................................................................... 74 
9.1.1.9 
Visit 9 (Day 85) ..................................................................................... 74 
9.1.1.10 
Visit 10 (Day 113, End of Treatment/Withdrawal Visit) ...................... 75 
9.1.1.11 
Visit 11 (Day 123, End of Taper) ......................................................... 76 


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9.1.1.12 
Visit 12 (Day 151, Safety Follow-up) ................................................... 77 
9.1.2 
Open-label Extension ................................................................................ 77 
9.1.2.1 
Visit B1 (Day 1) .................................................................................... 77 
9.1.2.2 
Visit B2 (Day 15) .................................................................................. 79 
9.1.2.3 
Visit B3 (Day 36) .................................................................................. 79 
9.1.2.4 
Visit B4 (Day 92) .................................................................................. 80 
9.1.2.5 
Visit B5 (Day 141, Re-supply Visit) ..................................................... 81 
9.1.2.6 
Visit B6 (Day 183) ................................................................................ 81 
9.1.2.7 
Visit B7 (Day 232, Re-supply Visit) ..................................................... 82 
9.1.2.8 
Visit B8 (Day 274) ................................................................................ 82 
9.1.2.9 
Visit B9 (Day 323, Re-supply Visit) ..................................................... 83 
9.1.2.10 
Visit B10 (Day 365, End of Treatment/Withdrawal Visit) ................... 84 
9.1.2.11 
Visit B11 (Day 375, End of Taper Period Visit) ................................... 85 
9.1.2.12 
B12 (Day 389, Post-taper Safety Telephone Call) ................................ 85 
9.1.2.13 
Follow-up Visit ..................................................................................... 86 
9.1.2.14 
Safety Telephone Calls ......................................................................... 86 
9.2 
Study Procedure Listing .............................................................................. 86 
9.2.1 
Informed Consent/Assent ......................................................................... 86 
9.2.2 
Contraception Requirements .................................................................... 87 
9.2.3 
Demographics ........................................................................................... 88 
9.2.4 
Medical History ........................................................................................ 88 
9.2.5 
Concomitant Medication .......................................................................... 88 
9.2.6 
Physical Examination ............................................................................... 88 
9.2.7 
Vital Signs and Blood Pressure ................................................................ 88 
9.2.8 
12-Lead Electrocardiogram ...................................................................... 89 
9.2.9 
Clinical Laboratory Sampling................................................................... 89 
9.2.9.1 
Pharmacokinetic Blood Sampling ......................................................... 91 
9.2.9.2 
Determination of Plasma Concentrations of Concomitant 
Antiepileptic Drugs ............................................................................... 92 
9.2.9.3 
Determination of Mutation Status of the TSC1 and TSC2 Genes ......... 92 
9.2.10 
Interactive Voice Response System .......................................................... 92 
9.2.11 
Patient Diary ............................................................................................. 93 
9.2.12 
Questionnaires and Assessments Completed at Scheduled Visits ............ 94 


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9.2.12.1 
Subject/Caregiver Global Impression of Change .................................. 94 
9.2.12.2 
Physician Global Impression of Change ............................................... 95 
9.2.12.3 
Subject/Caregiver Global Impression of Change in Seizure 
Duration................................................................................................. 95 
9.2.12.4 
Quality of Life in Childhood Epilepsy (18 Years of Age and 
Younger) or Quality of Life in Epilepsy (19 Years of Age and 
Older) .................................................................................................... 96 
9.2.12.5 
Vineland Adaptive Behavior Scales, Second Edition ........................... 96 
9.2.12.6 
Child/Adult Behavior Checklist ............................................................ 96 
9.2.12.7 
Social Communication Questionnaire .................................................. 96 
9.2.12.8 
Suicidality/ Children’s/Columbia-Suicide Severity Rating Scale 
(Six Years of Age and Older)................................................................ 97 
9.2.12.9 
Wechsler Tests ...................................................................................... 97 
9.2.13 
Menstruation ............................................................................................. 98 
9.2.14 
Tanner Staging .......................................................................................... 98 
9.2.15 
Investigational Medicinal Product Accountability ................................... 98 
9.2.16 
Adverse Events ......................................................................................... 98 
9.2.17 
Monitoring of Abuse Liability (for Patients 12 Years of Age and 
Older) ........................................................................................................ 99 
9.2.17.1 
Monitoring of Adverse Events .............................................................. 99 
9.2.17.1.1 
List of ‘Triggering Adverse Events of Interest’ ................................ 99 
9.2.17.1.2 
Supplemental Adverse Event Form ................................................. 100 
9.2.17.1.3 
Monitoring Drug Accountability Discrepancies ............................. 100 
9.2.17.1.4 
List of ‘Triggering Drug Accountability Discrepancies’ ................ 101 
9.2.17.1.5 
Supplemental Drug Accountability Form ....................................... 101 
9.2.17.2 
Site Classification Form ...................................................................... 101 
9.2.17.3 
Study Medication Use and Behavior Survey ...................................... 102 
9.2.17.4 
Adjudication Committee: Assessment of Abuse Potential of 
GWP42003-P ...................................................................................... 102 
10 
WITHDRAWAL .......................................................................... 105 
11 
URGENT SAFETY MEASURES .............................................. 107 
12 
ADVERSE EVENT REPORTING ............................................ 108 
12.1 
Definitions ................................................................................................. 108 
12.1.1 
Adverse Event ......................................................................................... 108 


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12.1.2 
Investigator ............................................................................................. 108 
12.2 
Serious Adverse Events ............................................................................. 108 
12.3 
Reporting Procedures for Serious Adverse Events ................................... 109 
12.4 
Pregnancy .................................................................................................. 110 
12.5 
Causality Assessment ................................................................................ 110 
12.6 
Reporting Procedures for All Adverse Events .......................................... 111 
12.7 
Follow-up Procedures for Adverse Events ................................................ 113 
12.8 
Potential Cases of Drug-induced Liver Injury .......................................... 113 
12.9 
Notification of Safety Information to Investigators, Regulatory 
Authorities and Ethics Committees. .......................................................... 114 
13 
STATISTICAL CONSIDERATIONS ....................................... 117 
13.1 
Sample Size, Power and Significance Levels ........................................... 117 
13.2 
Interim Analysis ........................................................................................ 117 
13.3 
Analysis Sets ............................................................................................. 118 
13.3.1 
Protocol Deviations ................................................................................ 118 
13.4 
General Considerations ............................................................................. 119 
13.5 
Accountability and Background Characteristics ....................................... 119 
13.5.1 
Enrollment and Disposition .................................................................... 119 
13.5.2 
Baseline and Demographic Characteristics ............................................ 119 
13.5.3 
Medical History ...................................................................................... 119 
13.5.4 
Concomitant Medication ........................................................................ 119 
13.6 
Endpoints and Statistical Methods ............................................................ 119 
13.6.1 
Evaluable Period ..................................................................................... 120 
13.6.2 
Primary Endpoint(s) ................................................................................ 121 
13.6.2.1 
Sensitivity Analysis for the Primary Endpoint.................................... 122 
13.6.3 
Secondary Endpoint(s) ............................................................................ 124 
13.6.4 
Pharmacokinetics .................................................................................... 127 
13.6.5 
Safety ...................................................................................................... 127 
13.6.5.1 
Treatment Compliance and Extent of Treatment Exposure ................ 127 
13.6.5.2 
Adverse Events.................................................................................... 127 
13.6.5.3 
Clinical Laboratory Data ..................................................................... 128 
13.6.5.4 
Vital Signs, 12-Lead Electrocardiogram, Physical Examination 
and Other Safety Data ......................................................................... 128 


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14 
SAFETY MONITORING COMMITTEE ................................ 129 
15 
REGULATORY AND ETHICAL OBLIGATIONS ................ 130 
15.1 
Declaration of Helsinki ............................................................................. 130 
15.2 
Informed Consent/Assent .......................................................................... 130 
15.3 
Ethics Committee/Institutional Review Board .......................................... 130 
15.4 
Pre-study Documentation Requirements ................................................... 131 
15.5 
Patient Confidentiality ............................................................................... 132 
16 
ADMINISTRATIVE AND LEGAL OBLIGATIONS ............. 133 
16.1 
Protocol Amendments and End of Study or Termination ......................... 133 
16.2 
Study Documentation and Storage ............................................................ 133 
16.3 
Study Monitoring and Data Collection ..................................................... 134 
16.4 
Electronic Data collected by Interactive Voice Response System ............ 135 
16.5 
Quality Assurance ..................................................................................... 135 
16.6 
Compensation ............................................................................................ 136 
16.7 
Publication Policy...................................................................................... 136 
16.8 
Intellectual Property Rights ....................................................................... 137 
16.9 
Confidential Information ........................................................................... 137 
17 
REFERENCES ............................................................................ 138 
 


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List of Appendices 
APPENDIX 1 
SCHEDULE OF ASSESSMENTS ........................................ 143 
APPENDIX 2 
TANNER STAGING ............................................................. 149 
APPENDIX 3 
STUDY PERSONNEL .......................................................... 152 
Appendix 3.1 
Investigator Details ................................................................ 152 
Appendix 3.2 
Sponsor Contact Details ......................................................... 152 
APPENDIX 4 
IVRS CALLS FOLLOWING END OF 
TREATMENT/WITHDRAWAL .......................................... 153 
 


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List of In-text Tables 
Table 5.1-1 
Formulation of GWP42003-P Solution ................................... 54 
Table 5.2-1 
Formulation of Placebo Solution ............................................. 54 
Table 8.1.2-1 
Dose Titration Regimen* ......................................................... 64 
Table 8.1.2-2 
Blinded Transition ................................................................... 65 
Table 8.1.2-3 
OLE Titration Schedule ........................................................... 65 
Table 9.2.9-1 
Biochemistry, Hematology, Urinalysis and THC Screen ........ 90 
Table 13.6-1 
Hierarchy for Analysis ........................................................... 120 
 


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List of In-text Figures 
Figure 1-1 
Study Design and Treatment Schema: Blinded Phase ............. 22 
Figure 1-2 
Study Design and Treatment Schema: Open-label 
Extension.................................................................................. 23 
Figure 9.2.17.4-1 
Flow Diagram for Identifying and Evaluating Clinical 
Trial Adverse Event Data Through Systematic 
Categorization, Tabulation and Analysis which can 
Illuminate an Abuse Potential Signal (for Patients 12 
Years of Age and Older) ........................................................ 104 
 


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List of Abbreviations 
ABCL 
Adult Behavior Checklist 
ACTH 
Adrenocorticotropic hormone 
AE 
Adverse Event 
AED 
Antiepileptic Drug(s)s 
ALT 
Alanine Aminotransferase 
ANCOVA 
Analysis of Covariance 
AST 
Aspartate Aminotransferase 
CBCL 
Child Behavior Checklist 
CBD 
Cannabidiol 
CGIC 
Caregiver Global Impression of Change 
CGIC-SD 
Caregiver Global Impression of Change in Seizure Duration 
CI 
Confidence Interval 
CIOMS 
Council for International Organizations of Medical Sciences 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
DRF 
Diagnostic Review Form for Epilepsy Study Consortium 
EAP 
Expanded Access IND Program 
EC 
Ethics Committee 
ECG 
12-Lead Electrocardiogram 
EEG 
Electroencephalogram 
ESC 
Epilepsy Study Consortium 
EU 
European Union 
FDA 
U.S. Food and Drug Administration 
GABA 
γ-aminobutyric acid 
GCP 
Good Clinical Practice 
GW 
GW Research Ltd 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation 
IGF-1 
Insulin-like growth factor-1 


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IMP 
Investigational Medicinal Product 
IND 
Investigational New Drug 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
ITT 
Intention to treat 
IVRS 
Interactive Voice Response System 
MAR 
Missing at Random 
MNAR 
Missing Not at Random 
mTOR 
Mammalian target of rapamycin 
MI 
Multiple Imputation 
OLE 
Open-label Extension 
PGIC 
Physician Global Impression of Change 
PI 
Principal investigator 
PK 
Pharmacokinetics 
PP 
Per protocol 
PRN 
Packaging Reference Number 
PVD 
Pharmacovigilance Department 
QOLCE 
Quality of Life in Childhood Epilepsy 
QOLIE-31-P 
Quality of Life in Epilepsy 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SCQ 
Subject Communication Questionnaire 
SGIC 
Subject Global Impression of Change 
SGIC-SD 
Subject Global Impression of Change in Seizure Duration 
SEGAs 
Subependymal giant-cell astrocytomas 
SENs 
Subependymal nodules 
SMC 
Safety Monitoring Committee 
SOC 
System Organ Class 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
TAND 
TSC-associated neuropsychiatric disorders 
TBL 
Total Bilirubin 
THC 
Δ9-Tetrahydrocannabinol 


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TSC 
Tuberous sclerosis complex 
ULN 
Upper Limit of Normal 
VFDs 
Visual field defects 
VGB 
Vigabatrin 
 


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Definition of Terms 
Term 
Definition 
Baseline 
The 28-day (+3 days) period from screening to 
randomization. 
Day 1 
The day a patient first receives investigational medicinal 
product in this study. 
End of study 
Last patient last visit or last contact, whichever occurs last. 
Enrolled patient 
Patient is considered enrolled in the study from the time of 
providing written informed consent. 
IMP 
Investigational Medicinal Product (Study Medication). 
International 
Normalized Ratio 
A calculation made to standardize prothrombin time. 
Investigator 
Study principal investigator or a formally delegated study 
physician. 
Status epilepticus 
Any seizure lasting 30 minutes or longer.  
 


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2 
OBJECTIVES 
2.1 
Primary 
Blinded Phase: 
To evaluate the efficacy of GWP42003-P as add-on therapy in reducing the frequency 
of seizures when compared with placebo in patients with tuberous sclerosis complex 
(TSC).  
Open-label Extension: 
To evaluate via the adverse events (AE) profile the long term safety and tolerability of 
GWP42003-P as add-on therapy in children and adults with TSC who experience 
inadequately-controlled seizures.  
2.2 
Secondary 
Blinded Phase: 
• To evaluate the effect of GWP42003-P compared with placebo on 
antiepileptic measures. 
• To evaluate the effect of GWP42003-P on growth and development (in 
patients less than 18 years old) compared with placebo. 
• To evaluate the effects of GWP42003-P on quality of life compared with 
placebo. 
• To evaluate the safety and tolerability of GWP42003-P compared with 
placebo. 
Open-label Extension: 
• To evaluate the long term effects of GWP42003-P, as add-on therapy, on 
antiepileptic measures. 
• To evaluate the long term effect of GWP42003-P on growth and development 
(in patients less than 18 years old). 
• To evaluate the long term effects of GWP42003-P on quality of life. 
• To evaluate the long term safety and tolerability of GWP42003-P. 


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2.3 
Exploratory 
Blinded Phase: 
• To evaluate the effect of GWP42003-P on TSC-associated neuropsychiatric 
disorders (TAND), including cognitive and behavioral function and autistic 
features compared with placebo. 
• To determine the pharmacokinetics (PK) of CBD, and its major metabolites 
following single and multiple doses of GWP42003-P.  
• To evaluate the effects of GWP42003-P on plasma concentrations of 
concomitant antiepileptic drugs (AEDs), if applicable. 
Open-label Extension: 
• To evaluate the long term effect of GWP42003-P on TAND, including 
cognitive and behavioral function and autistic features. 


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3 
BACKGROUND AND RATIONALE 
3.1 
Disease 
TSC is a genetic disorder characterized by the formation of nonmalignant tumors 
(tubers) in multiple organ systems.  The clinical signs of TSC arise as a result of 
inactivating mutations in either of two tumor suppressor genes: TSC1 (located on 
chromosome 9q34.131) or TSC2 (located on chromosome 16p13.32).  TSC1 encodes 
the 130-kDa protein TSC1 (hamartin)1 whilst TSC2 encodes the 200-kDa protein 
TSC2 (tuberin)2.  TSC1 and TSC2 share no homology yet bind to each other with 
high affinity to form a functional heterodimer3 which suppresses the mammalian 
target of rapamycin (mTOR), a key regulator of cell growth and proliferation4.  Thus, 
inactivating mutations in TSC1 and TSC2 lead to inadequate suppression of mTOR 
signaling, resulting in abnormal cellular growth and tumorigenesis5,6.  TSC is 
transmitted in an autosomal dominant pattern of inheritance, although two-thirds of all 
cases are caused by de novo mutations2,7,8.  Mutations in TSC1 account for 
approximately 15% of all cases of TSC whilst approximately 70% of all cases are due 
to mutations in TSC2; ~15% of TSC patients have no identifiable mutation in the 
coding regions of either gene8,9.  Generally, TSC2 mutations result in a more severe 
disease phenotype compared with TSC1 mutations8,9.  The birth incidence of TSC is 
estimated to be 1 in 6,000 with approximately 50,000 individuals in the United States 
and 1 million individuals worldwide affected10,11. 
Tumors in TSC patients can occur in any major organ yet develop primarily in the 
brain, eyes, heart, kidney, skin and lungs12.  The random location, number, size and 
distribution of tumors result in a great variety of clinical manifestations, yet most 
patients exhibit dermatological, renal and/or neurological abnormalities, which appear 
at distinct developmental points13.  Dermatological abnormalities generally first 
appear in infancy or early childhood and include hypomelanotic macules, which are 
present in more than 90% of TSC patients, and facial angiofibromas, found in 
approximately 75% of TSC patients7,14,15.  In contrast, renal abnormalities tend not to 
develop until late childhood/adolescence and include angiomyolipomas (found in  
50–70% of TSC patients), renal cysts (found in 25–35% of TSC patients) and, very 
rarely, renal-cell carcinomas (found in 2–3% of TSC patients)16,17,18.  Neurological 
abnormalities first appear during embryogenesis and include cerebral cortical tubers 
and subependymal nodules (SENs), each of which are found in 80–90% of TSC 


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patients, as well as subependymal giant-cell astrocytomas (SEGAs), which are 
presumed to derive from SENs and are found in 5–15% of TSC patients19.  Whereas 
SENs and SEGAs are usually asymptomatic, the presence of cortical tubers is widely 
believed to underlie the neurologic manifestations of TSC, which include epilepsy, 
cognitive disability and autism12,13,19. 
Epileptic seizures are the most common clinical manifestation of TSC, affecting more 
than 70% of patients9,20,21,22.  Seizure onset occurs within the first year of life in 
approximately two-thirds of TSC patients and occurs within the first 3 years of life in 
80% of TSC patients13,20.  The onset of epilepsy in TSC commonly manifests as focal 
motor seizures, which in approximately one-third of TSC patients coexist with 
infantile spasms20.  Interictal electroencephalogram (EEG) recordings at onset 
typically show hypsarrhythmia, characterized by focal or multifocal spike discharges 
and irregular slow-wave activity23.  Virtually all TSC patients with infantile spasms 
and approximately half of all epileptic TSC patients without them develop multiple 
seizure types, including complex focal seizures (with or without secondary 
generalization), generalized tonic–clonic seizures, atonic seizures, and atypical 
absences20.  Although infantile spasms resolve with time, the frequency and severity 
of other seizures tend to increase throughout early childhood and nearly two-thirds of 
TSC patients develop medically intractable epilepsy, including Lennox–Gastaut 
syndrome20.  Cognitive impairment (intelligence/developmental quotient < 70) is 
observed in around 60% of all TSC patients with a history of seizures and in 
approximately three-quarters of all TSC patients with a history of refractory 
epilepsy20.  Early management of seizures is therefore important in preventing 
subsequent epileptic encephalopathy and in reducing the associated cognitive and 
neuropsychiatric consequences22,24. 
In both the European Union and the United States, the drug of first choice for the 
treatment of infantile spasms secondary to TSC is vigabatrin (VGB), which was 
approved by the U.S. Food and Drug Administration (FDA) in 2009 (as Sabril®) to 
treat infantile spasms in children aged 1 month to 2 years25.  VGB is a structural 
analog of γ-aminobutyric acid (GABA; the major inhibitory neurotransmitter in the 
central nervous system) that irreversibly inhibits GABA-transaminase and thereby 
increases brain levels of GABA26.  The initial prospective clinical study compared 
VGB (100–150 mg/kg/day) with adrenocorticotropic hormone (ACTH; 10 IU/day) in 
42 patients with infantile spasms, only 4 of whom were diagnosed with TSC (3 


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received VGB; 1 received ACTH)27.  Although all 4 TSC patients became spasm-free 
after 20 days’ treatment (irrespective of which therapy was received), VGB was 
considered more effective than ACTH for the treatment of infantile spasms due to 
TSC27.  In a separate randomized trial which compared VGB (150 mg/kg/day, n = 11) 
with the oral steroid hydrocortisone (15 mg/kg/day, n = 11) for the treatment of 
infantile spasms due to TSC, 100% of patients taking VGB were spasm-free after 
1 month’s treatment compared with 45% taking hydrocortisone28.  Furthermore, of 
the non-responders who received hydrocortisone, all became spasm-free on switching 
to VGB therapy28.  A larger study compared 2 doses of VGB in treatment-naïve 
patients with infantile spasms29,30.  Of the patients with TSC, 52% were spasm-free 
after 2 weeks’ treatment compared with 16% of patients with other etiologies29.  
Furthermore, 92% of TSC patients who began VGB therapy were spasm-free after 
71 days’ treatment, although whether these patients received additional treatments 
during this time is unclear29.  Following recruitment of more patients into the trial and 
use of intent-to-treat analysis, however, only 21% of TSC patients could be classed as 
primary responders after 2 weeks’ treatment compared with 9% of patients with other 
etiologies30.  Although VGB is generally well tolerated, long term treatment with 
VGB is associated with irreversible peripheral visual field defects (VFDs), the risk of 
which increases with increasing dose and cumulative exposure26.  The prevalence of 
VGB-associated VFDs in children with refractory complex focal seizures is 
approximately 15%26; however, a very recent study found that 60% of TSC patients 
who received VGB treatment for infantile spasms subsequently developed VFDs31. 
Furthermore, there is evidence that spasms may relapse and become refractory to 
VGB following discontinuation of treatment in children with focal cortical 
dysplasia/TSC32. 
ACTH (corticotropin) is a long-established therapy for infantile spasms and was 
approved by the FDA in 2010 (as Acthar® Gel) as monotherapy in infants and 
children younger than 2 years.  Although a number randomized controlled trials have 
demonstrated efficacy for ACTH in the treatment of infantile spasms and resolution of 
hypsarrhythmia, many of these studies do not provide TSC-specific data33.  Side 
effects are common with ACTH treatment and long term exposure is associated with 
serious adverse events (SAEs), including fulminant infections secondary to 
immunosuppression, hypertension, glucosuria and metabolic abnormalities25,34.  
Furthermore, there is evidence that ACTH may contribute to the enlargement of 


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cardiac rhabdomyoma in TSC patients35,36.  ACTH treatment is therefore generally 
short-term (~2 weeks followed by taper) and close monitoring is required in TSC 
patients with cardiac rhabdomyoma.  Relapse rates following effective ACTH 
treatment range from 15–60%33.  Oral corticosteroids (prednisone/prednisolone) have 
also been used to treat infantile spasms, although randomized controlled trials 
demonstrate that even at very high doses only ~30–60% of patients achieve freedom 
from spasms37,38,39,40. 
The mTOR inhibitor everolimus (the 40-O-[2-hydroxyethyl] derivative of 
sirolimus/rapamycin) has demonstrated efficacy in reducing seizure frequency in TSC 
patients with SEGA41.  In an open-label study of add-on everolimus (3 mg/m2/day; 
n = 16), 56% of patients had a clinically-relevant reduction in total seizure frequency 
at 6 months42.  In a randomized controlled trial comparing everolimus 
(4.5 mg/m2/day; n = 78) with placebo (n = 39), analysis of change in seizure frequency 
was inconclusive because most patients had no seizures at baseline or at 24 weeks’ 
follow-up43.  As both studies demonstrated significant reductions in SEGA volume, 
the FDA approved everolimus in 2010 (as Afinitor®) and in 2012 (as Afinitor 
Disperz™) for the treatment of TSC patients with SEGA who are not eligible for 
curative surgical resection.  In addition to resective surgery, other non-
pharmacological treatments of TSC-associated epilepsy include vagus nerve 
stimulation and the introduction of a ketogenic diet22. 
3.2 
GWP42003-P Background 
The investigational medicinal product (IMP), GWP42003-P, is formulated from 
extracts prepared from Cannabis sativa L. plants that have a defined chemical profile 
and contain consistent levels of CBD as the principal phytocannabinoid.  Extracts 
from these plants are processed to yield purified (≥ 98%) CBD that typically contains 
less than 0.15% (w/w) THC (for oral formulations).  The purified CBD is 
subsequently dissolved in excipients with added sweetener and flavoring. 
The pharmacological effects of phytocannabinoids are thought to be mediated 
primarily via their interaction with the endocannabinoid system, which consists of 
cannabinoid receptors, endogenous ligands (endocannabinoids) and enzymes for 
endocannabinoid synthesis and degradation.  To date, 2 G-protein-coupled receptors 
for cannabinoids have been identified, designated CB1 receptor and CB2 receptor. 
CBD does not bind to either of these receptors with any great affinity but does 


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modulate the metabolizing enzymes of the endocannabinoid system.  CBD also 
affects conduction of ion channels and acts on other G-protein-coupled receptors such 
as the transient receptor potential channel TRPV144 and the orphan receptor GPR5545. 
Importantly, CBD lacks the psychoactivity associated with THC. Further to this, CBD 
has demonstrated anticonvulsant, antipsychotic, anxiolytic, neuroprotective, 
antioxidant and anti-inflammatory activity46.  Very little data concerning AEs of CBD 
in humans currently exist; however, in the small number of placebo-controlled trials 
published to date investigating the anticonvulsant effects of CBD, few side effects 
have been reported after 4–12 months of 200–300 mg/day CBD46. 
3.3 
Rationale 
The pharmacological therapies currently available for TSC-associated epilepsy often 
produce serious adverse effects, and a significant proportion of patients (37–63%) 
become resistant to treatment20,21.  Consequently, there is a clear need for new, 
efficacious pharmaceutical treatments for refractory epilepsy.  Given the limitations 
of current synthetic AEDs, it has been suggested that CBD should be tested for 
anticonvulsive efficacy in randomized controlled clinical trials, especially in infantile 
epileptic syndromes46.  Although there are no published reports to date investigating 
the efficacy of CBD for seizures in TSC patients, a recent parent survey has reported 
that 84% of children with treatment-resistant epilepsy experienced a reduction in 
seizures whilst taking CBD-enriched cannabis, with over half of those reporting 
> 80% reduction in seizure frequency47.  The CBD-enriched cannabis was 
behaviorally well tolerated and children often experienced improved sleep, increased 
alertness, and better mood. 
3.3.1 
Selection of Study Dose 
Doses up to 800 mg CBD per day for up to 8 weeks have been well tolerated in adults 
in the GW Research Ltd (GW) clinical study GWMD0911248, which — assuming an 
average weight of 70 kg — equates to 11.4 mg/kg.  In the literature, doses of CBD 
have been given up to 1500 mg CBD per day for 4 weeks in adults49, which, in a 
70 kg human, equates to a daily dose of 21.4 mg/kg CBD.  
At the time of dose selection, GWP42003-P was being used by physicians for 
treatment of patients with intractable epilepsy resulting from a variety of etiologies in 
a number of Individual and Intermediate Expanded Access Investigational New Drug 
(IND) studies.  In the ongoing Individual Expanded Access IND studies, the initial 


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dosing had been cautious (100 mg [morning] + 150 mg [afternoon/evening]), 
progressively increasing to 400 mg/day CBD; doses up to 22 mg/kg/day had been 
well tolerated in an individual pediatric patient.  The sponsor reviews all safety 
information on an ongoing basis from the patients in the Individual Expanded Access 
IND studies and is not aware of any safety issues arising from the dosing used to date. 
In the Expanded Access IND program (EAP), clinical dosing is determined on a 
case-by-case basis, balancing seizure control with tolerability, and shows that patients 
had tolerated doses up to 50 mg/kg/day.  In a data review of the EAP, the median dose 
was 25 mg/kg/day among 230 patients treated for at least 12 weeks (EAP; data cut 
Sep 2015). 
The first patient was dosed on 22 Jan 2014 and at the Sep 2015 data cut 350 patients 
with severe treatment-resistant epilepsies in the EAP (predominantly children) had 
received CBD oral solution; the median duration of exposure was 202 days.  The 
available safety data collected from these patients showed that the reported AEs were 
usually mild or moderate in severity and resolved without treatment.  There had been 
few withdrawals due to AEs.  The median dose of CBD oral solution was 
25 mg/kg/day after 12 weeks of treatment.  24 patients achieved a dose > 30 mg/kg up 
to and including 40 mg/kg and 37 patients were dosed in the higher category 
> 40 mg/kg up to and including 50 mg/kg.  The highest dose had been 51 mg/kg 
(1 patient). 
Doses of 25 and 50 mg/kg/day have been chosen for the GWEP1521 study to cover 
the doses of CBD oral solution most likely to have an effect in controlling multiple 
seizure types in TSC.  The two doses will also allow demonstration of a possible dose 
response in TSC.  Dose escalation for each patient in this study is subject to the 
investigator’s assessment of safety and tolerability.  If AEs become dose limiting, the 
investigator may consider temporarily or permanently reducing the dose for the 
remainder of the study.  Dose limiting AEs have so far recovered/were resolving with 
dose adjustment or cessation. 
The maximum dose patients can receive during the maintenance period of the blinded 
phase will be 50 mg/kg/day.  During the open-label phase, the maximum dose patients 
can receive will be 50 mg/kg/day although all patients will initially titrate to 
25 mg/kg/day.  The maximum dose was based on data from the Intermediate EAP at 
the time of initiation of GWEP1521.  
Please refer to the Investigator’s Brochure (IB)51 and Development Core Safety 
Information for the most current safety data. 


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3.4 
Clinical Hypothesis 
The primary clinical hypothesis is that there will be a difference between the 
GWP42003-P dose groups and placebo in their effect on focal seizure frequency. 
This study will also evaluate the effect of GWP42003-P compared with placebo on 
further measures of antiepileptic efficacy (responder analysis, focal seizure score, 
number of focal seizure-free days, number of seizures by subtype, number of 
infantile/epileptic spasms, usage of rescue medication, number of episodes of status 
epilepticus, duration of seizure subtypes), cognitive and behavioral function, autistic 
features, and quality of life.  These endpoints are among those recommended by the 
European Medicines Agency guideline on clinical investigation of medicinal products 
in the treatment of epileptic disorders50. 
The dose response relationship between two GWP42003-P Dose Levels 
(25 mg/kg/day and 50 mg/kg/day) and placebo will also be explored. 


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4 
EXPERIMENTAL PLAN 
4.1 
Study Design 
This multicenter study consists of a randomized, placebo-controlled, double-blind 
phase followed by an open-label extension (OLE) phase. 
Blinded Phase: 
The blinded phase of the study is a randomized, double-blind, parallel-group, 16-week 
comparison of two doses of GWP42003-P versus placebo.  Patients will complete a 
1-week screening period and a 4-week baseline period before they are randomized to 
receive 25 mg/kg/day GWP42003-P, 50 mg/kg/day GWP42003-P or equivalent 
volumes of placebo.  Randomization will be stratified by age according to the 
following ranges: 1–6, 7–11, 12–17 years and 18+ years.  Patients will begin a 4-week 
dose escalation period, titrating up to their assigned dose, before continuing on a 
stable dose of blinded IMP for 12 weeks.  
Dose escalation for each patient is subject to the investigator’s assessment of safety 
and tolerability.  If a dose becomes poorly tolerated, the investigator may consider 
temporarily or permanently reducing the dose for the remainder of the study. 
Clinic visits will occur for screening (Day −35), baseline (Day −28), randomization 
(Day 1) and, on Days 15 and 29 during titration and on Days 43, 57, 71 (telephone) 
and 85 until the end of treatment (Day 113).  Safety telephone calls will be completed 
every two days during titration, one week after the end of titration and, for patients 
not entering the OLE, weekly from Visit 10 to Visit 12 (refer to Section 9.1.2.14 for 
further details on safety telephone calls).  If the call falls on a weekend, it is permitted 
to schedule the call for the Friday before or Monday after the weekend instead. 
Patients will be required to perform daily interactive voice response system (IVRS) 
telephone calls to record seizure information.  They will also complete a daily paper 
diary with information about their IMP and concomitant AED administration.  
Following completion of the blinded phase, patients will be invited to continue to 
receive GWP42003-P in an OLE.  
Those patients opting not to enter the OLE will complete a 10-day taper period 
(down-titrating 10% per day for 10 days).  
Open-label Extension Transition: 
In order to maintain consistent exposure to IMP and maintain the integrity of the 
blind, patients will enter a 2-week blinded transition to the OLE.  OLE IMP will be 


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titrated up to 25 mg/kg/day whilst blinded IMP is simultaneously tapered down to 
zero. All patients will complete the transition and enter the OLE taking 25 mg/kg/day 
GWP42003-P:  
• Patients from the placebo group will titrate up to 25 mg/kg/day GWP42003-P. 
• Patients from the 25 mg/kg/day GWP42003-P group will continue to take 
25 mg/kg/day GWP42003-P. 
• Patients from the 50 mg/kg/day GWP42003-P group will taper down (10% per 
day) to 25 mg/kg/day GWP42003-P. 
Safety telephone calls will be completed every two days throughout the OLE 
transition.  If the call falls on a weekend, it is permitted to schedule the call for the 
Friday before or Monday after the weekend instead. 
Open-label Extension: 
The OLE consists of a 3-week titration period followed by a maintenance period and a 
10-day taper period.  The initial OLE period will last for a maximum of 1 year. 
Following titration according to the titration schedule, patients will continue with their 
optimal GWP42003-P dose.  However, investigators may decrease the dose if a 
patient experiences intolerance, or increase the dose to a maximum of 50 mg/kg/day if 
required for better seizure control, until the optimal dose is found. Dose increases 
above 25 mg/kg/day are recommended to be done slowly, with maximum increments 
of 2.5 mg/kg/day every two days.  Patients whose dose has been decreased can have 
their dose increased again provided there is adequate tolerance.  Safety telephone calls 
will be completed every two days throughout the OLE titration and one week after the 
end of titration.  If the call falls on a weekend, it is permitted to schedule the call for 
the Friday before or Monday after the weekend instead.  If seizure freedom is 
achieved with use of GWP42003-P during the study, the investigator should consider 
reducing the dose of concomitant AEDs after six months of seizure freedom. 
4.1.1 
Primary Endpoint 
Blinded Phase: 
The primary endpoint is the change in number of TSC-associated seizures* during the 
treatment period (maintenance and titration) compared to baseline in patients taking 
GWP42003-P compared with placebo. 


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*Primary endpoint TSC-associated seizures include: focal motor seizures without 
impairment of consciousness or awareness; focal seizures with impairment of 
consciousness or awareness; focal seizures evolving to bilateral generalized 
convulsive seizures and generalized seizures (tonic–clonic, tonic, clonic or atonic) 
that are countable.  
Open-label Extension: 
The safety of GWP42003-P will be evaluated by assessing the incidence, type and 
severity of AEs.  
4.1.2 
Secondary Endpoint(s) 
Blinded Phase: 
The following endpoints will be compared between treatment groups over the 
16-week, double-blind treatment period (all changes relative to baseline): 
Key: 
• Number of patients considered treatment responders defined as those with a 
≥ 50% reduction in TSC-associated seizure* frequency.  
• Change in Caregiver Global Impression of Change (CGIC) or Subject Global 
Impression of Change (SGIC) score. 
• Change in total seizures. 
Other: 
Antiepileptic Efficacy Measures: 
• Number of patients considered treatment responders defined as those with a 
≥ 25%, ≥ 50%, ≥ 75% or 100% reduction in TSC-associated seizure* 
frequency. 
• Number of patients experiencing a > 25% worsening, − 25 to + 25% no 
change, 25–50% improvement, 50–75% improvement or > 75% improvement 
in TSC-associated seizure* frequency. 
• Change in number of TSC-associated seizure*-free days. 
• Change in number of ‘other’ seizures (absence, myoclonic, focal sensory and 
infantile/epileptic spasms). 
Growth and Development (in patients less than 18 years old): 


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• Change in serum insulin-like growth factor-1 (IGF-1) levels. 
• Change in Tanner Staging score (for patients aged 10–17 [inclusive]). 
Quality of Life: 
• Changes in the Quality of Life in Childhood Epilepsy (QOLCE; patients 2–18 
years) or Quality of Life in Epilepsy (QOLIE-31-P; patients 19+ years) score. 
• Change in Physician Global Impression of Change (PGIC) score. 
Safety and Tolerability: 
• AEs. 
• Clinical laboratory parameters. 
• 12-lead electrocardiogram (ECG). 
• Physical examination parameters (including height and weight). 
• Vital signs. 
• Columbia-Suicide Severity Rating Scale (C-SSRS; 19+ years) or C-SSRS 
Children’s (6–18 years) score, where applicable.  
• Number of inpatient hospitalizations due to epilepsy. 
• Abuse liability. 
• Effects on menstruation cycles (in females). 
Open-label Extension: 
The following endpoints will be assessed relative to the pre-randomization baseline of 
the blinded phase: 
*TSC-associated seizures include: focal motor seizures without impairment of 
consciousness or awareness; focal seizures with impairment of consciousness or 
awareness; focal seizures evolving to bilateral generalized convulsive seizures and 
generalized seizures (generalized tonic–clonic, tonic, clonic or atonic) that are 
countable. 
Key: 
• Percentage change in number of TSC-associated seizures* (average per 
28 days). 


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• Number of patients considered treatment responders defined as those with a 
≥ 50% reduction in TSC-associated seizure frequency*.  
• Change in CGIC or SGIC score. 
• Change in total seizures. 
Other: 
Antiepileptic Efficacy Measures: 
• Number of patients considered treatment responders, defined as those with a 
≥ 25%, ≥ 50% %, ≥ 75% or 100% reduction in TSC-associated seizure* 
frequency. 
• Number of patients experiencing a > 25% worsening, − 25 to + 25% no 
change, 25–50% improvement, 50–75% improvement or > 75% improvement 
in TSC-associated seizure* frequency. 
• Change in number of TSC-associated seizure*-free days. 
• Change in number of ‘other’ seizures (absence, myoclonic, focal sensory and 
infantile/epileptic spasms). 
Growth and Development (patients less than 18 years): 
• Change in serum IGF-1 levels. 
• Change in Tanner Staging score (for patients aged 10–17 [inclusive]). 
Quality of Life: 
• Changes from baseline in the QOLCE (patients 2–18 years) or QOLIE-31-P 
(patients 19+ years) score. 
• Change in PGIC score. 
Safety and Tolerability: 
• Clinical laboratory parameters. 
• ECG. 
• Physical examination parameters (including height and weight). 
• Vital signs. 
• C-SSRS (19+ years) or C-SSRS Children’s (6–18 years) score, where 
applicable.  


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• Number of inpatient hospitalizations due to epilepsy. 
• Abuse liability. 
• Effects on menstruation cycles (in females). 
Exploratory Endpoints (Double-blind and OLE) 
Antiepileptic Efficacy Measures: 
• Change in composite focal seizure score (frequency × severity). 
• Change in number of seizures by subtype. 
• Change in use of rescue medication. 
• Change in the number of episodes of status epilepticus (convulsive and 
non-convulsive). 
• Changes in duration of seizure subtypes as assessed by the Subject Global 
Impression of Change in Seizure Duration (SGIC-SD) or the Caregiver Global 
Impression of Change in Seizure Duration (CGIC-SD). 
TAND: 
Cognitive and Behavioral Function: 
• Changes in Vineland Adaptive Behavior Scales, Second Edition (Vineland-II). 
• Changes in Wechsler Scales (pre-school, primary, children, adult). 
• Changes in Achenbach Child Behavior Checklist (CBCL) and Adult Behavior 
Checklist (ABCL). 
Autistic Features: 
• Change in Social Communication Questionnaire (SCQ) score. 
PK (Double-blind only): 
• The plasma concentrations will be summarized by time window for CBD and 
its major metabolites following single and multiple doses of GWP42003-P.  
Where data allows, the area under the plasma concentration curve (AUC0-t) 
from time zero to the last measurable time-point will be calculated. 
• Plasma concentrations of concomitant AEDs before and after treatment with 
GWP42003-P, where available. 


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4.2 
Number of Centers 
Approximately 40 centers are expected to participate in this study. 
4.3 
Number of Patients 
Blinded Phase: 
A total of 210 patients will be targeted to be enrolled.  The 210 patients will be 
randomly allocated to one of four treatment groups (GWP42003-P 25 mg/kg/day, 
GWP42003-P 50 mg/kg/day, placebo 25 mg/kg/day dose volume equivalent, or 
placebo 50 mg/kg/day dose volume equivalent) at a 2:2:1:1 ratio.  The placebo groups 
will be pooled for the analyses of efficacy.  If it is assumed that patients in the placebo 
group will experience a mean reduction in seizure frequency of 15% (from baseline), 
patients receiving GWP42003-P will experience at least a 50% reduction in seizures 
and a common standard deviation of 60%, then this sample size of 70 patients per 
group will be sufficient to detect a difference in response distributions with 90% 
power.  This test is based on a two-sided non-parametric Mann-Whitney-Wilcoxon 
test for continuous response data with a 5% significance level.  
Open-label Extension: 
All patients who wish to continue on IMP following the blinded phase. 
The sample size calculation is explained fully in Section 13.1. 


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5 
INVESTIGATIONAL MEDICINAL PRODUCT 
Please refer to the separate Pharmacy Manual for more detailed information on the 
IMP. 
5.1 
GWP42003-P Solution 
GWP42003-P solution is presented as a clear, colorless to yellow solution containing 
100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (10% 
v/v) with added sweetener (sucralose) and strawberry flavoring (Table 5.1-1). 
Table 5.1-1 
Formulation of GWP42003-P Solution 
Material 
Quantity 
CBD 
100 mg/mL 
Anhydrous ethanol 
79 mg/mL 
Sucralose 
0.5 mg/mL 
Strawberry flavoring 
0.2 mg/mL 
Sesame oil 
make up to 1 mL 
5.2 
Placebo Solution 
Placebo solution is presented as a clear, colorless to yellow oily solution containing 
the excipients sesame oil and anhydrous ethanol (10% v/v) with added sweetener 
(sucralose) and strawberry flavoring (Table 5.2-1). 
Table 5.2-1 
Formulation of Placebo Solution 
Material 
Quantity 
Anhydrous ethanol 
79 mg/mL 
Sucralose 
0.5 mg/mL 
Strawberry flavoring 
0.2 mg/mL 
Sesame oil 
make up to 1 mL 
5.3 
Packaging, Storage and Drug Accountability 
5.3.1 
Packaging and Labeling  
The IMP will be manufactured, packaged, labeled and/or distributed by G-Pharm or 
delegated contractors.  The IMP will be presented in 100 mL amber glass bottles with 
child-resistant caps and packed in cartons.  Sufficient IMP will be dispensed at each 
relevant visit considering the dose group and weight of each patient.  A unique 
identification number will be used to identify each box and the IMP it contains.  The 
unique identification number together with the packaging reference number (PRN) 
will permit full traceability of manufacture, pack and label activities conducted at or 
on behalf of G-Pharm and the IMP information held on the IVRS.  G-Pharm will 


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ensure that all IMP provided is fully labeled and packaged.  Label text will include the 
following information, as a minimum: 
• Sponsor’s name. 
• Product identification (e.g., “GWP42003-P/placebo”). 
• Dose and/or Potency. 
• Expiry date. 
• Storage conditions. 
• Instruction: “For clinical trial use only”. 
• Instruction: “Keep out of the sight and reach of children”. 
In addition, any local country requirements in accordance with local Drug Law or 
Regulatory Requirement will be included in the final label text. 
The IMP labels for the blinded phase and the open-label phase of the trial will have 
different colors, so these can be easily distinguished by the patients.  Directions of 
use, name, address and the telephone number of the investigator (or main contact for 
information about the product or the clinical trial) will be provided separately to the 
patient.  Patients will be instructed to retain and carry this information with them at all 
times. 
5.3.2 
Storage 
The IMP must be stored upright at room temperature (< 30°C) and must not be 
refrigerated or frozen.  It must also be kept away from heat and direct sunlight. 
The IMP must be stored in compliance with the local regulations for a controlled drug 
(if applicable to country).  The sponsor must approve storage location and facilities. 
Temperature records of the clinical site storage location must be maintained 
(recording a minimum of Monday–Friday, excluding public holidays) from date of 
receipt of first shipment until end of study dispensing period at each center.  These 
records must contain at least the minimum and maximum daily temperatures and 
should be made available to the appropriate GW personnel for review throughout the 
study.  Temperature records taken during transit of IMP to center must be checked on 
receipt. 
Should storage conditions deviate from these specified requirements, the GW study 
monitor must be contacted immediately to confirm if the IMP remains suitable for 


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use.  IMP should be placed under quarantine until written confirmation is received 
that IMP is suitable for use. 
IMP will be transported to country depots and clinical sites in compliance with Good 
Distribution Practice guidelines. 
5.3.3 
Supply and Return of Investigational Medicinal Product 
All IMP will be shipped to approved depot facilities and clinical sites with a Product 
Release Certificate that includes a physical description of the product for confirmation 
of identity on receipt.  
Once a center has been activated via the IVRS at study initiation, IMP will be shipped 
to the identified responsible person, such as the pharmacist, at the investigator’s 
center, who will check the amount received (against the IVRS Shipment Request) and 
condition of the drug (i.e., integrity, physical appearance, temperature during transit).  
Details of IMP received will be recorded in the IMP accountability record (see 
Section 5.3.4).  The center will acknowledge IMP receipt via the IVRS and will 
complete any receipt forms required.  IMP will be dispensed and returned as detailed 
in Section 8.4 with further IMP shipments to be initiated by IVRS.  As directed, all 
supplies, including unused, partially used, or empty containers, will be returned to 
G-Pharm/depot or destroyed at a G-Pharm-approved site if agreed in writing by the 
study monitor. 
5.3.4 
Investigational Medicinal Product Accountability 
The investigator has overall responsibility for the accountability of all used and 
unused IMP.  A drug accountability record for the IMPs must be kept current and 
should contain: 
• Study Code. 
• PRN, Treatment number, date of receipt and quantity of IMP received. 
• Patient’s trial identification and/or Treatment number. 
• Date and quantity of IMP dispensed. 
• The initials of the dispensing/dosing party. 
• Date and quantity of IMP returned to the investigator. 
• IMP expiry dates. 


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IMP will be dispensed at Visits 3, 4, 5, 6, 7, 9 and 10 (patients not entering the OLE) 
during the blinded phase and Visits B1, B2, B3, B4, B5, B6, B7, B8 and B9.  All 
patients will be asked to return all IMP (used and unused) to each subsequent visit.  
Any discrepancies will be discussed with the patient or their caregiver at the time of 
the visit and documented accordingly within the patient’s source documents. 
The investigator must inform GW promptly of all missing or unaccountable IMP. 
A record of returned IMP must be completed and included in the shipment of used 
and unused IMP to GW or the relevant Drug Distribution Depot.  At the end of the 
study, a record/statement of reconciliation must be completed and provided to GW. 
These inventories must be made available for inspection by an authorized GW 
representative and local officials or regulatory agency inspectors.  
Please refer to the separate Pharmacy Manual for more detailed information on the 
IMP. 


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6 
PATIENT ELIGIBILITY 
Investigators are responsible for confirming patient eligibility and will be required to 
maintain a log that includes limited information about all screened patients (initials, 
age, sex; as allowed per local regulations) and outcome of screening.  After the 
screening visit, investigators will submit the patient’s documented history of seizures 
directly to the Epilepsy Study Consortium (ESC) for verification of seizure types.  
The ESC may ask the investigator for additional information to assist in their 
decision.  The decision will be made within 14 days of receipt of all required 
information and the ESC will provide written confirmation directly to the investigator. 
6.1 
Inclusion Criteria 
For inclusion in the study, patients must fulfil ALL of the following criteria: 
6.1.1 Patient is male or female aged between one and 65 years inclusive. 
6.1.2 Patient and/or parent(s)/legal representative is willing and able to give 
informed consent/assent for participation in the study (see Section 15.2). 
6.1.3 Patient and their caregiver are willing and able (in the investigator’s opinion) 
to comply with all study requirements (including accurate diary and IVRS 
completion). 
6.1.4 Well-documented clinical history of epilepsy, which is not completely 
controlled by their current AEDs.  
6.1.5 Clinical diagnosis of TSC according to the criteria agreed by the 2012 
International Tuberous Sclerosis Complex Consensus Conference19.  
6.1.6 Taking one or more AEDs at a dose which has been stable for at least four 
weeks prior to screening. 
6.1.7 All medications or interventions for epilepsy (including ketogenic diet and any 
neurostimulation devices for epilepsy) must have been stable for one month 
prior to screening and the patient is willing to maintain a stable regimen 
throughout the study. 
6.1.8 Patient is willing to keep any factors expected to affect seizures stable (such as 
the level of alcohol consumption and smoking). 
6.1.9 Patient and/or parent(s)/legal representative is willing to allow the responsible 
authorities to be notified of participation in the study, if mandated by local 
law.  


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6.1.10 Patient and/or parent(s)/legal representative is willing to allow his or her 
primary care practitioner and consultant (if they have one) to be notified of 
participation in the study, if mandated by local law. 
At the end of the baseline period, patients must also meet the following criteria: 
6.1.11 Experienced at least eight seizures during the first 28 days of the baseline 
period, with at least one seizure occurring in at least three of the four weeks 
(seizures include: focal motor seizures without impairment of consciousness 
or awareness; focal seizures with impairment of consciousness or awareness; 
focal seizures evolving to bilateral generalized convulsive seizures and 
generalized seizures ([tonic–clonic, tonic, clonic or atonic] that are countable).  
6.1.12 Completed at least 90% of calls to IVRS during the first 28 days of the 
baseline period (a minimum of 25 completed calls).  
6.2 
Exclusion Criteria 
The patient may not enter the study if ANY of the following apply: 
6.2.1 Patient has a history of pseudo-seizures. 
6.2.2 Patient has clinically significant unstable medical conditions other than 
epilepsy. 
6.2.3 Patient has an illness in the four weeks prior to screening or randomization, 
other than epilepsy, which in the opinion of the investigator could affect 
seizure frequency. 
6.2.4 Patient has undergone general anesthetic in the four weeks prior to screening 
or randomization. 
6.2.5 Patient has undergone surgery for epilepsy in the six months prior to 
screening. 
6.2.6 Patient is being considered for epilepsy surgery or any procedure involving 
general anesthesia during the blinded phase of the study. 
6.2.7 Patient has been taking felbamate for less than one year prior to screening. 
6.2.8 Patient is taking an oral mTOR inhibitor. 
6.2.9 Patient has, in the investigator’s opinion, clinically significantly abnormal 
laboratory values. 


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6.2.10 Patient has any known or suspected hypersensitivity to cannabinoids or any of 
the excipients of the IMP, such as sesame oil. 
6.2.11 Any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the 
C-SSRS in the last month or at screening. 
6.2.12 Patient is currently using or has in the past used recreational or medicinal 
cannabis, or cannabinoid-based medications, within the three months prior to 
screening and is unwilling to abstain for the duration for the study. 
6.2.13 Patient has tumor growth which, in the opinion of the investigator, could affect 
the primary endpoint. 
6.2.14 In the opinion of the investigator the patient has clinically significant 
abnormalities in the ECG measured at screening or randomization or any 
concurrent cardiovascular conditions, which will interfere with the ability to 
read their ECGs.  
6.2.15 Patient has significantly impaired hepatic function at the screening visit 
(Visit 1) or the randomization visit (Visit 3), defined as any of the following: 
i) Serum alanine aminotransferase (ALT) or aspartate aminotransferase 
(AST) > 5 × upper limit of normal (ULN). 
ii) TBL* [serum total bilirubin] ≥ 2 × ULN or international normalized ratio 
[INR] > 1.5 (*TBL ≥ 2 × ULN exclusion will not apply for patients 
diagnosed with Gilbert’s disease). 
iii) Serum ALT or AST ≥ 3 × ULN with the presence of fatigue, nausea, 
vomiting, right upper quadrant pain or tenderness, fever, rash, and/or 
eosinophilia (> 5%). 
This criterion can only be confirmed once the laboratory results are available.  
6.2.16 Patient is female and of child bearing potential, or is male whose partner is of 
child bearing potential, unless willing to ensure that they or their partner use a 
highly effective method of birth control (e.g., hormonal contraceptives, 
intrauterine devices/hormone-releasing systems, bilateral tubal occlusion, 
vasectomized partner, sexual abstinence) during the study and for three 
months thereafter. 
6.2.17 Female patient who is pregnant (positive pregnancy test), lactating or planning 
pregnancy during the course of the study and for three months thereafter. 
6.2.18 Patient has received an IMP less than 12 weeks prior to the screening visit. 


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6.2.19 Patient has any other significant disease or disorder which, in the opinion of 
the investigator, may either put the patient at risk because of participation in 
the study, may influence the result of the study, or may affect the patient’s 
ability to take part in the study. 
6.2.20 Any abnormalities identified following a physical examination of the patient 
that, in the opinion of the investigator, would jeopardize the safety of the 
patient if they take part in the study. 
6.2.21 Patient has donated blood during the past 12 weeks and is unwilling to abstain 
from donation of blood during the study. 
6.2.22 Patient has been previously randomized into this study. 
6.2.23 Patient has any known or suspected history of alcohol or substance abuse.  
6.2.24 Patient has travel outside the country and/or state of residence planned during 
the trial, unless the patient has confirmation that the IMP is permitted in the 
destination country/state. 


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SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol V8 23Apr19 
 
Confidential 
Page 63 of 154 
Template: 231014.V1 
 
8 
TREATMENT PROCEDURES 
8.1 
Investigational Medicinal Product Dosage, Administration and 
Schedule 
The use of placebo in the current study was deemed necessary to determine the 
efficacy and safety of the current intervention, since the best proven intervention had 
already been tried or may be given as an adjuvant treatment, failing to fully alleviate 
the patient’s symptoms.  For details regarding IMP formulations, see Section 5. 
Patients will be assigned to receive GWP42003-P 25 mg/kg/day, GWP42003-P 
50 mg/kg/day, placebo 25 mg/kg/day dose volume equivalent, or placebo 
50 mg/kg/day dose volume equivalent at a 2:2:1:1 ratio.  The placebo groups will be 
pooled for the analyses of efficacy.  
8.1.1 
Dose Administration 
The IMP will be administered by the patient or their caregiver twice each day 
(morning and evening) using the syringe(s) provided and may be taken with other 
concomitant medications, as directed by the investigator. 
Patients may not be randomized into the study if using a gastrostomy/nasogastric 
tube, unless the patient is able to still take medication orally.  Dosing through 
gastrostomy/nasogastric tubes may be allowed after consultation with the GW 
medical monitor.  Alteration in dosing frequency may also be considered after 
consultation with the GW medical monitor. 
8.1.2 
Dose Escalation and Dose Adjustments 
All patients will be weighed during Visit 3 and the daily volumes of IMP solution to 
be taken during the maximum four-week titration period and for the remainder of the 
blinded phase maintenance period will be calculated via the IVRS and the dosing 
regimen provided to the patient and/or caregiver.  Doses may be altered during the 
OLE according to changes in patient weight. Further information on dispensing 
procedures will be provided in a separate Pharmacy Manual.  
Titration from 0–25 mg/kg/day will begin at 5 mg/kg/day and will be increased in 
increments of 5 mg/kg/day every two days (patients will remain on each dose level for 
two days before they progress on to the next dose).  Titration from 25–50 mg/kg/day 
will continue at smaller increments of 2.5 mg/kg/day every two days.  


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Study Code: GWEP1521 
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Table 8.1.2-1 
Dose Titration Regimen* 
Day 
Dose Level 1  
(25 mg/kg/day) 
Dose Level 2  
(50 mg/kg/day) 
1 
5.0 mg/kg 
5.0 mg/kg 
2 
5.0 mg/kg 
5.0 mg/kg 
3 
10.0 mg/kg 
10.0 mg/kg 
4 
10.0 mg/kg 
10.0 mg/kg 
5 
15.0 mg/kg 
15.0 mg/kg 
6 
15.0 mg/kg 
15.0 mg/kg 
7 
20.0 mg/kg 
20.0 mg/kg 
8  
20.0 mg/kg 
20.0 mg/kg 
9 
25.0 mg/kg 
25.0 mg/kg 
10 
25.0 mg/kg 
25.0 mg/kg 
11  
25.0 mg/kg 
27.5 mg/kg 
12 
25.0 mg/kg 
27.5 mg/kg 
13 
25.0 mg/kg 
30.0 mg/kg 
14 
25.0 mg/kg 
30.0 mg/kg 
15 
25.0 mg/kg 
32.5 mg/kg 
16 
25.0 mg/kg 
32.5 mg/kg 
17 
25.0 mg/kg 
35.0 mg/kg 
18  
25.0 mg/kg 
35.0 mg/kg 
19 
25.0 mg/kg 
37.5 mg/kg 
20 
25.0 mg/kg 
37.5 mg/kg 
21 
25.0 mg/kg 
40.0 mg/kg 
22 
25.0 mg/kg 
40.0 mg/kg 
23 
25.0 mg/kg 
42.5 mg/kg 
24 
25.0 mg/kg 
42.5 mg/kg 
25 
25.0 mg/kg 
45.0 mg/kg 
26 
25.0 mg/kg 
45.0 mg/kg 
27 
25.0 mg/kg 
47.5 mg/kg 
28 
25.0 mg/kg 
47.5 mg/kg 
29 
25.0 mg/kg 
50.0 mg/kg 
* IMP is to be taken twice daily. Total daily doses are shown. 
Each patient will take their first dose of IMP at Visit 3 (Day 1) and their final 
maintenance dose of IMP at Visit 10 (Day 113).  If an unacceptable AE develops at 
any time during the titration period, dosing should initially be suspended or amended, 
at the investigator’s discretion, until the event has resolved.  During the maintenance 
period, patients should continue on a stable dosing regimen at the target Dose Level.  
If that dose becomes poorly tolerated or an AE occurs (e.g., somnolence, transaminase 
elevation not meeting withdrawal criteria specified in Section 10 and Section 12.8), 
the investigator may consider temporarily or permanently reducing the dosage for the 
remainder of the maintenance period following discussion with the GW medical 
monitor.  It is recommended that patients with poor tolerability have their daily dose 
reduced by 10 mg/kg every seven days unless, in the investigator’s opinion, smaller or 


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Study Code: GWEP1521 
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Protocol V8 23Apr19 
 
Confidential 
Page 65 of 154 
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larger or more rapid dose reductions are clinically indicated.  Where possible, the 
patient should be encouraged to return to the target Dose Level. 
Patients entering the OLE will first complete a two-week blinded transition phase. 
OLE IMP will be titrated up to 25 mg/kg/day whilst blinded IMP is simultaneously 
tapered down to zero.  All patients will complete the transition and enter the OLE 
taking 25 mg/kg/day GWP42003-P. 
Following completion of the blinded transition patients may complete a three-week 
titration up to a target dose of 50 mg/kg/day.   Beginning at 25 mg/kg/day the dose 
will increase in increments of 2.5 mg/kg/day every two days. 
Table 8.1.2-2 is an example of the OLE transition (Visit B1 to Visit B2) for patients 
transitioning from each group of the randomized phase.  
Table 8.1.2-2 
Blinded Transition 
Day Blinded 
Transition/OLE 
Patients randomized to 
25 mg/kg/day group 
Patients randomized to 
50 mg/kg/day group 
Patients randomized to 
placebo group 
Blinded 
Open-label 
Blinded 
Open-label 
Placebo 
Open-label 
1 
25 
0 
50 
0 
0 
0 
2 
22.5 
0 
45 
0 
0 
0 
3 
20 
5 
40 
5 
0 
5 
4 
17.5 
5 
35 
5 
0 
5 
5 
15 
10 
30 
10 
0 
10 
6 
12.5 
10 
25 
10 
0 
10 
7 
10 
15 
20 
15 
0 
15 
8 
7.5 
15 
15 
15 
0 
15 
9 
5 
20 
10 
20 
0 
20 
10 
2.5 
20 
5 
20 
0 
20 
11 
0 
25 
0 
25 
0 
25 
12 
0 
25 
0 
25 
0 
25 
13 
0 
25 
0 
25 
0 
25 
14 
0 
25 
0 
25 
0 
25 
 
Following completion of the blinded transition patients may complete a three-week 
titration up to a target dose of 50 mg/kg/day.  Beginning at 25 mg/kg/day the dose 
will increase in increments of 2.5 mg/kg/day every two days (Table 8.1.2-3). 
Table 8.1.2-3 
OLE Titration Schedule 
OLE Day 
Daily Dose 
(mg/kg/day) 
15 (Visit B2) 
26.25a 
16 
27.5 
17 
30 
18 
30 


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Study Code: GWEP1521 
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Protocol V8 23Apr19 
 
Confidential 
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Table 8.1.2-3 
OLE Titration Schedule 
OLE Day 
Daily Dose 
(mg/kg/day) 
19 
32.5 
20 
32.5 
21 
35 
22 
35 
23 
37.5 
24 
37.5 
25 
40 
26 
40 
27 
42.5 
28 
42.5 
29 
45 
30 
45 
31 
47.5 
32 
47.5 
33 
50 
34 
50 
35 
50 
36 (Visit B3) 
50 
a Derived from an AM dose based on 25 mg/kg/day and a PM dose based on 27.5 mg/kg/day. 
Patients who do not enter the OLE study at Visit 10 or withdraw early will have their 
dose of IMP tapered gradually (10% each day) over a period of 10 days unless 
continued dosing is not possible due to an AE.  Patients not entering the OLE will 
return used and unused IMP to the clinic at Visit 11. 
8.2 
Concomitant Therapy 
It is theoretically possible that GWP42003-P may modify the metabolism of other 
drugs (including AEDs) administered concurrently and there remains the possibility 
of pharmacological interactions between GWP42003-P and other concurrently 
administered drugs.  Doses of any concomitant AEDs must have been stable for at 
least four weeks prior to screening and must remain stable throughout the blinded 
study period.  If during the blinded or OLE phase plasma concentrations of 
concomitant AEDs are found to be altered following administration of IMP, or if there 
are side-effects suspected of being related to an elevation in the concomitant AED 
concentration, the investigator must contact the GW medical monitor to discuss best 
management.  Decisions should be based on clinical symptoms and not plasma levels 
of AEDs.  Further information on drug interactions can be found in the IB51. 
Concomitant AED dose reductions are permitted on clinical grounds (e.g., due to AEs 
or transaminase elevations not meeting withdrawal criteria specified in Section 10 
and Section 12.8) following discussion with the GW medical monitor. 


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Protocol V8 23Apr19 
 
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Additional new AEDs (including oral mTOR inhibitors) are not allowed to be added 
during the randomized phase of the trial but may be considered on a case-by-case 
basis for the OLE phase in accordance with local licensing and after consultation with 
the GW medical monitor. 
The use of rescue medication is allowed when necessary.  Any medication, other than 
the IMP, taken during the study must be recorded on the Case Report Form (CRF). 
Any non-pharmacological therapies (e.g., ketogenic diet, vagus nerve stimulation) 
must also be stable up to four weeks prior to screening and throughout the duration of 
the study. 
8.3 
Prohibited Therapy During Study Period 
The following medications are prohibited for the duration of the study beginning from 
acquisition of patient consent/assent.  However, any patients taking these medications 
after randomization should not be withdrawn from the study unless there are safety 
concerns.  If applicable, the possible effects of these medications on the primary 
endpoint will be considered during the assessment of the evaluable period (see 
Section 13.6.1). 
• Any new medications or interventions for epilepsy (including ketogenic diet 
and vagus nerve stimulation) or changes in dosage. 
• Recreational or medicinal cannabis or synthetic cannabinoid-based 
medications (including Sativex®). 
• Any other IMP taken as part of a clinical trial. 
Care should be taken with drugs, or their metabolites, that are cytochrome P450 2C19 
substrates, such as N-desmethylclobazam.  Care should also be taken with drugs, or 
their metabolites, that are solely or primarily metabolized by UDP-
glucuronosyltransferase 1A9 and 2B7. 
8.4 
Compliance in Investigational Medicinal Product Administration 
The IMP is dispensed to the patient at each of the following visits: 
• Visit 3 (Day 1) 
• Visit 4 (Day 15) 
• Visit 5 (Day 29) 
• Visit 6 (Day 43) 


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Study Code: GWEP1521 
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Protocol V8 23Apr19 
 
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• Visit 7 (Day 57) 
• Visit 9 (Day 85) 
• Visit 10 (Day113) (patients not entering the OLE) 
• All OLE visits until the end of treatment 
The patient or their caregiver will record the volume of solution taken on each 
treatment day in the diary. 
Patients should return all IMP (used and unused) at each of visits 4, 5, 6, 7, 9, 10 and 
11 during the blinded phase and at all OLE visits.  The usage recorded in the diary 
and the usage projected in the dose calculator will be checked and any discrepancies 
discussed with the patient or their caregiver at the time of the visit and documented 
accordingly within the patient’s source documents. 
Records of IMP accountability will be maintained according to Section 5.3.4. 
8.5 
Access to Blinded Treatment Assignment (Blinded Phase and 
OLE Transition Only) 
The identity of IMP assigned to patients will be held by the IVRS.  The principal 
investigator (PI) at each center, or his/her designee, is responsible for ensuring that 
information on how to access the IVRS for an individual patient is available to the 
relevant staff in case of an emergency and unblinding is required.  A patient’s 
treatment assignment should only be unblinded when knowledge of the treatment is 
essential to make a decision on the medical management of the patient.  Unblinding 
for any other reason will be considered a protocol deviation. 
The investigator is encouraged to contact GW to discuss the rationale for unblinding 
prior to doing so.  However, to prevent delays to the investigator or medical personnel 
responding to a potentially emergent situation, unblinding of study medication will 
not be dependent upon the investigator receiving approval from GW (i.e., the 
investigator will be able to obtain the code break information independent of 
contacting GW). 
If the investigator does unblind, they must contact GW within one working day of the 
event and must document the time, date and reason(s) for unblinding on the patient’s 
CRF. 


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Study Code: GWEP1521 
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9 
STUDY PROCEDURES 
A list of the required study procedures is provided in the subsections that follow; refer 
also to the Schedule of Assessments (APPENDIX 1).  Assessments or tests that are 
not done and examinations that are not conducted must be reported as such in the 
CRFs. 
The location of the source data for the following procedures will be documented, per 
center, in a signed ‘Source Data Verification’ plan; for further details see 
Section 16.2. 
9.1 
Study Procedures by Visit 
Patients and their parent(s)/legal representative will be invited to take part in the study 
and will be issued with the patient information and informed consent/assent or the 
patient/parent(s)/legal representative information and informed consent.  Following 
adequate time to discuss the study with the investigator, nurse, relatives or caregiver, 
as wished, patients/parent(s)/legal representatives who provide written informed 
consent/assent will be screened for entry into the study. 
9.1.1 
Blinded Phase 
9.1.1.1 
Visit 1 (Day −35, Screening) 
Eligibility must be assessed according to the criteria specified in Section 6. 
The following observations will be made at Visit 1: demographics, medical history 
(including seizure information since diagnosis, history of epilepsy-specific genetic 
testing and all prior AEDs taken), concomitant medications (including AEDs), 
physical examination (including height and body weight), ECG, vital signs, postural 
blood pressure and visit procedure-related AEs.  With the patient/parent(s)/legal 
representative’s consent, a further blood test will be carried out to determine the 
mutation status of TSC1 and TSC2, if it is unknown. 
The patient’s documented history of TSC will be sent to the ESC to confirm seizure 
classification.  
Clinical laboratory samples (blood and urine [where possible]), including pregnancy 
tests if appropriate (using both a serum sample and a urine dipstick), will be taken for 
hematology, biochemistry, urinalysis, and a urine/serum THC screen.  Suicidality will 
be assessed in accordance with Section 9.2.12.8. 


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The investigator must record the patient’s attendance at the visit and confirm the 
outcome of screening on the CRF. 
9.1.1.2 
Visit 2 (Day −28, Baseline) 
This visit will occur 7 days after Visit 1.  A visit window of ±7 days from the 
scheduled visit is permitted to ensure ESC confirmation of seizure classification, but 
it is preferred that the visit is performed on the scheduled visit day where possible. 
Attendance of the patient is not required for this visit provided the primary caregiver 
is able to attend and that this caregiver (not the patient) will be responsible for seizure 
identification, IVRS use, and paper diary completion.  However, it is preferred that 
the patient attend where possible.  
The following observations will be made at Visit 2: review of concomitant 
medications (including AEDs), AEs and epilepsy-related hospitalizations. 
Patients who satisfy all inclusion and none of the exclusion criteria specified in 
Section 6 will begin the 28 (+3)-day baseline period.  The investigator will review and 
train the patient or their caregiver to identify the patient’s expected seizure types.  
Patients or their caregivers will be issued with IVRS details and will be instructed on 
how to use it to record daily seizure information.  Patients or their caregivers will also 
be given a paper diary to record usage of IMP, rescue medication, concomitant AEDs 
and AEs and will be instructed on how to do so.  
9.1.1.3 
Visit 3 (Day 1, Randomization) 
This visit will occur 28 days after Visit 2.  A visit window of +3 days from the 
scheduled visit date is permitted, but it is preferred that the visit is performed on the 
scheduled visit day where possible. 
The following observations will be made at Visit 3: concomitant medications, 
(including AEDs), physical examination (including height and body weight), details 
of menstruation (for females), Tanner Staging (for patients aged 10–17 years 
[inclusive], or earlier if clinically indicated by onset of menarche or other signs of 
precocious puberty), ECG, vital signs, postural blood pressure, epilepsy-related 
hospitalizations, AEs and paper diary review.  The ECG will be repeated four hours 
(±30 minutes) after the first dose of IMP. 
Clinical laboratory samples (blood and urine [where possible]), including pregnancy 
tests if appropriate (using both a serum sample and a urine dipstick), will be taken for 
hematology, biochemistry, urinalysis, and determination of serum IGF-1 levels (for 


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patients less than 18 years of age).  Provided that the risk/benefit outcome is favorable 
in the investigator’s opinion, prior to the first daily dose of IMP, a blood sample will 
be taken for analysis of plasma concentrations of concomitant AEDs.  PK samples 
(patients > 20 kg in weight only) will be taken in accordance with Section 9.2.9.1.  
The investigator must assess the patient’s daily number of seizures from the patient’s 
IVRS data, record the patient’s attendance at the visit, and confirm the outcome of the 
visit prior to randomization.  Patients who have experienced at least eight seizures 
during the first 28 days of the baseline period, and who meet all of the other inclusion 
and none of the exclusion criteria specified in Section 6, will be eligible to continue in 
the study.  
Eligible patients will then be randomized to receive GWP42003-P 25 mg/kg/day, 
GWP42003-P 50 mg/kg/day, placebo 25 mg/kg/day dose volume equivalent, or 
placebo 50 mg/kg/day dose volume equivalent at a 2:2:1:1 ratio.  
Following randomization at Visit 3, patients will remain at the clinic where the 
following baseline assessments will be performed prior to the administration of study 
medication: QOLCE/QOLIE-31-P, Wechsler Tests, CBCL/ABCL, SCQ and the 
Vineland-II. Suicidality will be assessed in accordance with Section 9.2.12.8. 
Patients/caregivers and investigators will be asked to write a brief description of 
their/the patient’s overall condition and assess the average duration of seizure 
subtypes as a memory aid for the PGIC, SGIC/CGIC and SGIC-SD/CGIC-SD; these 
will be referred to at relevant, subsequent visits or withdrawal.  
IMP will be dispensed for the following 2 weeks and patients or their caregivers will 
be provided with individual dosing schedules as described in Section 8.1 Each patient 
will then receive a titration regimen.  The first dose of IMP will be administered in 
clinic. 
Following Visit 3, during titration, safety telephone calls must be made every two 
days.  If the call falls on a weekend, it is permitted to schedule the call for the Friday 
before or Monday after the weekend instead.  A further call must be completed one 
week after the end of titration.  During these calls, caregivers will be asked for 
information on AEs, epilepsy-related hospitalizations, concomitant medications 
and/or changes to medication.  The investigator must retain oversight of safety 
telephone calls. 


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9.1.1.4 
Visit 4 (Day 15) 
This visit will occur 14 days after Visit 3 (randomization).  A visit window of ±3 days 
from the scheduled visit date is permitted, but it is preferred that the visit is performed 
on the scheduled visit day where possible. 
The following observations will be made at Visit 4: concomitant medications, 
(including AEDs), physical examination (including height and body weight), ECG, 
vital signs, epilepsy-related hospitalizations and AEs. 
Clinical laboratory samples (blood and urine [where possible]) will be taken for 
hematology, biochemistry and urinalysis.  
Suicidality will be assessed in accordance with Section 9.2.12.8. 
The investigator must assess adherence to the titration regimen by reviewing the 
patient’s diary and IVRS data and record the patient’s attendance at the visit. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  Patients will then receive a new treatment pack of the IMP. 
Following Visit 4, during titration, safety telephone calls must be made every two 
days.  If the call falls on a weekend, it is permitted to schedule the call for the Friday 
before or Monday after the weekend instead.  During these calls, caregivers will be 
asked for information on AEs, epilepsy-related hospitalizations, concomitant 
medications and/or changes to medication.  The investigator must retain oversight of 
safety telephone calls. 
9.1.1.5 
Visit 5 (Day 29) 
This visit will occur 28 days after Visit 3.  A visit window of ±3 days from the 
scheduled visit date is permitted, but it is preferred that the visit is performed on the 
scheduled visit day where possible. 
The following observations will be made at Visit 5: concomitant medications, 
(including AEDs), physical examination (including height and body weight), ECG, 
vital signs, postural BP, epilepsy-related hospitalizations and AEs. 
Clinical laboratory samples (blood and urine [where possible]), including pregnancy 
tests if appropriate (using both a serum sample and a urine dipstick), will be taken for 
hematology, biochemistry and urinalysis.  Provided that the risk/benefit outcome is 
favorable in the investigator’s opinion, prior to the first daily dose of IMP, a blood 
sample will be taken for analysis of plasma concentrations of concomitant AEDs. 


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Suicidality will be assessed in accordance with Section 9.2.12.8. 
The investigator must assess adherence to the titration regimen by reviewing the 
patient’s diary and IVRS data and record the patient’s attendance at the visit. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  Patients will then receive a new treatment pack of the IMP. 
A safety telephone call must be made one week after the end of titration (Visit 5).  
During this call, caregivers will be asked for information on AEs, epilepsy-related 
hospitalizations, concomitant medications and/or changes to medication.  The 
investigator must retain oversight of the safety telephone call. 
9.1.1.6 
Visit 6 (Day 43) 
This visit will occur 42 days after Visit 3 (randomization).  A visit window of ±3 days 
from the scheduled visit date is permitted, but it is preferred that the visit is performed 
on the scheduled visit day where possible. 
The following observations will be made at Visit 6: concomitant medications, 
(including AEDs), physical examination (including height and body weight), ECG, 
vital signs, epilepsy-related hospitalizations and AEs. 
Clinical laboratory samples (blood and urine [where possible]) will be taken for 
hematology, biochemistry and urinalysis.  Suicidality will be assessed in accordance 
with Section 9.2.12.8. 
The investigator must assess adherence to the dosing regimen by reviewing the 
patient’s diary and IVRS data and record the patient’s attendance at the visit. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made. Patients will then receive new IMP. 
9.1.1.7 
Visit 7 (Day 57) 
This visit will occur 56 days after Visit 3 (randomization).  A visit window of ±3 days 
from the scheduled visit date is permitted, but it is preferred that the visit is performed 
on the scheduled visit day where possible. 
The following observations will be made at Visit 7: concomitant medications 
(including AEDs), physical examination (including height and body weight), ECG, 
vital signs, epilepsy-related hospitalizations and AEs. 


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Clinical laboratory samples (blood and urine [where possible]), including pregnancy 
tests if appropriate (using both a serum sample and a urine dipstick), will be taken for 
hematology, biochemistry and urinalysis.  Provided that the risk/benefit outcome is 
favorable in the investigator’s opinion, prior to the first daily dose of IMP, a blood 
sample will be taken for analysis of plasma concentrations of concomitant AEDs. 
Suicidality will be assessed in accordance with Section 9.2.12.8. 
The investigator must assess adherence to the dosing regimen by reviewing the 
patient’s diary and IVRS data and record the patient’s attendance at the visit. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  Patients will then receive new IMP. 
9.1.1.8 
Visit 8 (Day 71) 
This visit will occur 70 days after Visit 3 (randomization).  A visit window of ±3 days 
from the scheduled visit date is permitted, but it is preferred that the visit is performed 
on the scheduled visit day where possible. 
Visit 8 will be completed by telephone and will comprise a review of concomitant 
medications (including AEDs), epilepsy-related hospitalizations and AEs. 
9.1.1.9 
Visit 9 (Day 85) 
This visit will occur 84 days after Visit 3 (randomization).  A visit window of ±3 days 
from the scheduled visit date is permitted, but it is preferred that the visit is performed 
on the scheduled visit day where possible. 
The following observations will be made at Visit 9: concomitant medications 
(including AEDs), physical examination (including height and body weight), ECG, 
vital signs, epilepsy-related hospitalizations and AEs. 
Clinical laboratory samples (blood and urine [where possible]), including pregnancy 
tests if appropriate (using both a serum sample and a urine dipstick), will be taken for 
hematology, biochemistry and urinalysis.  Provided that the risk/benefit outcome is 
favorable in the investigator’s opinion, prior to the first daily dose of IMP, a blood 
sample will be taken for analysis of plasma concentrations of concomitant AEDs. 
Suicidality will be assessed in accordance with Section 9.2.12.8. 
The investigator must assess adherence to the dosing regimen by reviewing the 
patient’s diary and IVRS data and record the patient’s attendance at the visit. 


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All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  Patients will then receive new IMP. 
9.1.1.10 
Visit 10 (Day 113, End of Treatment/Withdrawal Visit) 
This visit will occur 112 days after Visit 3 (randomization) or earlier if the subject 
withdraws from the study.  A visit window of ±3 days from the scheduled visit date is 
permitted, but it is preferred that the visit is performed on the scheduled visit day 
where possible.  Patients will be instructed to record the dosing time of their 
concomitant AEDs in the diary. 
The following observations will be made at Visit 10/the Withdrawal visit: 
concomitant medications (including AEDs), physical examination (including height 
and body weight), Tanner Staging (for patients aged 10–17 years [inclusive], or 
earlier if clinically indicated by onset of menarche or other signs of precocious 
puberty), details of menstruation (for females), ECG, vital signs, epilepsy-related 
hospitalizations and AEs. 
Clinical laboratory samples (blood and urine [where possible]), including pregnancy 
tests if appropriate (using both a serum sample and a urine dipstick), will be taken for 
hematology, biochemistry, urinalysis, and determination of serum IGF-1 levels (for 
patients less than 18 years of age) to be performed by the central laboratory.  Provided 
that the risk/benefit outcome is favorable in the investigator’s opinion, prior to the 
first daily dose of IMP, a blood sample will be taken for analysis of plasma 
concentrations of concomitant AEDs. PK samples (patients > 20 kg in weight only) 
will be taken in accordance with Section 9.2.9.1. 
The following assessments will also be performed: QOLCE/QOLIE-31-P, PGIC, 
SGIC/CGIC, SGIC-SD/CGIC-SD, Wechsler Tests, CBCL/ABCL, SCQ and the 
Vineland-II.  Suicidality will be assessed in accordance with Section 9.2.12.8. 
The investigator must assess adherence to the dosing regimen by reviewing the 
patient’s diary and IVRS data, record the patient’s attendance at the visit and confirm 
the outcome of the visit. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made. 
For patients 12 years of age and older who do not enter the taper period, the trained 
investigator or study coordinator will complete the Study Medication Use and 
Behavior Survey as an interview with the patient/caregiver. 


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For patients who withdraw early, the IVRS will be contacted to confirm withdrawal 
from the study.  Patients who withdraw should have their dose of IMP tapered 
gradually (10% each day) over a period of 10 days, beginning at the time the decision 
is made to discontinue.  In some cases, tapering the dose of IMP may be inadvisable 
(e.g., continued dosing is not possible due to an AE).  The decision on whether or not 
to taper IMP will be left to the investigator’s clinical judgment.  If tapering is 
undertaken, a 10-day supply of IMP (if required) and instructions for tapering the 
dose will be provided.  Patients/caregivers should continue to complete the IVRS (see 
APPENDIX 4) and paper diary and should return for Visit 11 (the ‘End of Taper 
Period’ visit), if possible. 
Patients who have completed all of the scheduled study visits will be offered the 
option of entering an OLE. Entry is to be on the same day as Visit 10 (Day 113).  
Patients not entering the OLE at this visit will be given a 10-day supply of IMP (if 
required) and instructions for tapering the dose, during which time IVRS (see 
APPENDIX 4) and paper diary information will continue to be recorded. 
9.1.1.11 
Visit 11 (Day 123, End of Taper) 
This visit is required only for those patients who do not enter the OLE on the day of 
Visit 10 or for those who withdraw early and taper IMP.  For patients who complete 
the study but opt not to enter the OLE, Visit 11 should occur 10 (+3) days after 
Visit 10 (i.e., on Day 123 [+3]).  For patients who withdraw early and taper IMP, this 
visit should occur 10 (+3) days after the Withdrawal visit.  For patients who begin to 
taper IMP but subsequently withdraw/do not complete the full taper period, this visit 
should occur on the final day of dosing or as soon as possible after this date. 
The following observations will be made at Visit 11: concomitant medications 
(including AEDs), epilepsy-related hospitalizations and AEs, physical examination 
(including height and body weight), vital signs, ECG and clinical laboratory samples 
(blood and urine for hematology, biochemistry and urinalysis).  Suicidality will be 
assessed in accordance with Section 9.2.12.8.  
For patients 12 years of age and older, the trained investigator or study coordinator 
will complete the Study Medication Use and Behavior Survey as an interview with 
the patient/caregiver. 
The investigator must assess adherence to the dosing regimen by reviewing the 
patient’s diary and IVRS data and record the patient’s attendance at the visit. 


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All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made. The patient diaries will be collected. 
Following Visit 11 (or date of final dosing) the IVRS seizure reporting diary should 
only be completed once more (see APPENDIX 4). 
9.1.1.12 
Visit 12 (Day 151, Safety Follow-up) 
This visit is required for patients who do not enter the OLE or who withdraw from the 
study early.  This visit should occur four weeks after Visit 11 (+3 days), or date of 
final dosing, and can be conducted over the telephone.  The following observations 
will be made at Visit 12: concomitant medications (including AEDs), epilepsy-related 
hospitalizations and AEs.  
9.1.2 
Open-label Extension 
Patients who successfully complete the blinded phase will be invited to participate in 
the OLE when they reach the End of Treatment visit (Visit 10) of the blinded phase.  
They will be issued with the OLE patient information and informed assent or the 
patient/parent(s)/legal representative information and informed consent (as 
applicable).  Following adequate time to discuss the study with the investigator, nurse, 
relatives or caregiver, patients/parent(s)/legal representatives who provide written 
informed consent/assent at Visit B1 will be enrolled into the OLE.  The OLE period 
will last for a maximum of 1 year; however, patients in the US and Poland may have 
the opportunity to continue in the OLE beyond this. 
On-label use of mTOR inhibitors (for the treatment of seizures or tumors) and general 
anesthesia are permitted in the OLE phase of the trial. 
9.1.2.1 
Visit B1 (Day 1) 
Day 1 is regarded as the first day of IMP dosing.  The following data collected at the 
‘End of Treatment’ visit of the blinded phase will also be considered as Visit B1 data: 
vital signs, physical examination (including height and body weight), details of 
menstruation (for females), Tanner Staging (patients aged 10–17 [inclusive]), ECG, 
clinical laboratory samples (blood and urine for hematology, biochemistry, urinalysis, 
determination of serum IGF-1 levels [patients less than 18 years of age], and 
pregnancy tests [if appropriate]), IVRS and paper diary information from the blinded 
phase (including information regarding seizures, AEs, usage of rescue medication, 
concomitant AEDs, IMP dosing), epilepsy-related hospitalizations, AEs, concomitant 
medications and/or changes to medication, QOLCE/QOLIE-31-P, PGIC, 


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SGIC/CGIC, SGIC-SD/CGIC-SD, Wechsler Tests, CBCL/ABCL, SCQ and the 
Vineland-II.  Suicidality will be assessed in accordance with Section 9.2.12.8. 
Patients will take their final dose of the blinded phase IMP in the morning of Visit B1, 
followed by collection of the blinded phase ‘End of Treatment’ assessments.  Patients 
will be instructed to begin the Blinded Open-label transition, taking their first dose of 
Blinded Transition OLE IMP in the evening of Visit B1 (Day 1). 
Patients or their caregivers will receive sufficient IMP for two weeks’ home dosing 
together with a blinded transition phase.  If an unacceptable AE develops at any time 
during transition, dosing should initially be suspended or amended, at the 
investigator’s discretion, until the event has resolved or is well tolerated. 
Patients or their caregivers will be given a paper diary to record information regarding 
AEs, IMP, usage of rescue medication, concomitant AEDs and IMP dosing.  In 
addition, patients/caregivers will be instructed to complete a weekly seizure reporting 
diary until the Follow-up visit using the IVRS. 
The investigator should review the laboratory results as soon as these become 
available.  If the results raise any safety concerns, the investigator should consider 
whether it will be appropriate for the patient to continue to participate in the extension 
study, or if the patient should be withdrawn. 
In order to complete the SGIC/CGIC, the patient/caregiver is to compare to the 
memory aid from the Baseline of the blinded phase.  If the memory aid is not 
available from the Baseline of the blinded phase then the patient/caregiver should do 
this from memory, if possible, and complete a memory aid at Visit B1. 
In order to complete the SGIC-SD/CGIC-SD, the patient/caregiver would have been 
asked to assess and note the average duration of the patient’s seizures at the Baseline 
of the blinded phase as a memory aid for subsequent visits.  If the memory aid is not 
available from the Baseline of the blinded phase then the patient/caregiver should do 
this from memory, if possible, and complete a memory aid at Visit B1. 
Following Visit B1, during the blinded transition, safety telephone calls must be made 
every two days.  If the call falls on a weekend, it is permitted to schedule the call for 
the Friday before or Monday after the weekend instead.  During these calls, caregivers 
will be asked for information on AEs, epilepsy-related hospitalizations, concomitant 
medications and/or changes to medication.  The investigator must retain oversight of 
safety telephone calls. 


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9.1.2.2 
Visit B2 (Day 15) 
Visit B2 will take place 14 days after Visit B1. A visit window of ±3 days from the 
scheduled visit date is permitted, but it is preferred that the visit is performed on the 
scheduled visit day where possible. 
The following assessments will be made at Visit B2: concomitant medications 
(including AEDs), physical examination (including height and body weight), ECG, 
vital signs, epilepsy-related hospitalizations, and AEs.  Clinical laboratory samples 
(blood and urine [where possible]) will be taken for hematology, biochemistry and 
urinalysis.  Provided that the risk/benefit outcome is favorable in the investigator’s 
opinion, prior to the first daily dose of IMP, a blood sample will be taken for analysis 
of plasma concentrations of concomitant AEDs.  Suicidality will be assessed in 
accordance with Section 9.2.12.8. 
The investigator must assess adherence to the titration regimen by reviewing the 
patient’s diary and IVRS data and record the patient’s attendance at the visit. 
Upon completion of the two-week blinded transition at Visit B2 all patients will be 
taking 25 mg/kg/day.  All blinded IMP (used and unused) will be collected and a 
check of the returned IMP against usage should be made.  Patients/caregivers will 
then receive sufficient open-label IMP for three weeks’ home dosing together with a 
titration schedule.  Patients may titrate up to the target dose of 50 mg/kg/day 
according to the defined titration schedule.  If an unacceptable AE develops at any 
time during titration, dosing should initially be suspended or amended, at the 
investigator’s discretion, until the event has resolved or is well tolerated. 
Following Visit B2, during titration, safety telephone calls must be made every two 
days.  If the call falls on a weekend, it is permitted to schedule the call for the Friday 
before or Monday after the weekend instead.  An additional call should be completed 
one week after the end of titration.  During these calls, caregivers will be asked for 
information on AEs, epilepsy-related hospitalizations, concomitant medications 
and/or changes to medication.  The investigator must retain oversight of safety 
telephone calls. 
9.1.2.3 
Visit B3 (Day 36) 
Visit B3 will take place 35 days after Visit B1.  A visit window of ±3 days from the 
scheduled visit date is permitted, but it is preferred that the visit is performed on the 
scheduled visit day where possible. 


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The following assessments will be made at Visit B3: concomitant medications 
(including AEDs), physical examination (including height and body weight), ECG, 
vital signs, postural blood pressure, epilepsy-related hospitalizations, and AEs. 
Suicidality will be assessed in accordance with Section 9.2.12.8.  Clinical laboratory 
samples (blood and urine [where possible]) will be taken for hematology, 
biochemistry and urinalysis.  Provided that the risk/benefit outcome is favorable in the 
investigator’s opinion, prior to the first daily dose of IMP, a blood sample will be 
taken for analysis of plasma concentrations of concomitant AEDs. 
The investigator must assess adherence to the titration regimen by reviewing the 
patient’s diary and IVRS data and record the patient’s attendance at the visit. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  Patients/caregivers will then receive sufficient open-label IMP 
for eight weeks’ home dosing. 
9.1.2.4 
Visit B4 (Day 92) 
This visit will occur 91 days after Visit B1. A visit window of ±3 days from the 
scheduled visit date is permitted, but it is preferred that the visit is performed on the 
scheduled visit day where possible.  
The following observations will be made at Visit B4: concomitant medications, 
(including AEDs), physical examination (including height and body weight), ECG, 
vital signs, epilepsy-related hospitalizations and AEs. 
Clinical laboratory samples (blood and urine [where possible]), including pregnancy 
tests if appropriate (using both a serum sample and a urine dipstick), will be taken for 
hematology, biochemistry and urinalysis to be performed by the central laboratory.  
Provided that the risk/benefit outcome is favorable in the investigator’s opinion, prior 
to the first daily dose of IMP, a blood sample will be taken for analysis of plasma 
concentrations of concomitant AEDs. 
The following assessments will also be performed: SGIC-SD/CGIC-SD. Suicidality 
will be assessed in accordance with Section 9.2.12.8. 
The investigator must assess adherence to the dosing regimen by reviewing the 
patient’s diary and IVRS data, record the patient’s attendance at the visit and confirm 
the outcome of the visit. 


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All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  Patients/caregivers will then receive sufficient open-label IMP 
until the next scheduled visit. 
9.1.2.5 
Visit B5 (Day 141, Re-supply Visit) 
This visit will occur 140 days after Visit B1.  A visit window of ±7 days from the 
scheduled visit date is permitted, but it is preferred that the visit is performed on the 
scheduled visit day where possible.  
Attendance of the patient is not required for this re-supply visit provided the primary 
caregiver is able to attend.  However, it is preferred that the patient attend where 
possible.  
The visit will comprise a review of concomitant medications (including AEDs), 
epilepsy-related hospitalizations and AEs. 
The investigator must assess adherence to the dosing regimen by reviewing the 
patient’s diary and IVRS data, record the patient’s/caregiver’s attendance at the visit 
and confirm the outcome of the visit. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  Patients/caregivers will then receive sufficient IMP until the 
next scheduled visit. 
9.1.2.6 
Visit B6 (Day 183) 
This visit will occur 182 days after Visit B1.  A visit window of ±7 days from the 
scheduled visit date is permitted, but it is preferred that the visit is performed on the 
scheduled visit day where possible.  
The following observations will be made at Visit B6: concomitant medications, 
(including AEDs), physical examination (including height and body weight), ECG, 
vital signs, epilepsy-related hospitalizations and AEs. 
Clinical laboratory samples (blood and urine [where possible]), including pregnancy 
tests if appropriate (using both a serum sample and a urine dipstick), will be taken for 
hematology, biochemistry, urinalysis and determination of serum IGF-1 levels (for 
patients less than 18 years of age) to be performed by the central laboratory.  Provided 
that the risk/benefit outcome is favorable in the investigator’s opinion, prior to the 
first daily dose of IMP, a blood sample will be taken for analysis of plasma 
concentrations of concomitant AEDs. 


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The following assessments will also be performed: QOLCE/QOLIE-31-P, PGIC, 
SGIC/CGIC, SGIC-SD/CGIC-SD, Wechsler Tests, CBCL/ABCL, SCQ and the 
Vineland-II. Suicidality will be assessed in accordance with Section 9.2.12.8. 
The investigator must assess adherence to the dosing regimen by reviewing the 
patient’s diary and IVRS data, record the patient’s attendance at the visit and confirm 
the outcome of the visit. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  Patients/caregivers will then receive sufficient open-label IMP 
until the next scheduled visit. 
9.1.2.7 
Visit B7 (Day 232, Re-supply Visit) 
This visit will occur 231 days after Visit B1.  A visit window of ±7 days from the 
scheduled visit date is permitted, but it is preferred that the visit is performed on the 
scheduled visit day where possible.  
Attendance of the patient is not required for this re-supply visit provided the primary 
caregiver is able to attend.  However, it is preferred that the patient attend where 
possible. 
The visits will comprise a review of concomitant medications (including AEDs), 
epilepsy-related hospitalizations and AEs. 
The investigator must assess adherence to the dosing regimen by reviewing the 
patient’s diary and IVRS data, record the patient’s/caregiver’s attendance at the visit 
and confirm the outcome of the visit. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  Patients/caregivers will then receive sufficient IMP until the 
next scheduled visit. 
9.1.2.8 
Visit B8 (Day 274) 
This visit will occur 273 days after Visit B1.  A visit window of ±7 days from the 
scheduled visit date is permitted, but it is preferred that the visit is performed on the 
scheduled visit day where possible.  
The following observations will be made at Visit B8: concomitant medications, 
(including AEDs), physical examination (including height and body weight), ECG, 
vital signs, epilepsy-related hospitalizations and AEs. 


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Clinical laboratory samples (blood and urine [where possible]), including pregnancy 
tests if appropriate (using both a serum sample and a urine dipstick), will be taken for 
hematology, biochemistry and urinalysis to be performed by the central laboratory.  
Provided that the risk/benefit outcome is favorable in the investigator’s opinion, prior 
to the first daily dose of IMP, a blood sample will be taken for analysis of plasma 
concentrations of concomitant AEDs. 
The following assessments will also be performed: SGIC-SD/CGIC-SD.  Suicidality 
will be assessed in accordance with Section 9.2.12.8. 
The investigator must assess adherence to the dosing regimen by reviewing the 
patient’s diary and IVRS data, record the patient’s attendance at the visit and confirm 
the outcome of the visit. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  Patients/caregivers will then receive sufficient open-label IMP 
until the next scheduled visit. 
9.1.2.9 
Visit B9 (Day 323, Re-supply Visit) 
This visit will occur 322 days after Visit B1.  A visit window of ±7 days from the 
scheduled visit date is permitted, but it is preferred that the visit is performed on the 
scheduled visit day where possible.  
Attendance of the patient is not required for this re-supply visit provided the primary 
caregiver is able to attend.  However, it is preferred that the patient attend where 
possible. 
The visits will comprise a review of concomitant medications (including AEDs), 
epilepsy-related hospitalizations and AEs. 
The investigator must assess adherence to the dosing regimen by reviewing the 
patient’s diary and IVRS data, record the patient’s/caregiver’s attendance at the visit 
and confirm the outcome of the visit. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  Patients/caregivers will then receive sufficient IMP until the 
next scheduled visit. 
Patients in the US and Poland may have the opportunity to continue in the OLE 
beyond Visit B10. Please refer to Protocol Annex 1 (US based patients) or Protocol 
Annex 2 (Poland based patients) for the remaining visit schedule. 


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9.1.2.10 
Visit B10 (Day 365, End of Treatment/Withdrawal Visit) 
This visit will occur 364 days after Visit B1or following early withdrawal from the 
study.  A visit window of ±7 days from the scheduled visit date is permitted, but it is 
preferred that the visit is performed on the scheduled visit day where possible.  The 
following assessments will be made at the ‘End of Treatment’/Withdrawal visit: vital 
signs, physical examination (including height and body weight), details of 
menstruation (for females), Tanner Staging (patients aged 10–17 [inclusive]), ECG, 
clinical laboratory samples (blood and urine for hematology, biochemistry, urinalysis, 
determination of serum IGF-1 levels [patients less than 18 years of age] and 
pregnancy tests if appropriate [using both a serum sample and a urine dipstick]), 
IVRS and paper diary information (including information regarding seizures, AEs, 
usage of rescue medication, concomitant AEDs, IMP dosing), epilepsy-related 
hospitalizations, concomitant medications and/or changes to medication, AEs, 
QOLCE/QOLIE-31-P, SGIC/CGIC, PGIC, SGIC-SD/CGIC-SD, Wechsler Tests, 
CBCL/ABCL, SCQ and the Vineland-II.  Suicidality will be assessed in accordance 
with Section 9.2.12.8.  Provided that the risk/benefit outcome is favorable in the 
investigator’s opinion, a blood sample will be taken for analysis of plasma 
concentrations of concomitant AEDs.  The investigator must assess adherence to the 
dosing regimen.  
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  For patients who withdraw early, the IVRS will be contacted 
to confirm withdrawal from the study.  For patients who immediately continue to use 
GWP42003-P following the ‘End of Treatment’ visit outside of the GWEP1521 study, 
the IVRS will be contacted to confirm the patient’s completion of this study and the 
paper diaries will be collected. 
For patients who do not immediately continue to use GWP42003-P following the 
‘End of Treatment’ visit outside of the GWEP1521 study, IMP will be tapered at 
home (10% per day for 10 days).  Additional IMP will be dispensed, if required, and 
instructions for tapering the dose will be provided. Patients who withdraw early 
should also begin the taper period following the Withdrawal visit (unless continued 
dosing is not possible due to an AE). Information will continue to be recorded in the 
paper diary during the taper period. 
For patients 12 years of age and older who do not enter the taper period, the trained 
investigator or study coordinator will complete the Study Medication Use and 
Behavior Survey as an interview with the patient/caregiver. 


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Following the End of Treatment/Withdrawal visit, the IVRS seizure reporting diary 
should be completed according to APPENDIX 4. 
For patients in the US and Poland who continue in the OLE beyond Visit B10, 
assessments are described in Protocol Annex 1 (US) and Protocol Annex 2 (Poland).  
9.1.2.11 
Visit B11 (Day 375, End of Taper Period Visit) 
This visit will take place 10 (+3) days after the ‘End of Treatment’ visit or 
Withdrawal visit for patients who withdraw early and taper IMP. For patients who 
begin to taper IMP but subsequently withdraw/do not complete the full taper period, 
this visit should occur on the final day of dosing or as soon as possible after this date. 
The following assessments will be made: concomitant medications (including AEDs), 
physical examination (including height and body weight), ECG, vital signs, 
epilepsy-related hospitalizations, and AEs. Clinical laboratory samples (blood and 
urine [where possible]) will be taken for hematology, biochemistry, and urinalysis. 
Suicidality will be assessed in accordance with Section 9.2.12.8.  The investigator 
must assess adherence to the dosing regimen by reviewing the patient’s diary and 
IVRS data and record the patient’s attendance at the visit. 
For patients 12 years of age and older, the trained investigator or study coordinator 
will complete the Study Medication Use and Behavior Survey as an interview with 
the patient/caregiver. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  
Following Visit B11 (or date of final dosing), the IVRS seizure reporting diary should 
only be completed once more (see APPENDIX 4). 
9.1.2.12 
B12 (Day 389, Post-taper Safety Telephone Call) 
A safety telephone call must be made two weeks (±3 days) after the ‘End of Taper 
Period’ visit or date of final dosing.  Patients or their caregivers will be asked for 
information on AEs, epilepsy-related hospitalizations, concomitant medications 
and/or changes to medication.  
Following this call, the IVRS seizure reporting diary should be completed up to the 
Follow-up visit. 


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9.1.2.13 
Follow-up Visit 
This visit is required for patients who withdraw from the study or complete treatment 
but do not wish to continue to use GWP42003-P.  The Follow-up visit will be 
performed four weeks (+3 days) after the patient’s last dose of GWP42003-P 
(including final taper period dose) and can be conducted over the telephone.  During 
this visit/call, caregivers will be asked for information on AEs, epilepsy-related 
hospitalizations, concomitant medications and/or changes to medication.  
9.1.2.14 
Safety Telephone Calls 
Safety telephone calls must be made every two days during the two-week blinded 
transition and the two-week OLE titration period and one week after the end of 
titration to assess AEs, epilepsy-related hospitalizations, concomitant medications 
and/or changes to medication.  If the call falls on a weekend, it is permitted to 
schedule the call for the Friday before or Monday after the weekend instead. 
The investigator must retain oversight of safety telephone calls. 
9.2 
Study Procedure Listing 
9.2.1 
Informed Consent/Assent 
Adult patients with an adequate level of understanding must personally sign and date 
the EC/IRB-approved / ICF before any study-specific procedures are performed or 
any patient-related data are recorded for the study. For adult patients with an 
insufficient level of understanding of what is proposed, only parent(s)/legal 
representative consent will be sought.  If an adult patient is unable to read (illiterate or 
visually impaired), or is physically unable to speak or write, an impartial witness 
should be present during the entire informed consent discussion.  After the ICF is read 
and explained to the patient and after the patient has orally consented to participation 
in the trial and has signed and dated the ICF (if capable of doing so), the witness 
should also sign and personally date the ICF.  By signing the ICF, the witness attests 
that the information in the ICF was accurately explained to and apparently understood 
by the patient and that informed consent was freely given by the patient (as outlined 
in the International Council for Harmonisation [ICH] Tripartite Guideline for GCP 
Topic E6(R2)52, section 4.8.9). 
The parent(s)/legal representative of minor patients must personally sign and date the 
EC/IRB-approved ICF before any study-specific procedures are performed or any 
patient-related data is recorded for the study.  In addition, in cases where the patient 


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possesses adequate understanding, assent will be taken (if allowed per local 
regulations) along with parent(s)/legal representative consent, using 
EC/IRB-approved assent forms.  Assent is defined as the minor’s permission or 
affirmative agreement to participate in the study.  The explicit wish of a minor, who is 
capable of forming an opinion and assessing the information provided, to refuse 
participation in or to be withdrawn from the clinical trial at any time must be 
considered by the investigator. 
For patients who go from being a minor to an adult (as per the country or state’s 
age-of-majority regulation) during the course of the study, a new ICF will be signed if 
the patient possesses adequate understanding to do so. 
If the patient cannot write, they can give consent/assent by “making their mark” on 
the consent/assent form (e.g., writing an “X”). 
GW requires a physician to be present for consent and assent and to sign the consent 
and assent forms also.  Patients/parent(s)/legal representatives will be given the option 
of being informed about the summary outcome and results of the trial as part of the 
ICF. For further details, see Section 15.2. 
9.2.2 
Contraception Requirements 
To be eligible for the study, the patient must have agreed that if they or their partner 
are of childbearing potential they are willing to use highly effective contraception for 
the duration of the study and for three months thereafter.  Highly effective methods of 
birth control are defined as those, alone or in combination, that result in a low failure 
rate (i.e., less than 1% per year) when used consistently and correctly53.  Such 
methods include hormonal contraceptives, intrauterine devices/hormone-releasing 
systems, bilateral tubal occlusion, vasectomized partner (provided that partner is the 
sole sexual partner of the trial patient and that the vasectomized partner has received 
medical assessment of the surgical success), or sexual abstinence54.  Abstinence, as 
referenced above, is only acceptable as true abstinence: when this is in line with the 
preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, 
ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable 
methods of contraception54. 


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9.2.3 
Demographics 
Patient demographics will be recorded at Visit 1.  The following information will be 
obtained for each patient: date of birth, sex and ethnic origin (if allowed per local 
regulations). 
9.2.4 
Medical History 
Relevant, significant medical history (including seizure information since diagnosis, 
history of epilepsy-specific genetic testing and all prior AEDs taken) will be obtained 
during Visit 1 and is defined as any condition or disease that: 
• May affect the condition under study. 
• Is ongoing on entry into the study. 
• Has occurred within one year prior to screening (Visit 1). 
The mutation status of the TSC1 and TSC2 genes, if known, will be obtained through 
the patient’s medical records. 
9.2.5 
Concomitant Medication 
Details of all current and recent medication (i.e., taken within the previous 14 days) 
including AEDs will be recorded at the screening visit (Visit 1) and reviewed at each 
subsequent visit.  AEDs used during the study should be maintained at a stable dose.  
Any changes in concomitant medication during the study must be recorded in the 
CRF at study visits.  Patients should stop taking any prohibited therapy prior to 
enrollment, as defined in Section 8.2. 
9.2.6 
Physical Examination 
A physical examination will be performed at the screening visit (Visit 1) to ensure 
that the patient is eligible to enter the study.  To ensure patient safety, further physical 
examinations will be performed during subsequent visits.  Physical examinations will 
include height and body weight measurements. 
9.2.7 
Vital Signs and Blood Pressure 
Vital sign measurements (body temperature, pulse rate, respiration rate), including 
blood pressure taken in a sitting position at rest for five minutes, will be completed 
alongside the physical examination.  Where postural blood pressure is required it 
should be measured after five minutes in supine position followed by two minutes in 


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standing position, if it is possible for the patient to stand.  Blood pressure must be 
recorded using the same arm throughout the study, where possible. 
9.2.8 
12-Lead Electrocardiogram 
A 12-lead ECG will be performed after five minutes in a supine position, if possible.  
A physician must review the ECG and any abnormal findings considered to indicate 
significant medical history or AEs must be recorded appropriately in the CRF. 
Additional ECG measurements can be taken at any time during the study, if clinically 
indicated. 
9.2.9 
Clinical Laboratory Sampling 
Laboratory tests will include hematology, biochemistry, urinalysis (provided urine 
can be obtained), urine/serum THC screening and a serum pregnancy test (if 
appropriate).  In addition to serum pregnancy tests, urine dipstick pregnancy tests will 
also be performed (if appropriate) at the study center.  Analysis of all clinical blood 
samples, pregnancy tests (using serum) and tests to detect the presence of THC will be 
conducted at a central clinical laboratory. 
Urine samples for biochemistry will be analyzed at the study center by use of a 
dipstick with any relevant findings being sent for further urinalysis at the central 
laboratory (urinalysis, microscopy, culture and sensitivity, as applicable).  In cases 
where urine samples cannot be analyzed at center due to local regulations, a full set of 
urine samples should be sent to the central laboratory for analysis.  Sample volume 
requirements and processing procedures will be detailed in a separate laboratory 
manual. 
The investigator and study monitor will be provided with a list of the normal ranges 
used by the testing laboratory for all variables assayed during the study and a 
statement of accreditation (or similar) for the laboratory.  Clinical laboratory sample 
parameters are detailed in Table 9.2.9-1. 


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Table 9.2.9-1 
Biochemistry, Hematology, Urinalysis and THC Screen 
Biochemistry 
(Serum)1 
Biochemistry 
(Serum)1,3 
Hematology 
(Whole Blood)1 
Urinalysis 
(Urine)2 
Pregnancy 
Test 
(Serum1 / 
Urine2) 
THC 
Screen 
(Serum1 / 
Urine1) 
Alanine 
aminotransferase 
(ALT) 
Insulin-like 
growth factor-1 
(IGF-1) 
Hematocrit 
Bilirubin 
Serum and 
urine 
THC 
Albumin 
 
Hemoglobin 
Blood 
 
 
Alkaline 
phosphatase 
 
Mean cell 
volume 
Glucose 
 
 
Aspartate 
aminotransferase 
(AST) 
 
Mean 
corpuscular 
hemoglobin 
Ketones 
 
 
Calcium 
 
Platelets 
Nitrites 
 
 
Creatinine 
 
Red blood cell 
count 
pH 
 
 
Estimates of 
glomerular 
filtration rate 
 
White blood cell 
count with 
automated 
differential 
Protein 
 
 
Gamma-glutamyl 
transferase 
 
 
Specific 
gravity 
 
 
Glucose 
 
 
Urobilinogen 
 
 
HDL-cholesterol 
 
 
 
 
 
Potassium 
 
 
 
 
 
Prolactin 
 
 
 
 
 
Prothrombin time 
(PT/INR) 
(plasma) 
 
 
 
 
 
Sodium 
 
 
 
 
 
Total bilirubin 
 
 
 
 
 
Total protein 
 
 
 
 
 
Triglycerides 
 
 
 
 
 
Urea (blood urea 
nitrogen [BUN]) 
 
 
 
 
 
Creatine Kinase 
(CK) 
 
 
 
 
 
1 Analyzed at a central laboratory. 
2 Analyzed at the study center by use of a dipstick (if allowed per local regulations). 
3 Only analyzed at Visits 3, 10/B1, B6 and B10). 
Investigators at study centers will be notified of safety laboratory test results.  All 
laboratory results will be reviewed and the reports signed by an investigator.  Any 
results considered to be of clinical significance must be addressed and followed up as 
clinically appropriate.  The results of THC screening will be reported back to the 
study site to permit confirmation of eligibility.  Any samples reported to be THC-
positive at screening must be sent for analysis by gas chromatography–mass 
spectrometry at the central laboratory.  


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All laboratory results considered to represent an AE must be documented in the CRF. 
See Section 12.8 for guidance on evaluation of potential drug-induced liver injury.  
Repeat samples will be taken, if required, for clinical follow-up or if the sample is lost 
or damaged.  Any abnormal end of treatment clinical laboratory result of clinical 
significance must be repeated at regular intervals until it returns to normal, or until an 
investigator is satisfied that the abnormality is not related to the IMP and needs no 
further investigation.  
Sample volume requirements and processing procedures will be detailed in a separate 
laboratory manual.  The patient/caregiver must be advised that it may not be safe for 
them to undertake further blood tests within one month of any study-related blood 
draws and to inform the investigator if they suffered any blood loss.  The volume of 
blood drawn at each visit should be tracked.  Where the required blood draw volume 
for study samples exceeds guidance at a particular visit, safety parameters 
(biochemistry and hematology) should be prioritized. 
9.2.9.1 
Pharmacokinetic Blood Sampling 
The plasma concentration/time curves of CBD and its major metabolites will be 
assessed at Visits 3 and 10 for patients weighing more than 20 kg.  Where 
appropriate, blood samples will be taken as follows: 
• One sample pre-dose (i.e., prior to administration of IMP). 
• One sample between 2 and 3 hours post-dose. 
• One sample between 4 and 6 hours post-dose.  
• One sample between 8 and 10 hours post-dose (patients 18 years and above 
only).  
There must be a minimum period of at least two hours between each of the blood 
sampling time points.  In the event of an AE that, in the opinion of the investigator, is 
related to a concomitant AED, additional blood samples may be collected. 
For patients who undergo PK blood sampling, the patient/caregiver will record all 
meal times and the types of meals consumed by the patient during all PK testing days 
(Visits 3 and 10). 
Analysis of all pharmacokinetic samples will be conducted at a central clinical 
laboratory.  Sample volume requirements and processing procedures will also be 
detailed in a separate laboratory manual.  


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The patient/caregiver must be advised that it may not be safe for them to undertake 
further blood tests within one month of any study-related blood draws and to inform 
the investigator if they suffered any blood loss during the one-month period leading 
up to a planned blood draw.  
9.2.9.2 
Determination of Plasma Concentrations of Concomitant 
Antiepileptic Drugs 
Plasma concentrations of concomitant AEDs will be assessed at Visits 3, 5, 7, 9 and 
10/ the Withdrawal visit (if possible) during the blinded phase and at Visits B2, B3, 
B4 and all subsequent Assessment Visits during the OLE.  Samples will be collected 
for all patients provided that the risk/benefit outcome is favorable in the investigator’s 
opinion.  At each visit, blood samples will be taken prior to administration of IMP. 
Patients will be instructed to record the dosing time of their concomitant AEDs in the 
diary. 
Additional blood samples may be taken for AED monitoring if there is a suspicion of 
changes in AED levels, with the aim to keep the AED plasma levels within the 
patient’s therapeutic level.  AED doses should be adjusted, as appropriate, following 
discussion with the GW medical monitor in order to maintain stable AED plasma 
concentrations. 
9.2.9.3 
Determination of Mutation Status of the TSC1 and TSC2 
Genes 
If the mutation status of TSC1 and TSC2 is unknown at screening, genetic analysis 
will be carried out if the patient/parent(s)/legal representative provides consent (a 
blood sample will be taken during Visit 1). 
9.2.10 
Interactive Voice Response System 
The IVRS will be used to collect patient reported diary data (refer to Section 9.2.11), 
to assign patients to treatment groups and to provide treatment allocation information 
in the event of patient unblinding.  The IVRS will also be used to manage IMP 
supply. 
A member of the study team must contact the IVRS at each clinic visit in order to: 
• Allocate a patient number at screening (Visit 1). 
• Randomize a patient (Visit 3). 
• Obtain dispensing information (Visits 3, 4, 5, 6, 7, 9 and during OLE). 


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• Provide completion/taper/premature termination information (Visit 10). 
Training will be given to all centers prior to the start of the study. 
9.2.11 
Patient Diary 
A diary will be completed daily throughout the study.  Patients or their caregivers will 
be instructed on how to complete the diary and will be asked to record information 
daily.  The number and type of seizures and the severity of focal seizures as well as 
information on AEs, concomitant AEDs and rescue medication will be collected each 
day from baseline (Visit 2).  Information on IMP intake will also be recorded each 
day from randomization (Visit 3) until completion of dosing or withdrawal (Visit 
10/Withdrawal visit). 
Seizure information, including the number and seizure subtype, as well as the severity 
of focal seizures and the number of episodes of status epilepticus will be collected 
through an IVRS telephone diary completed daily throughout the blinded phase of the 
study by the patient or their caregiver.  This IVRS telephone diary will be completed 
on a weekly basis during the OLE.  The patient or their caregiver will also complete a 
paper diary daily to record AEs, concomitant AEDs, IMP intake and rescue 
medication throughout the study. 
The following seizure subtypes will be collected daily in the IVRS telephone diary: 
• Focal motor seizures without impairment of consciousness or awareness# 
• Focal seizures with impairment of consciousness or awareness# 
• Focal seizures evolving to bilateral generalized convulsive seizures#  
• Generalized seizures:  
− Tonic–clonic# 
− Tonic# 
− Clonic# 
− Atonic# 
• ‘Other’ seizures: 
− Absence seizures** 
− Myoclonic seizures** 


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− Focal sensory seizures** 
− Infantile/epileptic spasms** 
• Episodes of status epilepticus 
# To be included in primary seizure endpoint. 
** To be included in composite ‘other’ seizure count. 
For the purposes of calculating the composite seizure score, the severity of focal 
seizures will be assessed according to the following criteria: 
• Type 1 - Focal motor seizures without impairment of consciousness or 
awareness. 
• Type 2 - Focal seizures with impairment of consciousness or awareness. 
• Type 3 - Focal seizures evolving to bilateral convulsive seizures. 
9.2.12 
Questionnaires and Assessments Completed at Scheduled 
Visits  
Questionnaires should be completed by the patient or the caregiver, as appropriate.  
The same person should answer/complete the questionnaires/assessments in order to 
maintain consistency.  The C-SSRS/Children’s C-SSRS (where applicable) will be 
administered by a trained rater. 
9.2.12.1 
Subject/Caregiver Global Impression of Change 
The SGIC/CGIC, as appropriate, will be performed for all patients.  At Visit 3 the 
patient or patient’s caregiver will be asked to write a brief description of the patient’s 
overall condition as a memory aid for the SGIC/CGIC at subsequent visits.  It is 
preferred that the same person performs this assessment at each visit. 
The CGIC comprises the following question to be rated on a seven-point scale: 
• Since your child started treatment, please assess the status of your child’s 
overall condition (comparing their condition now to their condition before 
treatment) using the scale below. 
The SGIC comprises the following question to be rated on a seven-point scale: 
• Since you started treatment, please assess the status of your overall condition 
(comparing your condition now to your condition before treatment) using the 
scale below. 


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The markers are: Very Much Improved; Much Improved; Slightly Improved; No 
Change; Slightly Worse; Much Worse; Very Much Worse.  
If the main caregiver is not available at the appropriate visit then this information can 
be captured over the telephone, ideally on the day of the visit or otherwise within 
three days. 
9.2.12.2 
Physician Global Impression of Change 
The PGIC will be performed for all patients.  At Visit 3 the investigator will be asked 
to write a brief description of the patient’s overall condition as a memory aid for the 
PGIC at subsequent visits.  It is preferred that the same investigator performs this 
assessment at each visit. 
The PGIC comprises the following question to be rated on a seven-point scale: 
• Please assess the change in the patient’s general functional abilities since 
Visit 3 (prior to the commencement of study medication). 
The markers are: Very Much Improved; Much Improved; Slightly Improved; No 
Change; Slightly Worse; Much Worse; Very Much Worse.  
If the main caregiver is not available at the appropriate visit then this information can 
be captured over the telephone, ideally on the day of the visit or otherwise within 
three days. 
9.2.12.3 
Subject/Caregiver Global Impression of Change in Seizure 
Duration 
The caregiver will be asked to assess the average duration of the patient’s seizures at 
Visit 3 (i.e., prior to commencement of IMP) as a memory aid for subsequent visits.  
The SGIC-SD/CGIC-SD comprises a question to be rated on a three-point scale for 
each seizure subtype: 
The markers are: Average duration of seizures has decreased; Average duration of 
seizures has stayed the same; Average duration of seizures has increased. 
If the main caregiver is not available at the appropriate visit then this information can 
be captured over the telephone, ideally on the day of the visit or otherwise within 
three days. 
CGIC-SD: 


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• Since the patient started treatment, please assess the average duration of the 
patient’s seizures (comparing their condition now to their condition before 
treatment) using the scale below. 
SGIC-SD: 
• Since you started treatment, please assess the average duration of your 
seizures (comparing their condition now to their condition before treatment) 
using the scale below. 
9.2.12.4 
Quality of Life in Childhood Epilepsy (18 Years of Age and 
Younger) or Quality of Life in Epilepsy (19 Years of Age and 
Older) 
The QOLCE and the QOLIE-31-P are composed of 16 and 31 subscales, respectively, 
assessing seven domains of Health Related Quality of Life (physical function, social 
function, emotional well-being, cognition, behavior, general health and general 
quality of life).  The QOLCE (and QOLIE-31-P, if completed by the caregiver) must 
be completed by a person who interacts with the patient on a consistent, daily basis. 
Quality of life assessments will be performed for all patients.  The questionnaires 
should take 20–30 minutes to complete. 
9.2.12.5 
Vineland Adaptive Behavior Scales, Second Edition 
The Vineland-II is an individually administered instrument for assessing adaptive 
behaviors. Communication, Daily Living Skills, Socialization, and Motor Skills will 
be assessed by the caregiver using a rating scale.  Vineland-II assessments will be 
performed for all patients. 
9.2.12.6 
Child/Adult Behavior Checklist 
Achenbach CBCL and ABCL, for ages 1½–5, 6–18 and 18–59 examine internalizing 
behaviors (such as depression and anxiety), externalizing behaviors (such as 
aggression), stress, obsessive-compulsive behaviors and ‘sluggish cognitive tempo’. 
Statements about the patient’s behavior are recorded on a Likert scale: 0 = Not True, 
1 = Somewhat or Sometimes True, 2 = Very True or Often True. 
The age appropriate checklist will be used for all patients. 
9.2.12.7 
Social Communication Questionnaire 
The current version of the SCQ will be completed by the caregiver for all patients 
above the age of 4 years with a mental age of at least 2 years.  The scale provides 


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sub-scores to assess the domains Reciprocal Social Interaction, Communication and 
Restricted, Repetitive and Stereotyped Patterns of Behavior.  The scale assesses 
behavior over the most recent three month period using 40 questions, each to be 
answered ‘yes’ or ‘no’.  
9.2.12.8 
Suicidality/ Children’s/Columbia-Suicide Severity Rating 
Scale (Six Years of Age and Older) 
Suicidality will be assessed either by using the C-SSRS/Children’s C-SSRS or, in 
patients with profound cognitive impairment, by the investigator’s clinical judgment 
following interview of the patient.  Where the C-SSRS/Children’s C-SSRS is not 
considered appropriate and clinical interview is used instead, the reason must be 
clearly documented by the investigator. 
The definitions of behavioral suicidal events used in this scale are based on those used 
in the Columbia Suicide History Form.  Questions are asked on suicidal behavior, 
suicidal ideation and intensity of ideation.  During the screening visit (Visit 1), 
questions will be in relation to lifetime experiences, and all subsequent questioning 
will be in relation to the last assessment (Since Last Visit). 
The C-SSRS is to be completed by the investigator or his/her qualified delegate at 
every visit as indicated in the Schedule of Assessments (see APPENDIX 1); 
“qualified delegate” is defined as anyone who has completed the C-SSRS training 
within the past two years or has continually administered the C-SSRS assessments 
throughout this trial since obtaining the training certificate.  The survey should be 
completed by the same assessor, where possible, throughout the study.  The 
Children’s C-SSRS will be used for patients aged 6–18 (inclusive) whilst the C-SSRS 
will be used for patients aged 19 and older. 
9.2.12.9 
Wechsler Tests 
The Wechsler Tests are age specific and will only be administered at a sub-group of 
centers that have the expertise to conduct the assessments (ideally before any other 
study procedures but can be completed on a separate day, if necessary, within three 
days of the visit).  Each assessment will need to be conducted by an experienced 
psychometrician.  The age of the patient at entry will be the age used when choosing 
the items to be administered.  Children and adults are to complete the tests as able. 
The following Wechsler Subtests will be used: 
Age 2–6: 


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• WPPSI-4 - Vocabulary and Matrix Reasoning 
Age 6–Adult: 
• WASI-2 - Vocabulary and Matrix Reasoning 
• WISC-4 and WAIS-4 Digit Span and Coding  
9.2.13 
Menstruation 
Caregivers will be asked if the female patient is menstruating and details will be 
recorded as part of their baseline (Visit 3); any changes in normal cycles will be 
captured at Visit 10/Withdrawal visit and subsequent OLE visits. 
9.2.14 
Tanner Staging 
The pubic hair growth (both sexes), genital (males only) and breast (females only) 
development of all adolescent patients (i.e., 10 to 17 years of age at the time of 
signing the informed consent form, or earlier if clinically indicated by onset of 
menarche or other signs of precocious puberty) will be assessed using Tanner 
Staging55 (see APPENDIX 2).  The patients will undergo a discreet physical 
examination and be assigned a value under each category of Pubic Hair Growth (both 
sexes), Genitals (male patients only), and Breasts (female patients only). 
Once a patient reaches a score of V (i.e., 5) the examination need not be performed 
again. 
9.2.15 
Investigational Medicinal Product Accountability 
Records of IMP accountability will be maintained according to Section 5.3.4. 
9.2.16 
Adverse Events 
Any adverse changes in the patient’s medical condition, following completion of the 
consent form by the patient, will be recorded on the CRF as AEs, questioning the 
patient further if necessary.  All AEs* occurring during the study, whether or not 
attributed to the IMP, observed by the investigator or reported by the patient will be 
recorded in the CRF.  
*For the patient’s expected seizure types, these do not routinely require 
documentation as AEs.  However, any worsening, including change in the pattern or 
severity of seizures, must be documented as an AE.  As part of the ongoing safety 
review, the SMC will monitor any worsening of seizures, including change in the 


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pattern or severity.  Any AE which meets SAE criteria should still be reported as a 
SAE. 
SAEs must be reported to GW Pharmacovigilance Department (PVD) within 24 hours 
of discovery or notification of the event, and recorded in the CRF. 
Refer to Section 12 for definitions, procedures and further information. 
The number of inpatient hospitalizations that are, in the investigator’s opinion, due to 
epilepsy will be recorded in the patient’s CRF and through the SAE reporting process. 
9.2.17 
Monitoring of Abuse Liability (for Patients 12 Years of Age and 
Older) 
There are two triggers that will require the investigator or study coordinator to discuss 
abuse potential signals with the patient or their caregiver.  These are either AEs of 
interest that may be reported by the patient/caregiver, or drug accountability issues 
regarding overuse of the IMP or missing bottles.  Different questionnaires will be 
completed by the site depending upon which trigger occurs (see Figure 9.2.17.4-1, 
Section 9.2.17.4).  Irrespective of the above, all patients/caregivers will be 
interviewed at their final dosing visit (‘End of Treatment’/Withdrawal visit or ‘End of 
Taper Period’ visit, as applicable) of the blinded phase and again at their final dosing 
visit of the OLE, and a Study Medication Use and Behavior Survey will be completed 
by the investigator or study coordinator.  Investigators and study coordinators will be 
provided with training on how to complete and perform the processes outlined in this 
section.  This training must be completed and documented by the relevant site staff 
prior to implementation at site. 
9.2.17.1 
Monitoring of Adverse Events 
AE information will be collected according to Section 9.2.16. 
9.2.17.1.1 
List of ‘Triggering Adverse Events of Interest’ 
During the collection of AEs, if the patient reports an AE consistent with any of the 
following categories, then the investigator or study coordinator is required to 
complete an additional Supplemental Adverse Event Form and a Site Classification 
Form (investigator only) following further discussion of the event(s) with the patient 
or their caregiver.  The categories are: 
• Euphoria or inappropriate elation. 
• Inappropriate laughter or exhilaration. 


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• Mood changes. 
• Drunk, high or intoxicated. 
• Hallucinations (visual or auditory), dissociations, disorientation, agitation. 
• Disturbance in cognition, memory, or attention. 
• Drug abuse. 
• Drug withdrawal or drug withdrawal syndrome. 
• Addiction. 
• Overdose. 
• Misuse of IMP. 
• Thoughts of suicide, attempted suicide or suicide. 
An AE that is consistent with the above categories will be known as a ‘triggering AE 
of interest’ for the purposes of this study. 
9.2.17.1.2 
Supplemental Adverse Event Form 
This form consists of 15 questions regarding the AE and use of IMP.  It is completed 
as part of an interview with the patient/caregiver when a triggering AE of interest is 
reported.  It is important that this is completed by a trained investigator or study 
coordinator with the patient/caregiver present.  The answers on the Supplemental 
Adverse Event Form will then be transcribed into the patient’s CRF for the study.  If 
the Supplemental Adverse Event Form cannot be completed at the time the triggering 
AE of interest is reported, then the site should contact the patient/caregiver to obtain 
the required answers as soon as possible. 
9.2.17.1.3 
Monitoring Drug Accountability Discrepancies 
Any time after enrollment until final collection of study data, drug accountability 
discrepancies are monitored as follows:  
• At routine Drug Accountability collection times: 
the site personnel will collect the IMP clinical supplies and make sure the 
usage is in line with the expectations reported within the paper diary. 
• At any time that the site is informed by either the IVRS or by the 
patient/caregiver about any overuse of IMP, suspected misuse, abuse, or 
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9.2.17.1.4 
List of ‘Triggering Drug Accountability Discrepancies’ 
If there are any discrepancies in drug accountability as outlined by the criteria below, 
known as ‘triggering drug accountability discrepancies’, then the trained investigator 
or study coordinator will complete a Supplemental Drug Accountability Form and 
Site Classification Form (investigator only) following further discussion of the 
event(s) with the patient/caregiver.  The triggering drug accountability discrepancies 
are as follows: 
• Missing bottle(s). 
• Compliance issues where one or more bottles are used compared to what was 
the expected use, according to the paper diary. 
• Returned IMP supply with evidence of tampering.  
• Greater than the target daily dose as recorded in the paper diary. 
9.2.17.1.5 
Supplemental Drug Accountability Form 
This form consists of eight questions regarding various aspects of drug accountability 
and patient usage.  It is completed as part of an interview with the patient/caregiver 
when a triggering drug accountability discrepancy is identified.  It is important that 
this is completed by a trained investigator or study coordinator with the 
patient/caregiver present.  The answers on the Supplemental Drug Accountability 
Form will then be transcribed into the patient’s CRF for the study.  The accountability 
reporting procedures will still occur.  If the Supplemental Drug Accountability Form 
cannot be completed at the time the triggering drug accountability discrepancy is 
identified, then the site should contact the patient/caregiver by telephone to obtain the 
required answers as soon as possible. (Note: IMP refers to GWP42003-P, not other 
concomitant medications). 
9.2.17.2 
Site Classification Form 
The investigator should review the applicable Supplemental Adverse Event Form or 
Supplemental Drug Accountability Form, and then complete the Site Classification 
Form.  For each Supplemental Adverse Event Form or Supplemental Drug 
Accountability Form completed, there should be an associated Site Classification 
Form. 
The Site Classification Form requires the investigator to assign the finding to an 
appropriate classification and then to also assign the possible relationship to the IMP.  


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The investigator is also required to indicate the level of the certainty of the 
classification.  The answers from the Site Classification Form will then be transcribed 
into the patient’s CRF for the study. 
9.2.17.3 
Study Medication Use and Behavior Survey 
This form consists of 18 questions regarding the use of the IMP. The trained 
investigator or study coordinator will complete this survey as an interview with the 
patient/caregiver at the final dosing visit (‘End of Treatment’/Withdrawal visit or 
‘End of Taper Period’ visit, as applicable) of the blinded phase and again at the final 
dosing visit of the OLE.  The answers on the Study Medication Use and Behavior 
Survey will then be transcribed into the patient’s CRF for the study.  
The Study Medication Use and Behavior Survey will be completed for all patients 
12 years of age and older in the study and not only those that have reported a 
triggering AE or drug accountability discrepancy. 
9.2.17.4 
Adjudication Committee: Assessment of Abuse Potential of 
GWP42003-P 
A formal Adjudication Committee will be appointed and assigned to this initiative to 
classify triggered cases.  The Adjudication Committee will meet on a periodic basis to 
review and assess all of the information collected on triggered cases.  
A detailed charter will be agreed, which will describe the roles, responsibilities and 
duties of the members of Adjudication Committee.  The Committee will review all of 
the information collected in the process and in the assessment of the abuse potential of 
GWP42003-P, such as:  
• All triggering AE information. 
• Supplemental Adverse Event Form (if applicable). 
• All triggering drug accountability discrepancies. 
• Supplemental Drug Accountability Form (if applicable). 
• Site Classification Form. 
• Study Medication Use and Behavioral Survey. 
• Additional information from site(s) as requested by the Committee. 


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The Adjudication Committee will assess all of the information.  It will form a position 
on the classification of each event and will write a study-related report, detailing the 
conclusions and recommendations. 
The overall process is summarized in Figure 9.2.17.4-1. 
 


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Figure 9.2.17.4-1 
Flow Diagram for Identifying and Evaluating Clinical Trial 
Adverse Event Data Through Systematic Categorization, 
Tabulation and Analysis which can Illuminate an Abuse 
Potential Signal (for Patients 12 Years of Age and Older) 
 
 
Stage 1 
Patients with ‘Triggering 
Adverse Events of Interest’ 
Patients with ‘Triggering Drug 
Accountability Discrepancy’ 
All 
patients  
When a Triggering Adverse Event 
of Interest is identified, a patient 
interview is conducted with the 
Supplemental Adverse Event 
Form and, if applicable, the 
Supplemental Drug 
Accountability Form. 
When a Triggering Drug 
Accountability discrepancy is 
identified, a patient interview is 
conducted with the Supplemental 
Drug Accountability Form and, 
if applicable, the Supplemental 
Adverse Event Form. 
Investigator completes a Site Classification Form after supplemental 
information is collected, drug accountability evaluated, and the patient 
evaluated. One Site Classification Form is completed per Supplemental 
Adverse Event Form or Drug Accountability Form. 
Stage 2 
Stage 3 
Site completes Study Medication Use and Behavior Survey at end of dosing. 
Stage 4 
Adjudication Committee 
Evaluates all of the information collected (as detailed above in stages 1–4) in the 
assessment of the abuse potential of GWP42003-P and completes a report.  
 Committee submits a report to GW. 
Stage 5 


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10 
WITHDRAWAL 
In accordance with the Declaration of Helsinki56, the ICH Tripartite Guideline for 
GCP Topic E6(R2)52, the U.S. FDA regulations relating to good clinical practice and 
clinical trials57,58,59, the European Union (EU) Clinical Trials Directive60, the EU 
Good Clinical Practice (GCP) Directive61 and/or other applicable regulations, a 
patient has the right to withdraw from the study at any time and for any reason 
without prejudice to his or her future medical care by the physician or at the 
institution. 
The patient must be withdrawn from the study if any of the following apply: 
• Administrative decision by the investigator, GW, or a Regulatory Authority. 
• Pregnancy. 
• Protocol deviation that is considered to compromise potentially the safety of 
the patient. 
• Withdrawal of patient consent/assent. 
• Withdrawal of parent(s)/legal representative consent. 
• ALT or AST > 3 × ULN with the appearance of fatigue, nausea, vomiting, 
right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia 
(> 5%). 
• ALT or AST > 8 × ULN. 
• ALT or AST > 5 × ULN for more than two weeks. 
• ALT or AST > 3 × ULN and (TBL > 2 × ULN or INR > 1.5).  
• Lost to follow-up. 
Note: Prior to withdrawal for the transaminase elevations noted above, the 
investigator may choose to confirm the transaminase elevations by repeating 
the following laboratory tests within 24 to 48 hours: ALT, AST, TBL, INR, 
%eosinophils, gamma-glutamyl transferase and alkaline phosphatase.  Should 
the above transaminase elevation criteria be confirmed, the patient must be 
withdrawn from the trial.  In cases where the transaminase elevation 
withdrawal criteria are not met or confirmed, the dose of IMP or a 
concomitant AED with known hepatotoxicity should be reduced following 
discussion with the GW medical monitor. 


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Patients may also be withdrawn from the study for any of the following: 
• Did not meet eligibility criteria. 
• Patient non-compliance. 
• AE (including clinically significant laboratory result) which, in the opinion of 
the investigator, would compromise the continued safe participation of the 
patient in the study. 
• Suicidal ideation or behavior of type 4 or 5 during the treatment period, as 
evaluated with the C-SSRS. 
• Any evidence of drug abuse or diversion. 
• General anesthesia (blinded phase only). 
• Addition of a new AED (blinded phase only). 
Should a patient request or decide to withdraw from the study, all efforts must be 
made to complete all assessments of the End of Treatment/Withdrawal Visit (see 
Section 9.1.1.10 for withdrawals within the double-blind phase and Section 9.1.2.10 
for withdrawals within the OLE phase).  All observations should be reported as 
thoroughly as possible up to the date of withdrawal.  Patients withdrawing due to an 
AE should be followed up according to Section 12.7.  All information should be 
reported in the applicable CRF pages (refer to Section 9.2).  Wherever possible, a 
post-study follow-up visit should take place 28-days after last dose of IMP (refer to 
Section 9.1.1.12 and Section 9.1.2.13).  If withdrawing patients decline to give a 
reason for withdrawal of consent, the investigator must respect the patient’s wishes. 


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11 
URGENT SAFETY MEASURES 
The sponsor and investigator may take appropriate urgent safety measures in order to 
protect the patients of a clinical trial against any immediate hazard to their health or 
safety.  If such measures are taken by the investigator they must notify GW 
immediately or at least within 24 hours of awareness. GW will report urgent safety 
measures to Regulatory Authorities by telephone within 24 hours of awareness, 
wherever possible, and will provide a written report to the Regulatory Authorities and 
EC/IRB within three days. 


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12 
ADVERSE EVENT REPORTING 
12.1 
Definitions 
12.1.1 
Adverse Event 
For the purposes of this study an AE is defined as: 
Any new unfavorable/unintended signs/symptoms (including abnormal laboratory 
findings when relevant), or diagnosis or worsening of a pre-existing condition, which 
occurs following screening (Visit 1) and at any point up to the post-treatment, safety 
follow-up visit (Visit 12 and Visit OLE Follow-up), which may or may not be 
considered to be related to the IMP.  Any event that is the result of a study procedure 
must be recorded as an AE. 
Surgical/Investigational procedures are not AEs.  The medical reason for the 
procedure is the AE.  Elective hospitalizations for pre-study existing conditions or 
elective procedures are not AEs.  The exception may be if the patient has an AE 
during hospitalization which prolongs their scheduled hospital stay in which case it 
would be considered a SAE (refer to Section 12.2). 
If reporting a fatal event, the SAE term should be the underlying cause of the death 
(e.g., disease or medical condition leading to death).  
12.1.2 
Investigator 
The term investigator refers to the study PI or a formally delegated study physician.  
12.2 
Serious Adverse Events 
During clinical investigations, AEs may occur which, if suspected to be IMP-related, 
might be significant enough to lead to important changes in the way the IMP is 
developed (e.g., change in dose, population, monitoring need, consent/assent forms).  
This is particularly true for events that threaten life or function. Such SAEs will be 
reported promptly to Regulatory Authorities, applicable ECs/IRBs and investigators 
(expedited reporting) by GW. 
An AE must only be classed as serious, i.e., a SAE, when the event falls into one of 
the following criteria: 
• Results in death. 
• Is life-threatening*. 


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• Requires inpatient hospitalization or prolongation of existing hospitalization. 
• Results in persistent or significant disability/incapacity. 
• Is a congenital anomaly/birth defect. 
• Is medically significant**. 
* The term “life-threatening” in the definition of “serious” refers to an event in which 
the patient was at risk of death at the time of the event; it does not refer to an event 
which, hypothetically, might have caused death if it were more severe. 
** Medical and scientific judgment should be exercised in deciding whether SAE 
reporting is appropriate in other situations.  Important medical events may not be 
immediately life-threatening or result in death or hospitalization but may jeopardize 
the patient or may require intervention to prevent one of the other outcomes listed in 
the definition above.  These should also usually be considered serious.  Examples of 
such events are intensive treatment in an emergency room or at home for allergic 
bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, or 
development of drug dependency or drug abuse. 
The sponsor considers all convulsive and non-convulsive status epilepticus events 
to be medically significant and should be reported to the Sponsor as medically 
significant SAEs. 
12.3 
Reporting Procedures for Serious Adverse Events 
All SAEs occurring during the study must be reported to GW with any other 
supporting information and recorded in the AE section of the CRF.  Any ongoing 
SAEs should be followed up until resolution wherever possible.  For all deaths, the 
working diagnosis or cause of death as stated on a death certificate, available autopsy 
reports and relevant medical reports should be sent to GW promptly. 
All SAEs must be reported directly to the GW PVD within 24 hours of discovery 
or notification of the event.  All SAE information must be recorded in the SAE 
Report forms provided in the center files and faxed to the GW PVD.  Additional 
information received for a case (follow-up or corrections to the original case) need to 
be detailed on a new SAE Report form, signed/dated and faxed to the GW PVD and 
the AE section of the CRF must be updated. 
The investigator is not obliged to actively monitor for any new SAEs which occurred 
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However, if the investigator becomes aware of any deaths or a new IMP-related SAE 
occurring within 28 days of the final dose of IMP, these should be reported to the GW 
PVD.  
Any other problem discovered outside these time limits (Visit 12 or OLE Follow-up) 
which is deemed to be an unexpected safety issue and is likely to have an impact on 
patients who have taken part in the study must be treated as an SAE and reported to 
the GW PVD.  Such post-study SAEs do not need to be recorded in the patient’s CRF 
if editing rights to the CRF have been removed due to final study data lock.  GW PVD 
may request safety follow-up information after the final study visit in order to 
investigate a potential safety issue. 
Contact details for the GW PVD are provided at the front of the center files for all 
study centers, and upon the GW SAE Report form. 
12.4 
Pregnancy 
Any patient, or patient’s partner, who has become pregnant whilst receiving IMP, or 
within 90 days of last dose of IMP, must be reported to the GW PVD, using the GW 
Pregnancy Monitoring forms provided.  Where possible the investigator should 
provide the outcome of the pregnancy. 
Pregnancy reports must be sent to the GW PVD using the fax number for SAE 
reporting (see Appendix 3.2) within 24 hours of becoming aware. 
The investigator is not obliged to actively monitor for any pregnancies that commence 
more than 90 days after the final dose of IMP.  However, if the investigator becomes 
aware of a new pregnancy outside this time limit then they should report it as above.  
The GW PVD will follow up for all pregnancy outcomes. 
12.5 
Causality Assessment 
Causality assessment is required for all AEs and SAEs.  Causality assessment must 
only be assigned by the investigator.  All cases judged as having a reasonable 
suspected causal relationship to the IMP must be reported as such.  The expression 
“reasonable causal relationship” is meant to convey in general that there are facts 
(evidence) or arguments to suggest a causal relationship. 
The following question which must be answered by the investigator for all AEs is 
used to capture the reasonable causal relationship of an event to the IMP: 
“In your opinion is there a plausible relationship to the IMP?” The answer is either 
“yes” or “no”. 


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Events that start before the first dose of IMP (pre-treatment) should be considered as 
not causally related.  Where a pre-treatment event worsens in severity following the 
first dose of IMP, a new event record should be entered into the CRF. 
Considering the explanation given above, investigators are strongly encouraged to 
express their opinion on what the cause of an AE might be.  For individual patients, 
the investigator is usually in the best position to assess the underlying suspected cause 
of an AE.  For all AEs, and especially SAEs, it is important that the investigator 
assess not only the possible role of the IMP but also other potential contributing 
factors. Factors for consideration of the underlying cause may include: 
• Medical and disease history. 
• Lack of efficacy/worsening of treated condition. 
• Concomitant or previous treatment. 
• Withdrawal of IMP. 
• Protocol-related procedure. 
12.6 
Reporting Procedures for All Adverse Events 
All AEs (including SAEs) occurring during the study will be reported on the running 
logs in the AE section of the CRF.  This includes all events from the time following 
screening (Visit 1) up to and including the post-study follow-up visit (Visit 12 or OLE 
Follow-up), whether or not attributed to IMP and observed by the investigator or 
patient.  
The following information will need to be provided for all AEs: 
A) Adverse Event (Diagnosis or Syndrome if Known, or Signs and Symptoms) 
Where the investigator cannot determine a diagnosis, signs or symptoms should be 
recorded in the AE section of the CRF.  Once a diagnosis has been determined the AE 
section of CRF must be updated to reflect the diagnosis in replacement of the original 
symptoms.  In circumstances where only a provisional diagnosis is possible (working 
diagnosis), the CRF must be updated to reflect the provisional diagnosis in 
replacement of the original symptoms.  In some circumstances it may be relevant for 
the investigator to include the symptoms alongside the diagnosis in the verbatim event 
description.  However, the diagnosis (full or provisional) should be clearly stated 
(e.g., headache and fever due to pneumonia). 


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B) Adverse Event Start Date and Stop Date 
The start and stop dates of the event must be provided.  All AEs require these fields to 
be completed in full.  Partial dates or missing dates are not normally acceptable and 
significant effort must be undertaken to obtain any unknown information.  If a precise 
date is not known an estimated date should be provided instead.  When a complete 
date cannot be given then record as much information as possible (i.e., month and 
year or, in exceptional circumstances, just year).  When the actual start date becomes 
known the CRF must be updated to replace the previously recorded date. 
C) Outcome 
The outcome of the event must be recorded accurately and classified into one for the 
following categories: 
• Recovered. 
• Recovered with sequelae. 
• Continuing. 
• Patient died. 
D) Severity 
When describing the severity of an AE the terms mild, moderate, or severe should be 
used.  Clinical judgment should be used when determining which severity applies to 
any AE. 
If the severity of an AE fluctuates day-to-day, e.g., a headache or constipation, the 
change in severity should not be recorded each time; instead, only the worst observed 
severity should be recorded with AE start and stop dates relating to the overall event 
duration, regardless of severity.  
A severe AE is not the same as a SAE.  For example, a patient may have severe 
vomiting but the event does not result in any of the SAE criteria above.  Therefore, it 
should not be classed as serious. 
E) Causality 
See Section 12.5 above. 
F) Action Taken with Study Medication 
This question refers to the action taken with the IMP due to an AE.  The action with 
the IMP must be classed as: 


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• None. 
• Dose reduced temporarily. 
• Dose reduced. 
• Study medication interrupted. 
• Study medication stopped. 
12.7 
Follow-up Procedures for Adverse Events 
The investigator may be asked to provide follow-up information to the GW PVD for 
any AEs reported or during the investigation of potential safety issues.  Such requests 
for additional safety information may occur post Visit 11 or OLE Follow-up after the 
study. 
AEs considered related to the IMP by the investigator or the sponsor should be 
followed up until resolution or the event is considered stable.  
It will be left to the investigator’s clinical judgment whether or not an AE is of 
sufficient severity to require the patient’s removal from treatment.  A patient may also 
voluntarily withdraw from treatment due to what he or she perceives as an intolerable 
AE.  Further details of withdrawal are presented in Section 10.  If either of these 
occurs, the patient must undergo an end of treatment assessment and be given 
appropriate care under medical supervision until symptoms cease or the condition 
becomes stable.  If a safety concern is identified following withdrawal of a 
participant, GW may contact the investigator for additional follow-up information. 
12.8 
Potential Cases of Drug-induced Liver Injury  
All investigational centers are required to submit to the GW PVD the laboratory 
results for any patient after randomization that meet the criteria for the selected 
laboratory parameters as follows:  
• ALT or AST > 3 × ULN with the appearance of fatigue, nausea, vomiting, 
right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia 
(> 5%). 
• ALT or AST > 8 × ULN. 
• ALT or AST > 5 × ULN for more than two weeks. 
• ALT or AST > 3 × ULN and (TBL > 2 × ULN or INR > 1.5).  


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These reports must be sent to the GW PVD using the same fax number for SAE 
reporting within 24 hours of becoming aware of the results.  In addition, please send a 
copy of the patient’s baseline laboratory results with all reports to the GW PVD. 
Abnormal values in AST and/or ALT concurrent with abnormal elevations in TBL 
that meet the criteria outlined above are considered potential cases of drug-induced 
liver injury and will be considered as protocol defined criteria for withdrawal and 
important medical events.  The investigator will arrange for the patient to return to the 
investigational site as soon as possible (within 24–48 hours of notice of abnormal 
results) for repeat assessment of ALT, AST, TBL, alkaline phosphatase and 
gamma-glutamyl transferase, detailed history and physical examination.  Patients 
should be followed in this way until all abnormalities have normalized (in the 
investigator’s opinion) or returned to the baseline state; however, if the above 
transaminase elevation criteria are confirmed by the first set of follow-up laboratory 
tests, the patient must be withdrawn from the trial. 
Elevations in ALT or AST > 3 × ULN or TBL > 2 × ULN alone are not considered 
potential cases of drug-induced liver injury, but will be followed as detailed above, 
within 72 hours’ notice of abnormal results.  If the participant cannot return to the 
investigational center, repeat assessments may be done at a local laboratory and the 
results sent to GW PVD. 
12.9 
Notification of Safety Information to Investigators, Regulatory 
Authorities and Ethics Committees. 
In accordance with the EU Clinical Trials Directive60, relevant parts of the FDA Code 
of Federal Regulations62 and any national regulations, GW will inform investigators, 
Regulatory Authorities and relevant ECs/IRBs of all relevant safety information.  This 
will include the reporting of relevant SAEs and all Suspected Unexpected Serious 
Adverse Drug Reactions (SUSARs).  
This information will be provided through three sources: 
1) IB: a compilation of the clinical and non-clinical safety data available on the 
IMP that is relevant to the study.  The IB is updated annually. 
2) Development Core Safety Information: this document forms the safety section 
of the IB51, or is updated as an addendum to the IB51.  This document is 
revised if necessary, when new important safety information becomes 
available (potentially up to a few times a year). 


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3) Council for International Organizations of Medical Sciences (CIOMS) reports: 
these reports are issued every time a SUSAR is reported to GW.  They provide 
information on individual case reports and are sent to all the Regulatory 
Authorities, the relevant central ECs/IRBs which have approved the study and 
investigators.  As required, the investigator should notify their regional 
ECs/IRBs of SAEs or SUSARs occurring at their center and other AE reports, 
i.e., CIOMS reports and any additional safety documentation received from 
GW, in accordance with local procedures. 
In the USA, investigators are normally required to promptly report to their IRBs all 
unanticipated problems involving risks to human patients, or others, including AEs 
that should be considered unanticipated problems.  Based on current FDA guidance57 
the following clarification is provided in determining what constitutes an 
unanticipated problem: 
In general, an AE observed during the conduct of a study should be considered an 
unanticipated problem involving risk to patients and reported to the IRB, only if it 
were unexpected, serious, and would have implications for the conduct of the study 
(e.g., requiring a significant, and usually safety-related, change in the protocol such as 
revising inclusion/exclusion criteria or including a new monitoring requirement, 
informed consent/assent, or IB).  An individual AE occurrence ordinarily does not 
meet these criteria because, as an isolated event, its implications for the study cannot 
be understood. 
In The Netherlands, all SAEs observed during the conduct of a study will be reported 
within the stipulated timelines to the De Medisch Ethische 
Toetsingscommissie/Centrale Commissie Mensgebonden Onderzoek only if it were 
considered an unanticipated problem involving risk to patients and would have 
implications for the conduct of the study (e.g., requiring a significant, and usually 
safety-related, change in the protocol such as revising inclusion/exclusion criteria or 
including a new monitoring requirement, informed consent/assent, or IB).  All other 
SAEs will be reported in a cumulative summary as part of the Development Safety 
Update Report and updated on a yearly basis.  This does not replace the ongoing 
obligation to report any SUSARs originating in The Netherlands, which do not meet 
the above criteria, to the accredited Medical Research Ethics Committee and 
competent authority. 
The FDA guidance62 states that, accordingly, to satisfy the investigator’s obligation to 
notify the IRB of unanticipated problems, any investigators participating in a 


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multicenter study may rely on the sponsor’s assessment and provide to the IRB a 
report of the unanticipated problem prepared by the sponsor. 
GW will inform investigators, Regulatory Authorities and relevant ECs/IRBs of any 
safety issues or case reports that are considered to be unanticipated and provide such 
reports as mentioned above. It should be noted that a single SUSAR report notified to 
investigators in the study does not necessarily constitute an unanticipated problem 
unless identified by GW in the submission cover letter. 
As a minimum, the recipient will be sent all of the above and relevant updates 
between the period from ethical approval and final database lock.  


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13 
STATISTICAL CONSIDERATIONS 
A statistical analysis plan (SAP) will be produced prior to unblinding of the study.  
Any deviations from the original SAP will be described in the final clinical study 
report. 
13.1 
Sample Size, Power and Significance Levels 
Blinded Phase: 
A total of 210 patients will be enrolled.  The 210 patients will be randomly allocated 
to one of four treatment groups (GWP42003-P 25 mg/kg/day, GWP42003-P 
50 mg/kg/day, placebo 25 mg/kg/day dose volume equivalent, or placebo 
50 mg/kg/day dose volume equivalent) at a 2:2:1:1 ratio.  The placebo groups will be 
pooled for the analyses of efficacy. 
If it is assumed that patients in the placebo group will experience a mean reduction in 
seizure frequency of 15% (from baseline), patients receiving GWP42003-P will 
experience at least a 50% reduction in seizures and a common standard deviation of 
60%, then this sample size of 70 patients per group will be sufficient to detect a 
difference in response distributions with 90% power.  This test is based on a two-
sided non-parametric Wilcoxon-Mann-Whitney test for continuous response data with 
a 5% significance level. 
Open-label Extension: 
All patients who wish to continue on IMP following the blinded phase. 
13.2 
Interim Analysis 
Blinded Phase: 
No interim analysis is planned for this study.  The blinded phase of this study will be 
locked and unblinded prior to completion of the OLE.  The SAP covering the blinded 
phase will be finalized prior to unblinding the blinded phase. 
Open-label Extension: 
A cut of the OLE data will be used to support New Drug Application and Marketing 
Authorization Application filings.  Further data cuts may be conducted as required. 


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13.3 
Analysis Sets 
Blinded Phase: 
There will be up to three analysis sets in the blinded phase: 
Intention to Treat (ITT) 
• All patients who are randomized, receive IMP in the study and have 
post-baseline efficacy data will be included and analyzed according to their 
randomized treatment group. 
• The ITT analysis set is the primary analysis set for all efficacy endpoints. 
Per Protocol (PP) 
If there are a sufficient number of significant protocol deviations in the study, a PP 
analysis set may also be presented. 
• All patients who complete the study with no protocol deviations deemed to 
compromise the assessment of efficacy will be included and analyzed 
according to the treatment group they were randomized.  The rules 
determining the PP analysis set will be fully defined prior to unblinding of the 
database. 
Safety 
All patients who received at least one dose of IMP in the study will be included and 
analyzed according to the treatment received.  Only patients for whom it has been 
confirmed that they did not take any IMP will be excluded from this safety analysis 
set. 
Open-label Extension: 
There will be one analysis set in the open-label extension phase: 
Safety 
All patients who received at least one dose of IMP in the open-label extension phase 
of the study will be included.  Only patients for whom it has been confirmed that they 
did not take any IMP in the OLE phase will be excluded from this safety analysis set. 
13.3.1 
Protocol Deviations 
Protocol deviations will be listed and reasons for exclusion from the analysis 
populations will be summarized. 


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13.4 
General Considerations 
Unless stated otherwise, continuous variables will be summarized showing the 
number of non-missing values (n), mean, standard deviation, median, minimum and 
maximum and categorical variables will be summarized showing the number and 
percentage of patients falling in each category. 
Unless otherwise specified, tables for the blinded phases will be summarized by 
randomized treatment group, and for the OLE phase will be summarized overall. 
13.5 
Accountability and Background Characteristics 
13.5.1 
Enrollment and Disposition 
All patients (screened, enrolled/randomized, prematurely terminated IMP) will be 
accounted for in the enrollment and disposition summary tables. 
13.5.2 
Baseline and Demographic Characteristics 
Age, sex, ethnic origin (as allowed per local regulations) and any other demographic 
or baseline characteristics, including history of epilepsy and epilepsy-specific genetic 
testing, will be summarized, using appropriate summary statistics. 
13.5.3 
Medical History 
Previous and current medical conditions will be summarized by System Organ Class 
(SOC), including details of epilepsy. 
13.5.4 
Concomitant Medication 
Concomitant medications (including standard AED and rescue medication) taken 
prior to and during the study will be summarized separately, by medication class and 
active ingredients. 
13.6 
Endpoints and Statistical Methods 
Blinded Phase: 
Statistical hypothesis testing will be performed on the primary endpoint and other 
endpoints as appropriate.  Each endpoint, including the primary will have 
2 comparisons against placebo (25 mg/kg/day GWP42003-P and 50 mg/kg/day 
GWP42003-P vs. placebo).  Also, 3 key secondary endpoints have been defined. 


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The primary and key secondary endpoints will be tested with their Type I error 
controlled by use of a hierarchical gate-keeping procedure, in the sequence given in 
Table 13.6-1.  One must reject the null hypothesis of an endpoint at the level of 0.05 
(2-sided) to test the hypothesis of the subsequent endpoint in the sequence at the level 
of 0.05 (2-sided). If a null hypothesis is not rejected then testing will stop and all 
subsequent analyses will be declared not statistically significant. 
 
13.6.1 
Evaluable Period 
Blinded Phase: 
The start of the evaluable period of the study (Day 1) is defined as the first day the 
patient took IMP, as recorded on the CRF, or the day of randomization if this date is 
unknown. 
The end of the evaluable period is defined as the earliest of: 
• Day 113 of treatment for the IVRS reported efficacy data and the day of 
Visit 10 for the CRF-based efficacy data; 
• The last day on which study IMP was taken (as stated on the study outcome 
CRF) for the IVRS reported efficacy data and the day after this for the 
CRF-based efficacy data; 
• The day before a relevant change in prohibited or AED medications was 
made. 
Open-label Extension: 
All data collected during this phase will be summarized across time, using appropriate 
descriptive statistical methods.  Changes from pre-randomization baseline will also be 
presented.  Treatment compliance and exposure to treatment will also be summarized. 
Table 13.6-1 
Hierarchy for Analysis 
Test 
Endpoint 
Treatment Comparison 
1 
Change from baseline in number of TSC-
associated seizures 
25 mg/kg/day GWP42003-P vs. Placebo 
2 
50% responder analysis 
25 mg/kg/day GWP42003-P vs. Placebo 
3 
Change from baseline in number of TSC-
associated seizures 
50 mg/kg/day GWP42003-P vs. Placebo 
4 
50% responder analysis 
50 mg/kg/day GWP42003-P vs. Placebo 
5 
Change in CGIC/SGIC 
25 mg/kg/day GWP42003-P vs. Placebo 
6 
Change from baseline in total seizures 
25 mg/kg/day GWP42003-P vs. Placebo 
7 
Change in CGIC/SGIC 
50 mg/kg/day GWP42003-P vs. Placebo 
8 
Change from baseline in total seizures 
50 mg/kg/day GWP42003-P vs. Placebo 


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13.6.2 
Primary Endpoint(s) 
Blinded Phase: 
The primary endpoint is the change in number of seizures* during the treatment 
period (maintenance and titration) compared to baseline in patients taking 
GWP42003-P compared with placebo. 
*Seizures include: focal motor seizures without impairment of consciousness or 
awareness; focal seizures with impairment of consciousness or awareness; focal 
seizures evolving to bilateral generalized convulsive seizures and generalized seizures 
(tonic–clonic, tonic, clonic or atonic) that are countable. 
Data will be analyzed using negative binomial regression on the sum of the seizure 
counts during the treatment period.  However, seizure frequency (average per 28 
days) and percentage change in seizure frequency will be presented using summary 
statistics.  A mixed effect model with repeated measures will be performed modelling 
the observed number of seizures in the baseline period and treatment period 
implemented within the framework of general linear models using the negative 
binomial response distribution.  The model will include stratified age group (1–6 
years, 7–11 years, 12–17 years and 18–65 years), time, treatment arm and treatment 
arm by time interaction as fixed effects and patient as a random effect.  The log 
transformed number of days in which seizures were reported will be included as an 
offset.  The time variable corresponds to an indicator for the baseline period and 
treatment period.  The estimated ratio of least squares means for treatment period to 
baseline period and 95% confidence intervals (CIs) will be presented for each 
treatment arm.  In addition, the estimated ratio of each GWP42003-P group to placebo 
and 95% CIs will be presented along with the p-value testing the null hypothesis that 
this ratio is 1. 
The hypothesis testing approach for controlling the Type I error is described in 
Section 13.6 and Table 13.6-1. 
If a patient withdraws from the study, then the primary analysis variable will be 
calculated from the available data, during the treatment period, prior to the patient 
withdrawing. 
Open-label Extension: 
The primary endpoint is the safety of GWP42003-P, evaluated by assessing the 
incidence, type and severity of AEs.  Data will be presented as per Section 13.6.5.2. 


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13.6.2.1 
Sensitivity Analysis for the Primary Endpoint 
Blinded Phase: 
The following sensitivity analyses will be conducted for the primary endpoint for the 
blinded phase: 
• Wilcoxon rank-sum test on percentage change from baseline in seizure 
frequency during the treatment period.  An estimate of the median differences 
between each GWP42003-P group and placebo, together with approximate 
95% CIs, will be calculated using the Hodges–Lehmann approach. 
• Primary endpoint analysis repeated using the PP analysis set. 
• Primary endpoint analysis repeated using the maintenance period (Day 29 to 
the end of the evaluable period) rather than the treatment period. 
• Primary endpoint analysis repeated using the worst case of last observation 
carried forward (LOCF), next observation carried backward (NOCB) and the 
mean from the non-missing data for each patient to impute missing data 
arising from unreported days in IVRS. 
− Any intermittent missing data for the number of seizures arising from 
unreported days in IVRS will be imputed using the worst (highest number 
of seizures) of the following for each patient: LOCF, NOCB and the mean 
daily number of seizures during the treatment period based on non-missing 
data: 
Number of seizures ÷ Number of reported days in IVRS. 
• A rank ANCOVA on percentage change from baseline in number of seizures 
(average per 28 days) during the treatment period. 
− The ranks of the percentage change from baseline and the baseline number 
of seizures (average per 28 days) will be calculated.  The rank of the 
percentage change from baseline will then be analyzed using an ANCOVA 
model with the rank of the baseline number of seizures (average per 
28 days) and age group (1–6 years, 7–11 years, 12–17 years and 18–65 
years) as covariates and treatment group as a fixed factor.  The estimated 
least squares means, treatment differences, together with the 95% CIs and 
p-value will be presented. 
• ANCOVA of log transformed number of seizures (average per 28 days) during 
the treatment period. 


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− The number of seizures (average per 28 days) during the treatment period 
and the baseline number of seizures (average per 28 days) will be log 
transformed prior to analysis.  The log transformed number of seizures 
(average per 28 days) during the treatment period will then be analyzed 
using an ANCOVA model with the log transformed baseline number of 
seizures (average per 28 days) and age group as covariates and treatment 
group as a fixed factor.  The back transformed estimated treatment ratios, 
together with the 95% CIs and p-value will be presented. 
− If there are any patients with no seizures post-baseline, then 1 will be 
added to the number of seizures (average per 28 days) for all patients prior 
to log transformation. 
• Primary endpoint analysis repeated using each 4 weeks of the maintenance 
period (Week 1 to 4, Week 5 to 8 and Week 9 to 12 of the 12-week 
maintenance period) rather than the treatment period. 
− This analysis will include only patients who have at least 7 days of seizure 
data within each corresponding 4-week period. 
• Wilcoxon rank-sum test on percentage change from baseline in number of 
seizures (average per 28 days) during the treatment period, using multiple 
imputation (MI) to impute data under the Missing Not at Random (MNAR) 
assumption. 
− MNAR will be assumed for missing values resulting from two scenarios, 
discontinuation due to AEs, and discontinuation due to any reason in the 
GWP42003-P dose groups and missing at random (MAR) for others, 
including other patients discontinued in the GWP42003-P dose groups and 
patients in the placebo group. 
− MI will be performed on the seizure frequency, based on time points 
corresponding to each 14 calendar days of the treatment period. 
Intermittent missing values for intermediate 14-day time points before the 
last 14-day time-point will be imputed using the MCMC method in SAS 
PROC MI with an IMPUTE=MONOTONE statement for 100 times for 
each treatment group separately.  Then, monotone missing data assumed 
under the MAR assumption at time-point t (i.e., patients in the placebo 
group and patients in the GWP42003-P groups who did not discontinue 
due to AEs or for any reason) will be imputed using the MI procedure with 
the ‘MONOTONE REG’ option, for each treatment group separately.  The 


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imputation model will include baseline seizure frequency and each 14-day 
time-point up to time-point t (in chronological order).  With the data 
imputed from above, monotone missing data of patients in the 
GWP42003-P groups under the MNAR assumption will be imputed. At 
each 14-day time-point t, the input dataset for the MI procedure will 
include all placebo patients and those patients from the GWP42003-P 
groups that have values missing under MNAR at that time-point. The 
imputation model will include seizure frequency at baseline and each 
14-day time-point up to time-point t (in chronological order) and will be 
performed for each GWP42003-P group separately. 
Full details for this sensitivity analysis will be provided in the SAP. 
13.6.3 
Secondary Endpoint(s) 
The following endpoints will be compared between treatment groups over the 
treatment period, for the blinded phase, and during the open-label extension phase 
relative to the pre-randomization baseline of the blinded phase: 
Antiepileptic Efficacy Measures: 
Key: 
• Number of patients considered treatment responders defined as those with a 
≥ 50% reduction in seizure frequency (blinded phase only). 
• Change in CGIC or SGIC score. 
• Change in total seizures. 
The hypothesis testing approach for controlling the Type I error for these endpoints 
are described in Section 13.6 and Table 13.6-1. 
Other: 
• Percentage change from baseline in number of seizures (average per 28 days; 
OLE phase only). 
• Number of patients considered treatment responders defined as those with a 
≥ 25%, ≥ 50% (OLE phase only), ≥ 75% or 100% reduction in seizure 
frequency. 
• Number of patients experiencing a > 25% worsening, − 25 to + 25% no 
change, 25–50% improvement, 50–75% improvement or > 75% improvement 
in seizure frequency. 


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• Change in number of seizure-free days. 
• Change in number of ‘other’ seizures (absence, myoclonic, focal sensory and 
infantile/epileptic spasms). 
Growth and Development (patients less than 18 years): 
• Change in serum IGF-1 levels. 
• Change in Tanner Staging score (for patients aged 10–17 [inclusive]). 
Quality of Life: 
• Changes in the QOLCE (patients 2–18 years) or QOLIE-31-P (patients 
19+ years) score. 
• Change in PGIC score. 
Blinded Phase: 
The number of patient responders (including the key secondary endpoint) and the 
number of patients seizure-free will be summarized and analyzed using a  
Cochran–Mantel–Haenszel test stratified by age group.  In addition, the difference in 
proportions and the odds ratio, together with 95% CIs, comparing the treatment 
groups will be presented. 
For number of seizure-free days, use of rescue medication, number of episodes of 
status epilepticus (only if there is a sufficient number of patients with data), 
Vineland-II, Wechsler scales, CBCL, ABCL, SCQ, QOLCE and QOLIE-31-P scores, 
the data will be summarized at baseline and over the treatment period, and at each 
time-point (or 28-day period, as appropriate) during the maintenance period.  Changes 
from baseline to the average over the treatment period (or at end of study) will be 
analyzed using ANCOVA (or appropriate non-parametric methods if data are found to 
be not normally distributed).  The models will include baseline and age group as 
covariates and treatment group as fixed factor.  The treatment difference, together 
with the 95% CIs will be presented. 
The changes in composite focal seizure score, change in total seizures, the number of 
seizures by subtype and the number of ‘other’ seizures will be analyzed using the 
same analysis as the primary endpoint. 
SGIC-SD/CGIC-SD, SGIC/CGIC and PGIC assessments recorded at the end of 
treatment will be analyzed with ordinal logistic regression using the proportional odds 
model. 


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Changes from baseline for IGF-1 levels will be summarized by treatment group and 
plotted against the Tanner Stages, weight, and height. 
Tanner Stages will be evaluated and summarized descriptively at each time-point in 
terms of frequency and proportions.  Number (%) of patients with changes in Tanner 
Stages will be summarized by treatment group. 
In order to explore the robustness of the primary analysis, further sensitivity analysis 
(in addition to that already detailed in Section 13.6.2.1) may be specified in the SAP. 
Open-label Extension: 
Secondary endpoints will be summarized across time, using appropriate statistical 
methods.  Descriptive statistical methods will be used throughout.  There will be no 
formal hypothesis testing. 
Exploratory Endpoints: 
Antiepileptic Efficacy Measures: 
• Change in composite focal seizure score (frequency × severity). 
• Change in number of seizures by subtype. 
• Change in use of rescue medication. 
• Change in the number of episodes of status epilepticus (convulsive and 
non-convulsive). 
• Changes in duration of seizure subtypes as assessed by the Subject Global 
Impression of Change in Seizure Duration (SGIC-SD) or the Caregiver Global 
Impression of Change in Seizure Duration (CGIC-SD). 
TAND: 
Cognitive and Behavioral Function: 
• Changes in Vineland Adaptive Behavior Scales, Second Edition (Vineland-II). 
• Changes in Wechsler Scales (pre-school, primary, children, adult). 
• Changes in Achenbach Child Behavior Checklist (CBCL) and Adult Behavior 
Checklist (ABCL). 
Autistic Features: 
• Change in Social Communication Questionnaire (SCQ) score. 


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PK (Blinded Phase Only): 
• The plasma concentrations will be summarized by time window for CBD and 
its major metabolites following single and multiple doses of GWP42003-P. 
Where data allows, the area under the plasma concentration curve (AUC0-t) 
from time zero to the last measurable time-point will be calculated. 
• Plasma concentrations of concomitant AEDs before and after treatment with 
GWP42003-P, where available. 
13.6.4 
Pharmacokinetics 
Plasma concentrations for CBD and its major metabolites, following single and 
multiple doses of GWP42003-P will be summarized by treatment group.  Estimates of 
PK parameters will also be summarized using the appropriate statistics. 
Where available, plasma concentrations of concomitant AEDs will be summarized. 
13.6.5 
Safety 
In the presentation of safety data for the blinded phase, data from the two cohorts of 
placebo patients (25 mg/kg/day and 50 mg/kg/day dosing volumes) will be presented 
separately and pooled together.  This will allow the possibility to explore any effects 
of the volume of IMP on safety endpoints. 
13.6.5.1 
Treatment Compliance and Extent of Treatment Exposure 
Treatment compliance and exposure to treatment will be summarized. 
13.6.5.2 
Adverse Events 
AEs will be coded according to the Medical Dictionary for Regulatory Activities 
dictionary. 
A treatment emergent AE is one that started, or worsened in severity or seriousness, 
following the first dose of IMP.  
Descriptive presentations of treatment emergent AEs will be given by preferred term 
and SOC for the safety analysis.  The number of patients reporting at least one AE 
will be provided. 
The following summaries will be produced: 
• All-causality AEs. 


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• Treatment related AEs. 
• All-causality AEs by severity. 
• All-causality serious AEs. 
• Treatment related serious AEs. 
• AEs reported as leading to permanent cessation of study treatment. 
• Fatal AEs. 
13.6.5.3 
Clinical Laboratory Data 
Clinical laboratory data at screening, during and at the end of treatment and the 
change from baseline to end of treatment will be summarized for the safety analysis 
set using appropriate summary statistics.  Categorical shift tables will also be 
presented, showing the numbers of patients with values outside the normal range.  
Baseline for the open-label extension will be pre-randomization baseline. 
13.6.5.4 
Vital Signs, 12-Lead Electrocardiogram, Physical 
Examination and Other Safety Data 
Vital signs, ECG, physical examination, number of inpatient hospitalizations and 
C-SSRS data will be summarized for the safety analysis set, at screening, baseline and 
at each time point during the treatment period using appropriate summary statistics. 
Changes in the vital signs and number of inpatient hospitalizations from baseline to 
end of treatment will also be summarized.  Details of menstruation cycles (in females) 
will be summarized and listed as appropriate. 


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14 
SAFETY MONITORING COMMITTEE 
An independent Safety Monitoring Committee (SMC) will be used in this study. 
Details of the composition and standard operating procedures of the SMC will be 
detailed in a separate charter.  
Furthermore, an independent ESC will be instated to verify the seizure types of 
screened patients on an ongoing basis.  Investigators will submit a documented 
history of TSC directly to the ESC for verification of seizure types.  The ESC will 
provide written documentation directly to the investigator and guidance on seizure 
types, if applicable, for inclusion in the patient file.  Details of the composition and 
standard operating procedures of the ESC will be detailed in a separate charter.  


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15 
REGULATORY AND ETHICAL OBLIGATIONS 
15.1 
Declaration of Helsinki 
The investigator will ensure that this study is conducted in full conformity with the 
current version and subsequent amendments of the Declaration of Helsinki56, the ICH 
Tripartite Guideline for GCP Topic E6(R2)52, the EU Clinical Trials Directive60, the 
EU GCP Directive61 and the clinical trial regulations adopting European Commission 
Directives into national legislation63,64,65,66,67. 
15.2 
Informed Consent/Assent 
An initial generic ICF consent and assent form will be prepared by GW and provided 
to the investigator, who will tailor these for their center by adding the center’s contact 
details and by using headed paper.  The GW Clinical Manager will communicate 
updates to the template by letter.  The written informed consent/assent documents 
should be prepared in the language(s) of the potential patient population. 
Before a patient’s involvement in the trial, the investigator is responsible for obtaining 
written informed consent/assent (if allowed per local regulations) from the patient 
and/or along with written parent(s)/legal representative consent after adequate 
explanation of the aims, methods, anticipated benefits and potential hazards of the 
study and before any protocol specific screening procedures or any IMPs are 
administered.  The patient and/or parent(s)/legal representative should have ample 
time for review to consider the information provided before giving written 
consent/assent, more specific definitions of ample time may be in force if required by 
ECs/IRBs or local regulations. 
The acquisition of informed consent/assent should be documented in the patient’s 
medical records and the ICF should be signed and personally dated by the patient 
and/or parent(s)/legal representative (as applicable) and by the person who conducted 
the informed consent/assent discussion.  GW also requires a physician to be present 
for consent/assent and to sign the consent/assent forms.  The original signed ICF 
should be retained and a copy provided to the patient and/or parent(s)/legal 
representative. 
15.3 
Ethics Committee/Institutional Review Board 
A copy of the protocol, proposed ICF, other patient information material, any 
proposed advertising material and any further documentation requested must be 


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submitted to the EC/IRB for written approval.  GW must receive a copy of the written 
approval of the protocol and ICF before recruitment of patients into the study and 
shipment of IMP. 
The investigator must submit and, where necessary, obtain approval from the EC/IRB 
for all subsequent protocol amendments and changes to the informed consent/assent 
documents.  The investigator should notify the EC/IRB of deviations from the 
protocol, SAEs occurring at the center and other AE reports received from GW, in 
accordance with local procedures. 
The investigator will be responsible for obtaining ongoing EC/IRB approval/renewal 
throughout the duration of the study.  Copies of the investigator’s reports and the 
EC/IRB continuance of approval must be sent to GW. 
15.4 
Pre-study Documentation Requirements 
The investigator is responsible for forwarding the following documents to GW for 
review before allowing any patients to consent/assent for entry into the study: 
• Signed and dated protocol signature page. 
• Copy of EC/IRB-approved ICF and other patient information material. 
• Copy of the EC/IRB approval of the protocol, ICF and other patient 
information material. 
• Up to date curricula vitae and medical licenses (as per local regulations) of the 
PI and all sub-investigators. 
• The EC/IRB composition and/or written statement of the EC/IRB in 
compliance with the FDA regulations relating to GCP and clinical 
trials57,58,59,68, the EU Clinical Trials Directive60, the EU GCP Directive61, or 
the ICH Tripartite Guidelines for GCP Topic E6(R2)52 where the EU Clinical 
Trials and GCP Directives do not apply. 
• Signed laboratory normal ranges and documentation of laboratory certification 
(or equivalent) unless using central laboratory arranged by GW. 
• Signed clinical trial agreement (including patient/investigator indemnity 
insurance and financial agreement). 
• Form FDA 1572, if required. 
• Drug Enforcement Administration license (where applicable). 


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• Completed financial disclosure statements for the PI and all sub-investigators, 
if relevant. 
15.5 
Patient Confidentiality 
The investigator must ensure that the patient’s anonymity is maintained.  In the CRFs 
and within the IVRS databases used to collect the trial data or other documents 
submitted to GW, patients should be identified by their initials and ethnic origin (if 
allowed per local regulations) and their study screening number only.  Documents that 
are not for submission to GW, e.g., signed ICFs, should be kept in strict confidence by 
the investigator. 
In compliance with the FDA regulations relating to good clinical practice and clinical 
trials57,58,59,68, and the EU Clinical Trials Directive60/ICH Tripartite Guidelines for 
GCP Topic E6(R2)52, it is required that the investigator and institution permit 
authorized representatives of the company, the Regulatory Authorities and the 
EC/IRB have direct access to review the patient’s original medical records for 
verification of study-related procedures and data.  Direct access includes examining, 
analyzing, verifying and reproducing any records and reports that are important to the 
evaluation of the study.  The investigator is obligated to inform the patient that his/her 
study-related records will be reviewed by the above-named representatives without 
violating the confidentiality of the patient. 
All information concerning the IMP and operations of GW such as patent 
applications, formulae, manufacturing processes, basic scientific data or formulation 
information supplied to the investigator by the company and not previously published 
is considered confidential by the company and shall remain the sole property of the 
company.  The investigator will agree to use this information only in accomplishing 
the study and will not use it for any other purposes without the written consent of the 
company. 


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16 
ADMINISTRATIVE AND LEGAL OBLIGATIONS 
16.1 
Protocol Amendments and End of Study or Termination 
Protocol amendments must be made only with the prior approval of GW.  Agreement 
from the investigator must be obtained for all protocol amendments and amendments 
to the informed consent/assent documents.  The EC/IRB and Regulatory Authorities 
must be informed of all amendments and give approval for any substantial 
amendments.  Amendments for administrational changes can be submitted to the 
EC/IRB for information only.  The investigator must send a copy of the approval 
letter from the EC/IRB to GW. 
Both GW and the investigator reserve the right to terminate the study, according to 
the clinical trial agreement.  The investigator should notify the EC/IRB in writing of 
the study’s completion or early termination and send a copy of the notification to GW. 
16.2 
Study Documentation and Storage 
The investigator should maintain a list of appropriately qualified persons to whom 
he/she has delegated study duties.   All persons authorized to make entries and/or 
corrections in CRFs will be included on the GW Delegation of Authority and 
Signature form. 
Source documents are original documents, data and records from which the patient’s 
CRF data are obtained.  These include, but are not limited to, hospital records, clinical 
and office charts, laboratory and pharmacy records, diaries, electronic data captured 
by IVRS, microfiches, radiographs and correspondence. CRF entries may be 
considered source data if the CRF is the site of the original recording; that is, there is 
no other written or electronic record of data.  A source data verification plan, 
identifying the source for each data point at each center, will be agreed with each 
center prior to patient recruitment.  In the rare situations of data being recorded 
directly into the CRF in error, then the source data from the CRF should be 
transcribed into the patient’s notes with appropriate signature and date to provide a 
full audit trail. 
The investigator and study staff are responsible for maintaining a comprehensive and 
centralized filing system of all study-related, essential documentation (as outlined in 
the ICH Tripartite Guidelines for GCP Topic E6(R2)52, section 8.2), suitable for 
inspection at any time by representatives from GW and/or applicable Regulatory 
Authorities.  Elements should include: 


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• Patient files containing completed CRFs, ICFs and supporting copies of source 
documentation. 
• Study files containing the protocol with all amendments, IB, copies of 
pre-study documentation (see Section 15.4) and all correspondence to and 
from the EC/IRB and GW. 
• Proof of receipt, IMP accountability record, return of IMP for destruction, 
final IMP reconciliation statement and all drug-related correspondence. 
In addition, all original source documents supporting entries in the CRFs, diary data 
and electronic data captured by IVRS must be maintained and be readily available. 
Following completion or termination of a clinical study, GW will initiate proper 
archive of clinical study-related documentation and electronic records generated by 
the investigator and/or GW.  All clinical trial-related documents and electronic 
records will be retained within an archiving system for a period dependent upon need 
and for a minimum of 25 years.  Essential documents should be retained until at least 
two years after the last approval of a marketing application in an ICH region and until 
there are no pending or contemplated marketing applications in an ICH region, or 
until at least two years have elapsed since the formal discontinuation of clinical 
development of the IMP.  These documents should be retained for a longer period, 
however, if required by the applicable regulatory requirements61 or if needed by GW.  
GW will inform the investigators for each center in writing of the need for record 
retention.  No study document should be destroyed without prior written agreement 
between GW and the investigator.  Should the investigator wish to assign the study 
records to another party or move them to another location, he/she must notify GW in 
writing of the new responsible person and/or the new location. 
16.3 
Study Monitoring and Data Collection 
The GW representative and Regulatory Authority inspectors are responsible for 
contacting and visiting the investigator for the purpose of inspecting the facilities and, 
upon request, inspecting the various records of the study, e.g., CRFs and other 
pertinent data, provided that patient confidentiality is respected. 
The GW study monitor, or designee, is responsible for inspecting the CRFs and 
available IVRS/diary data at regular intervals throughout the study to verify 
adherence to the protocol, completeness, accuracy and consistency of the data and 
adherence to local regulations on the conduct of clinical research.  The study monitor 


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should have access to patient medical records and other study-related records needed 
to verify the entries in the CRFs. 
The investigator agrees to co-operate with the study monitor to ensure that any 
problems detected in the course of these monitoring visits are resolved. 
To ensure the quality of clinical data across all patients and centers, a clinical data 
management review will be performed on patient data received at GW or a contract 
research organization (CRO).  During this review, patient data will be checked for 
consistency, omissions and any apparent discrepancies.  In addition, the data will be 
reviewed for adherence to the protocol and FDA regulations57,58,59,68, ICH Tripartite 
Guidelines for GCP Topic E6(R2)52 and all other applicable regulatory requirements.   
To resolve any questions arising from the clinical data management review process, 
data queries and/or center notifications will be sent to the center for completion and 
then returned to GW or the CRO, as applicable. 
16.4 
Electronic Data collected by Interactive Voice Response System 
Source data for the assessments collected via IVRS will be managed by the service 
provider in accordance with ICH Tripartite Guidelines for GCP Topic E6(R2)52 and 
in adherence to a quality management system.  All data will be stored in a secure 
(e.g., redundant hardware, password control, limited physical access to servers), fully 
audit trailed environment with appropriate industry standard back-up and off-site 
storage practices. 
Access for patients providing assessments and investigators will be authenticated and 
meet industry standards and comply with the requirements outlined in the FDA Code 
of Federal Regulations Title 21, Part 11, Subpart B (Electronic Records)68.  
After database lock, all investigators will receive a certified copy of all IVRS 
assessment data.  These data will be in an agreed, read-only format with a covering 
letter explaining the content of the data, a quality statement from the IVRS provider 
and the investigator’s responsibilities. 
Regulatory and sponsor auditors will have the ability to review, but not modify, IVRS 
data via an agreed means of access. 
16.5 
Quality Assurance 
In accordance with the FDA regulations57,58,59,68, EU Clinical Trials Directive60/ICH 
Tripartite Guidelines for GCP Topic E6(R2)52 and the sponsor’s audit plans, 


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representatives from GW’s Clinical Quality Assurance Department may select this 
study for audit.  Inspection of center facilities, e.g., pharmacy, drug storage areas, 
laboratories, and review of study-related records will occur to evaluate the study 
conduct and compliance with the protocol, the EU Clinical Trials Directive60/ICH 
Tripartite Guidelines for GCP Topic E6 (R2)52 and applicable regulatory 
requirements. 
16.6 
Compensation 
GW will indemnify the investigator and the study center in the event of any claim in 
respect of personal injury arising due to a patient’s involvement in the study, 
providing that the study protocol has been adhered to.  This would include claims 
arising out of or relating to the administration of the IMP or any clinical intervention 
or procedure provided for or required by the protocol to which the clinical study 
patient would not otherwise have been exposed, providing there is no evidence of 
negligence on behalf of the investigator or their team.  GW will not be liable for any 
claims arising from negligence on the part of the investigator or their team. 
16.7 
Publication Policy 
GW recognizes that there is a responsibility under the regulatory guidelines to ensure 
that results of scientific interest arising from this clinical study are appropriately 
published and disseminated.  They will co-ordinate this dissemination and may solicit 
input and assistance from the chief/principal investigators.  A summary of the results 
of this study will be made available on http://www.clinicaltrials.gov, as required by 
U.S. Law. 
The raw data from this study may be obtained by the PIs or by their steering 
committee representatives on request.  Should they wish, PIs are allowed to conduct 
their own analyzes and are permitted to present such information along with methods 
and results of the clinical study at symposia, national or regional professional 
meetings and to publish it in theses or dissertations. 
All publications, e.g., manuscripts, abstracts, oral/slide presentations or book chapters 
based on this study, must be submitted to the GW Medical Writing Department and, 
as applicable, GW Publication Committee for corporate review before release.  To 
ensure adequate time for GW to make comments and suggestions where pertinent, all 
such material should be submitted to them at least 60 days prior to the date for 
submission for publication, public dissemination, or review by a publication 


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committee.  The PIs must then incorporate all reasonable comments made by GW into 
the publication. 
GW also reserves the right to delay the submission of such information by a period of 
up to six months from the date of first submission to them in order to allow them to 
take steps to protect proprietary information where applicable. 
16.8 
Intellectual Property Rights 
All Intellectual Property Rights owned by or licensed to either GW or the PIs, other 
than those arising from the clinical study, will remain their property.  All Intellectual 
Property Rights arising out of the clinical study will vest in or be exclusively licensed 
to GW and, as such, the PI should promptly disclose all knowledge to GW and refrain 
from using such knowledge without the prior written consent of GW. 
16.9 
Confidential Information 
GW and the PI should ensure that only personnel directly concerned with the study 
should be party to confidential information and that any information coming to either 
party about the other during the course of the study should be kept strictly confidential 
and should not be disclosed to any third party or made use of without the prior written 
consent of the other.  


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17 
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33 Hancock EC, Osborne JP, Edwards SW. Treatment of infantile spasms. Cochrane 
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47 Porter BE, Jacobson C. Report of a parent survey of cannabidiol-enriched 
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62 U.S. Food and Drug Administration guidance for clinical Investigators, Sponsors, 
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APPENDIX 1 
SCHEDULE OF ASSESSMENTS 
Blinded Phase 
Visit Number 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
 
11 
 
12 
(Tel.) 
Safety 
Calls* 
Day 
-35 
-28 
1 
15 
29 
43 
57 
71 
85 
113 
123 
151 
 
Visit Window 
 
±7 
+3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
+3 
+3 
 
Informed consent/assent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Eligibility Criteria 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Vital signs and BP 
X 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
 
Postural BP 
X 
 
X 
 
X 
 
 
 
 
 
 
 
 
Physical examination (including 
height and body weight) 
X 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
 
ECG 
X 
 
X§ 
X 
X 
X 
X 
 
X 
X 
X 
 
 
Clinical laboratory blood sampling  
X 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
 
Clinical laboratory IGF-1 testing 
 
 
X 
 
 
 
 
 
 
X 
 
 
 
Clinical laboratory urine sampling 
(dipstick urinalysis)  
X 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
 
Urine/serum THC screen 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy tests 
(if appropriate) 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
 


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Visit Number 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
 
11 
 
12 
(Tel.) 
Safety 
Calls* 
Day 
-35 
-28 
1 
15 
29 
43 
57 
71 
85 
113 
123 
151 
 
Visit Window 
 
±7 
+3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
+3 
+3 
 
Pharmacokinetic blood sampling♦  
 
 
X 
 
 
 
 
 
 
X 
 
 
 
AED concentration 
 
 
X 
 
X 
 
X 
 
X 
X 
 
 
 
TSC1 and TSC2 mutation status 
(if unknown and consent is given) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
AEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Inpatient epilepsy-related 
hospitalizations 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Suicidality/C-SSRS/Children’s 
C-SSRS 
X 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
 
Vineland-II 
 
 
X 
 
 
 
 
 
 
X 
 
 
 
SGIC/CGIC 
 
 
X 
 
 
 
 
 
 
X 
 
 
 
PGIC 
 
 
X 
 
 
 
 
 
 
X 
 
 
 
SGIC-SD/CGIC-SD 
 
 
X  
 
 
 
 
 
 
X 
 
 
 
QOLCE/QOLIE-31-P 
 
 
X 
 
 
 
 
 
 
X 
 
 
 
Wechsler Tests  
 
 
X 
 
 
 
 
 
 
X 
 
 
 
CBCL/ABCL 
 
 
X 
 
 
 
 
 
 
X 
 
 
 
SCQ 
 
 
X 
 
 
 
 
 
 
X 
 
 
 
Tanner Staging (where appropriate)  
 
 
X 
 
 
 
 
 
 
X 
 
 
 
Menstruation question (where 
appropriate) 
 
 
X 
 
 
 
 
 
 
X 
 
 
 


SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol V8 23Apr19 
 
Confidential 
Page 145 of 154 
Template: 231014.V1 
 
Visit Number 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
 
11 
 
12 
(Tel.) 
Safety 
Calls* 
Day 
-35 
-28 
1 
15 
29 
43 
57 
71 
85 
113 
123 
151 
 
Visit Window 
 
±7 
+3 
±3 
±3 
±3 
±3 
±3 
±3 
±3 
+3 
+3 
 
Patient IVRS and paper diary 
review (seizures, AE information, 
concomitant AEDs, rescue 
medication, IMP dosing) 
 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
 
IVRS and diary training 
 
X 
 
 
 
 
 
 
 
 
 
 
 
IMP dispensing 
 
 
X 
X 
X 
X 
X 
 
X 
X 
 
 
 
Collection of IMP 
 
 
 
X 
X 
X 
X 
 
X 
X 
X 
 
 
IMP compliance review 
 
 
 
X 
X 
X 
X 
 
X 
X 
X 
 
 
Study Medication Use and 
Behavior Survey 
 
 
 
 
 
 
 
 
 
X† 
 
 
*Telephone safety calls will be completed every two days during titration, one week after the end of titration and, for patients not entering the OLE, weekly from Visit 10 
to Visit 12. If the call falls on a weekend, it is permitted to schedule the call for the Friday before or Monday after the weekend instead. 
§ ECG must be re-assessed four hours (±30 minutes) post-dose. 
♦Only for patients weighing > 20 kg. 
†Performed at final dosing visit (End of Treatment/Withdrawal visit or End of Taper visit, as applicable) for patients 12 years of age and older only. 
 
 


SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol V8 23Apr19 
 
Confidential 
Page 146 of 154 
Template: 231014.V1 
 
Open-label Extension 
Visit Number 
 
B1 
B2 
B3 
B4 
Re-supply 
Visit  
B5 
 
B6 
Re-supply 
Visit  
B7 
 
B8 
Re-supply 
Visit  
B9 
End of 
Treatment 
B10 
End of 
Taper 
B11 
Post-taper 
Safety 
Telephone 
Call  
B12 
Follow up 
(Tel) 
Safety 
Calls* 
Day 
1 
15 
36 
92 
141 
183 
232 
274 
323 
365 
375 
389 
403 
 
Visit Window 
 
±3 
±3 
±3 
±7 
±7 
±7 
±7 
±7 
±7 
+3 
±3 
+3 
 
Informed consent/assent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vital signs and BP 
X 
X 
X 
X 
 
X 
 
X 
 
X 
X 
 
 
 
Postural blood pressure 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Physical examination 
(including height and body 
weight) 
X 
X 
X 
X 
 
X 
 
X 
 
X 
X 
 
 
 
ECG 
X 
X 
X 
X 
 
X 
 
X 
 
X 
X 
 
 
 
Clinical laboratory blood 
sampling  
X 
X 
X 
X 
 
X 
 
X 
 
X 
X 
 
 
 
Clinical laboratory IGF-1 
testing 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
Clinical laboratory urine 
sampling (dipstick urinalysis)  
X 
X 
X 
X 
 
X 
 
X 
 
X 
X 
 
 
 
Pregnancy tests (if appropriate) 
X 
 
 
X 
 
X 
 
X 
 
X 
 
 
 
 
AED concentration 
 
X 
X 
X 
 
X 
 
X 
 
X 
 
 
 
 
AEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Inpatient epilepsy-related 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 


SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol V8 23Apr19 
 
Confidential 
Page 147 of 154 
Template: 231014.V1 
 
Visit Number 
 
B1 
B2 
B3 
B4 
Re-supply 
Visit  
B5 
 
B6 
Re-supply 
Visit  
B7 
 
B8 
Re-supply 
Visit  
B9 
End of 
Treatment 
B10 
End of 
Taper 
B11 
Post-taper 
Safety 
Telephone 
Call  
B12 
Follow up 
(Tel) 
Safety 
Calls* 
Day 
1 
15 
36 
92 
141 
183 
232 
274 
323 
365 
375 
389 
403 
 
Visit Window 
 
±3 
±3 
±3 
±7 
±7 
±7 
±7 
±7 
±7 
+3 
±3 
+3 
 
hospitalizations 
Suicidality/C-SSRS/Children’s 
C-SSRS 
X 
X 
X 
X 
 
X 
 
X 
 
X 
X 
 
 
 
Vineland-II 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
SGIC/CGIC 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
PGIC 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
SGIC-SD/CGIC-SD 
X 
 
 
X 
 
X 
 
X 
 
X 
 
 
 
 
QOLCE/QOLIE-31-P 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
Wechsler Tests  
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
CBCL/ABCL 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
SCQ 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
Tanner Staging (where 
appropriate)  
X 
 
 
 
 
 
 
 
 
X 
 
 
 
 
Menstruation question (where 
appropriate) 
X 
 
 
 
 
 
 
 
 
X 
 
 
 
 
Patient IVRS and paper diary 
review (seizures, AE 
information, concomitant 
AEDs, rescue medication, IMP 
dosing) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 


SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol V8 23Apr19 
 
Confidential 
Page 148 of 154 
Template: 231014.V1 
 
Visit Number 
 
B1 
B2 
B3 
B4 
Re-supply 
Visit  
B5 
 
B6 
Re-supply 
Visit  
B7 
 
B8 
Re-supply 
Visit  
B9 
End of 
Treatment 
B10 
End of 
Taper 
B11 
Post-taper 
Safety 
Telephone 
Call  
B12 
Follow up 
(Tel) 
Safety 
Calls* 
Day 
1 
15 
36 
92 
141 
183 
232 
274 
323 
365 
375 
389 
403 
 
Visit Window 
 
±3 
±3 
±3 
±7 
±7 
±7 
±7 
±7 
±7 
+3 
±3 
+3 
 
IVRS and diary training 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
IMP dispensing 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Collection of IMP 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
IMP compliance review 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Study Medication Use and 
Behavior Survey 
 
 
 
 
 
 
 
 
 
X† 
 
 
 
*Telephone safety calls will be completed every two days during the blinded transition, titration and one week after the end of titration. If the call falls on a weekend, it is 
permitted to schedule the call for the Friday before or Monday after the weekend instead. 
†Performed at final dosing visit (End of Treatment/Withdrawal visit or End of Taper visit, as applicable) for patients 12 years of age and older only.


SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol V8 23Apr19 
 
Confidential 
Page 149 of 154 
Template: 231014.V1 
 
APPENDIX 2 
TANNER STAGING 
(Reproduced with permission from the New England Journal of Medicine)55. 
The following is to be completed for all female adolescent patients (i.e., 10 to less 
than 18 years of age at the time of signing the informed consent/assent form, or earlier 
if clinically indicated by onset of menarche or other signs of precocious puberty).  
Female Development & Pubic Hair 
 
 
Please check the box next to the most appropriate stage; in the event that qualifying 
characteristics are not within the same stage, defer to the lesser stage as the overall 
Tanner Score. 
Tanner Stage 1 (Prepubertal, typically 10 years and younger) 
• No glandular tissue; areola follows the skin contours of the chest. 
• No pubic hair at all. 
Tanner Stage 2 (10–11.5 years) 
• Breast bud forms, with small area of surrounding glandular tissue; areola 
begins to widen. † 


SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol V8 23Apr19 
 
Confidential 
Page 150 of 154 
Template: 231014.V1 
 
• Small amount of long, downy hair with slight pigmentation on the labia 
majora. 
Tanner Stage 3 (11.5–13 years) 
• Breast begins to become more elevated, and extends beyond the borders of the 
areola, which continues to widen but remains in contour with surrounding 
breast. 
• Hair becomes more coarse and curly and begins to extend laterally. 
Tanner Stage 4 (13–15 years) 
• Increased breast size and elevation; areola and papilla form a secondary 
mound projecting from the contour of the surrounding breast. 
• Adult-like hair quality, extending across pubis but sparing medial thighs. 
Tanner Stage 5 (15+ years) 
• Breast reaches final adult size; areola returns to contour of the surrounding 
breast, with a projecting central papilla. 
• Hair extends to medial surface of the thighs. 
The following is to be completed for all male adolescent patients (i.e., 12 to less than 
18 years of age at the time of signing the informed consent/assent form). 
Male Genital Development & Pubic Hair 
 
 
Please check the box next to the most appropriate stage. 
Tanner Stage 1 (Prepubertal, typically 9 years and younger) 
• Testicular volume less than 1.5 mL; small penis of 3 cm or less. 
• No pubic hair at all. 
Tanner Stage 2 (9–11 years) 


SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol V8 23Apr19 
 
Confidential 
Page 151 of 154 
Template: 231014.V1 
 
• Testicular volume between 1.6 and 6 mL; skin on scrotum thins, reddens and 
enlarges; penis length unchanged. 
• Small amount of long, downy hair with slight pigmentation at the base of the 
penis and scrotum. 
Tanner Stage 3 (11–12.5 years) 
• Testicular volume between 6 and 12 mL; scrotum enlarges further; penis 
begins to lengthen to about 6 cm. 
• Hair becomes more coarse and curly and begins to extend laterally. 
Tanner Stage 4 (12.5–14 years) 
• Testicular volume between 12 and 20 mL; scrotum enlarges further and 
darkens; penis increases in length to 10 cm and circumference. 
• Adult-like hair quality, extending across pubis but sparing medial thighs. 
Tanner Stage 5 (14+ years) 
• Testicular volume greater than 20 mL; adult scrotum and penis of 15 cm in 
length. 
• Hair extends to medial surface of the thighs. 


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SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol V8 23Apr19 
 
Confidential 
Page 153 of 154 
Template: 231014.V1 
 
APPENDIX 4 
IVRS CALLS FOLLOWING END OF 
TREATMENT/WITHDRAWAL 
Timings of IVRS calls to be made by the patient/caregiver following the date of End 
of Treatment/Withdrawal in the blinded or OLE phase are summarized overleaf. 


SPONSOR: GW RESEARCH LIMITED 
 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol V8 23Apr19 
 
Confidential 
Page 154 of 154 
Template: 231014.V1 
 
Relative Day 
Blinded Phasea 
OLE Phase 
IMP Not Tapered 
IMP Tapered 
IMP Not Tapered 
IMP Tapered 
Date of End of 
Treatment/Withdrawalb 
X 
X 
 
X 
+1 
 
X 
 
 
+2 
 
X 
 
 
+3 
 
X 
 
 
+4 
 
X 
 
 
+5 
 
X 
 
 
+6 
 
X 
 
 
+7 
 
X 
 
X 
+8 
 
X 
 
 
+9 
 
X 
 
 
+10 
 
 
 
 
+11 
 
 
 
 
+12 
 
 
 
 
+13 
 
 
 
 
+14 
 
 
 
 
+15 
 
 
 
 
+16 
 
 
 
 
+17 
 
 
 
 
+18 
 
 
 
 
+19 
 
 
 
 
+20 
 
 
 
 
+21 
 
 
 
 
+22 
 
 
 
 
+23 
 
 
 
 
+24 
 
 
 
 
+25 
 
 
 
 
+26 
 
 
 
 
+27 
X 
 
X 
 
+28 
 
 
 
 
+29 
 
 
 
 
+30 
 
 
 
 
+31 
 
 
 
 
+32 
 
 
 
 
+33 
 
 
 
 
+34 
 
 
 
 
+35 
 
 
 
 
+36 
 
 
 
 
+37 
 
X 
 
X 
+38 
 
 
 
 
+39 
 
 
 
 
+40 
 
 
 
 
Note: Gray shading denotes visit windows. 
a Only for patients who do not enter the OLE on the day of Visit 10 or for those who withdraw 
early from the blinded phase. 
b Date of End of Treatment/Withdrawal should match the date reported in interactive web/voice 
response system. 
 


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SPONSOR: GW RESEARCH LIMITED 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Amendment 7 V1 23Apr19 
 
Confidential 
Page 2 of 13 
Clinical Protocol Amendment Template 
V1, 24Sep15 
1 
PROTOCOL SYNOPSIS 
Trial Title 
A double-blind, randomized, placebo-controlled study to 
investigate the efficacy and safety of cannabidiol (GWP42003-P, 
CBD) as add-on therapy in patients with tuberous sclerosis 
complex who experience inadequately-controlled seizures. 
Indication 
Seizures* in patients with tuberous sclerosis complex (TSC). 
*Seizures include: focal motor seizures without impairment of 
consciousness or awareness; focal seizures with impairment of 
consciousness or awareness; focal seizures evolving to bilateral 
generalized convulsive seizures and generalized seizures 
(tonic-clonic, tonic, clonic or atonic) that are countable. 
Trial Design 
This multicenter study consists of a randomized, 
placebo-controlled, double-blind phase followed by an 
open-label extension (OLE) phase. 
Blinded Phase: 
The blinded phase of the study is a randomized, double-blind, 
parallel-group, 16-week comparison of two doses of GWP42003-P 
versus placebo.  Patients will complete a 1-week screening period 
and a 4-week baseline period before they are randomized to receive 
25 mg/kg/day GWP42003-P, 50 mg/kg/day GWP42003-P or 
equivalent volumes of placebo.  Randomization will be stratified 
by age according to the following ranges: 1–6,  
7–11, 12–17 years and 18+ years.  Patients will begin a 4-week 
dose escalation period, titrating up to their assigned dose, before 
continuing on a stable dose of blinded investigational medicinal 
product (IMP) for 12 weeks.  
Dose escalation for each patient is subject to the investigator’s 
assessment of safety and tolerability.  If a dose becomes poorly 
tolerated, the investigator may consider temporarily or permanently 
reducing the dose for the remainder of the study. 
Clinic visits will occur for screening (Day −35), baseline 
(Day −28), randomization (Day 1) and, on Days 15 and 29 during 
titration and on Days 43, 57, 71 (telephone) and 85 until the end of 
treatment (Day 113).  Safety telephone calls will be completed 
every two days during titration, one week after the end of titration 
and, for patients not entering the OLE, weekly from Visit 10 to 
Visit 12.  If the call falls on a weekend, it is permitted to schedule 
the call for the Friday before or Monday after the weekend instead. 
Patients will be required to perform daily interactive voice 
response system (IVRS) telephone calls to record seizure 
information.  They will also complete a paper diary daily with 
information about their IMP and concomitant AED administration.  
Following completion of the blinded phase, patients will be invited 


SPONSOR: GW RESEARCH LIMITED 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Amendment 7 V1 23Apr19 
 
Confidential 
Page 3 of 13 
Clinical Protocol Amendment Template 
V1, 24Sep15 
to continue to receive GWP42003-P in an OLE.  
Those patients opting not to enter the OLE will complete a 10-day 
taper period (down-titrating 10% per day for 10 days).  
Open-label Extension Transition: 
In order to maintain consistent exposure to IMP and maintain the 
integrity of the blind, patients will enter a 2-week blinded transition 
to the OLE.  OLE IMP will be titrated up to 25 mg/kg/day whilst 
blinded IMP is simultaneously tapered down to zero.  All patients 
will complete the transition and enter the OLE taking 
25 mg/kg/day GWP42003-P:  
• Patients from the placebo group will titrate up to 25 mg/kg/day 
GWP42003-P. 
• Patients from the 25 mg/kg/day GWP42003-P group will 
continue to take 25 mg/kg/day GWP42003-P. 
• Patients from the 50 mg/kg/day GWP42003-P group will taper 
down (10% per day) to 25 mg/kg/day GWP42003-P. 
Safety telephone calls will be completed every two days 
throughout the OLE transition.  If the call falls on a weekend, it is 
permitted to schedule the call for the Friday before or Monday after 
the weekend instead. 
Open-label Extension: 
The OLE consists of a 3-week titration period followed by a 
maintenance period and a 10-day taper period.  The initial OLE 
period will last for a maximum of 1 year. 
Following titration according to the titration schedule, patients will 
continue with their optimal GWP42003-P dose.  However, 
investigators may decrease the dose if a patient experiences 
intolerance, or increase the dose to a maximum of 50 mg/kg/day if 
required for better seizure control, until the optimal dose is found.  
Dose increases above 25 mg/kg/day are recommended to be done 
slowly, with maximum increments of 2.5 mg/kg/day every 
two days.  Patients whose dose has been decreased can have their 
dose increased again provided there is adequate tolerance.  Safety 
telephone calls will be completed every two days throughout the 
OLE titration and one week after the end of titration.  If the call 
falls on a weekend, it is permitted to schedule the call for the 
Friday before or Monday after the weekend instead.  If seizure 
freedom is achieved with use of GWP42003-P during the study, the 
investigator should consider reducing the dose of concomitant 
AEDs after six months of seizure freedom. 
Sponsor 
GW Research Ltd 
Sovereign House 
Vision Park 
Chivers Way 


SPONSOR: GW RESEARCH LIMITED 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Amendment 7 V1 23Apr19 
 
Confidential 
Page 4 of 13 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Histon 
Cambridge CB24 9BZ 
United Kingdom 
 


SPONSOR: GW RESEARCH LIMITED 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Amendment 7 V1 23Apr19 
 
Confidential 
Page 5 of 13 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Table of Contents 
Title Page ................................................................................................... 1 
1 
PROTOCOL SYNOPSIS ................................................................ 2 
Table of Contents ...................................................................................... 5 
List of Appendices..................................................................................... 6 
2 
RATIONALE ................................................................................... 7 
2.1 
Change in Hierarchy for Analysis ................................................................. 7 
2.2 
Minor Corrections and Clarifications ............................................................ 7 
3 
IMPLEMENTATION OF THE AMENDMENT ......................... 8 
4 
PRESENTATION OF AMENDED TEXT ................................... 9 
5 
REFERENCES .............................................................................. 11 
 


SPONSOR: GW RESEARCH LIMITED 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Amendment 7 V1 23Apr19 
 
Confidential 
Page 6 of 13 
Clinical Protocol Amendment Template 
V1, 24Sep15 
List of Appendices 
APPENDIX 1 
AMENDED TABLE ................................................................ 12 


SPONSOR: GW RESEARCH LIMITED 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Amendment 7 V1 23Apr19 
 
Confidential 
Page 7 of 13 
Clinical Protocol Amendment Template 
V1, 24Sep15 
2 
RATIONALE 
This clinical protocol amendment 7 (will be incorporated into the Protocol creating 
Clinical Protocol Version 8 Date 23 April 2019) addresses the following issue(s): 
2.1 
Change in Hierarchy for Analysis 
Following review of the original hierarchy for analysis, the Global Impression of 
Change (GIC) and total seizure endpoints were deemed of lower critical importance 
compared with the TSC-associated seizure endpoints.  Therefore, the GIC and total 
seizure endpoints were moved down in the hierarchy so that all TSC-associated 
seizure endpoints are tested first. 
2.2 
Minor Corrections and Clarifications 
• ICH definition changed on 23 October 2015 from ‘International Conference 
on Harmonisation’ to ‘International Council for Harmonisation’.  References 
to ICH updated accordingly throughout. 


SPONSOR: GW RESEARCH LIMITED 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Amendment 7 V1 23Apr19 
 
Confidential 
Page 8 of 13 
Clinical Protocol Amendment Template 
V1, 24Sep15 
3 
IMPLEMENTATION OF THE AMENDMENT 
The changes detailed in this amendment will be issued as Clinical Protocol Version 8, 
Date 23 April 2019.  It will be kept in the trial master file at GW as well as in each 
investigational center file and, if applicable, pharmacy site file. 
 


SPONSOR: GW RESEARCH LIMITED 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Amendment 7 V1 23Apr19 
 
Confidential 
Page 9 of 13 
Clinical Protocol Amendment Template 
V1, 24Sep15 
4 
PRESENTATION OF AMENDED TEXT 
The text will be amended as follows: 
Revised Protocol 
Section Number, 
Heading and Page 
Number 
Original Wording from Clinical Protocol Version 7, 
Date 06 September 2018 
(Deleted wording is struck through and in bold) 
Revised Wording from Clinical Protocol 
Amendment 7 
[Clinical Protocol Version 8, 
Date 23 April 2019] 
(Revised wording is underscored and in bold)  
Rationale for the 
amendment 
Investigator 
Agreement 
p. 2 
(…) 
I agree to comply with applicable regulatory 
requirement(s); the U.S. Food and Drug Administration 
(FDA) regulations relating to good clinical practice 
(GCP) and clinical trials, the European Union (EU) 
Clinical Trials Directive (2001/20/EC), the EU Good 
Clinical Practice/GCP Directive (2005/28/EC) and 
subsequent applicable regulatory/statutory instruments, 
or the International Conference on Harmonisation 
Tripartite Guidelines for GCP where the EU Clinical 
Trials and GCP Directives do not apply, and to complete 
Form FDA 1572, if required. 
(…) 
I agree to comply with applicable regulatory 
requirement(s); the U.S. Food and Drug Administration 
(FDA) regulations relating to good clinical practice 
(GCP) and clinical trials, the European Union (EU) 
Clinical Trials Directive (2001/20/EC), the EU Good 
Clinical Practice/GCP Directive (2005/28/EC) and 
subsequent applicable regulatory/statutory instruments, 
or the International Council for Harmonisation Tripartite 
Guideline for GCP where the EU Clinical Trials and 
GCP Directives do not apply, and to complete Form FDA 
1572, if required. 
See Section 2.2 
List of 
Abbreviations 
ICH 
International Conference of Harmonisation 
 
ICH 
International Council for Harmonisation 
 
See Section 2.2 


SPONSOR: GW RESEARCH LIMITED 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Amendment 7 V1 23Apr19 
 
Confidential 
Page 10 of 13 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Revised Protocol 
Section Number, 
Heading and Page 
Number 
Original Wording from Clinical Protocol Version 7, 
Date 06 September 2018 
(Deleted wording is struck through and in bold) 
Revised Wording from Clinical Protocol 
Amendment 7 
[Clinical Protocol Version 8, 
Date 23 April 2019] 
(Revised wording is underscored and in bold)  
Rationale for the 
amendment 
p.32 
Section 9.2.1 
Informed 
Consent/Assent 
p. 83 
(...) 
By signing the ICF, the witness attests that the 
information in the ICF was accurately explained to and 
apparently understood by the patient and that informed 
consent was freely given by the patient (as outlined in the 
International Conference on Harmonisation [ICH] 
Tripartite Guideline for GCP Topic E6(R2)52, 
section 4.8.9) 
(...) 
By signing the ICF, the witness attests that the 
information in the ICF was accurately explained to and 
apparently understood by the patient and that informed 
consent was freely given by the patient (as outlined in the 
International Council for Harmonisation [ICH] Tripartite 
Guideline for GCP Topic E6(R2)52, section 4.8.9). 
See Section 2.2 
Section 13.6 
Endpoints and 
Statistical Methods 
Table 13.6-1 
p. 115 
<See APPENDIX 1 for changes to the Table> 
 
<See APPENDIX 1 for changes to the Table> 
 
See Section 2.1 
 


SPONSOR: GW RESEARCH LIMITED 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Amendment 7 V1 23Apr19 
 
Confidential 
Page 11 of 13 
Clinical Protocol Amendment Template 
V1, 24Sep15 
5 
REFERENCES 
N/A. 


SPONSOR: GW RESEARCH LIMITED 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Amendment 7 V1 23Apr19 
 
Confidential 
Page 12 of 13 
Clinical Protocol Amendment Template 
V1, 24Sep15 
 APPENDIX 1 
AMENDED TABLE 
Original Table from Clinical Protocol Version 7, Date 06 September 2018 
(Deleted wording is struck through and in bold; deleted lines are in bold and dotted) 
 
 
Table 13.6-1 
Hierarchy for Analysis 
Test 
Endpoint 
Treatment Comparison 
1 
Change from baseline in number of TSC-
associated seizures 
25 mg/kg/day GWP42003-P vs. Placebo 
2 
50% responder analysis 
25 mg/kg/day GWP42003-P vs. Placebo 
3 
Change in CGIC/SGIC 
25 mg/kg/day GWP42003-P vs. Placebo 
4 
Change from baseline in total seizures 
25 mg/kg/day GWP42003-P vs. Placebo 
5 
Change from baseline in number of TSC-
associated seizures 
50 mg/kg/day GWP42003-P vs. Placebo 
6 
50% responder analysis 
50 mg/kg/day GWP42003-P vs. Placebo 
7 
Change in CGIC/SGIC 
50 mg/kg/day GWP42003-P vs. Placebo 
8 
Change from baseline in total seizures 
50 mg/kg/day GWP42003-P vs. Placebo 


SPONSOR: GW RESEARCH LIMITED 
Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Amendment 7 V1 23Apr19 
 
Confidential 
Page 13 of 13 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Revised Figures from Clinical Protocol Version 8, Date 14 April 2019 
(Revised wording is underscored and in bold; revised lines are in bold) 
 
Table 13.6-1 
Hierarchy for Analysis 
Test 
Endpoint 
Treatment Comparison 
1 
Change from baseline in number of TSC-
associated seizures 
25 mg/kg/day GWP42003-P vs. Placebo 
2 
50% responder analysis 
25 mg/kg/day GWP42003-P vs. Placebo 
3 
Change from baseline in number of TSC-
associated seizures 
50 mg/kg/day GWP42003-P vs. Placebo 
4 
50% responder analysis 
50 mg/kg/day GWP42003-P vs. Placebo 
5 
Change in CGIC/SGIC 
25 mg/kg/day GWP42003-P vs. Placebo 
6 
Change from baseline in total seizures 
25 mg/kg/day GWP42003-P vs. Placebo 
7 
Change in CGIC/SGIC 
50 mg/kg/day GWP42003-P vs. Placebo 
8 
Change from baseline in total seizures 
50 mg/kg/day GWP42003-P vs. Placebo 


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Table 8.1.2-2                 Blinded Transition 
 
Patients randomised to 
25 mg/kg/day group 
Patients randomised to 
50 mg/kg/day group 
Patients randomised to 
placebo group 
Day Blinded 
Transition/OLE 
Blinded 
Open 
label 
Blinded 
Open 
label 
Placebo 
Open 
label 
1 
25 
0 
50 
0 
0 
0 
2 
22.5 
0 
45 
0 
0 
0 
3 
20 
5 
40 
5 
0 
5 
4 
17.5 
5 
35 
5 
0 
5 
5 
15 
10 
30 
10 
0 
10 
6 
12.5 
10 
25 
10 
0 
10 
7 
10 
15 
20 
15 
0 
15 
8 
7.5 
15 
15 
15 
0 
15 
9 
5 
20 
10 
20 
0 
20 
10
2.5 
20 
5 
20 
0 
20 
11
0 
25 
0 
25 
0 
25 
12
0 
25 
0 
25 
0 
25 
13
0 
25 
0 
25 
0 
25 
14
0 
25 
0 
25 
0 
25 


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OLE Day 
Blinded Dose 
(mg/kg/day) 
15 (Visit B2) 
26.25 
16
27.5 
17
30
18
30 
19
32.5 
20
32.5 
21
35 
22
35 
23
37.5 
24
37.5 
25
40 
26
40 
27
42.5 
28
42.5 
29
45
30
45 
31
47.5 
32
47.5 
33
50 
34
50 
35
50 
36 (Visit B3) 
50 


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Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
Confidential 
Page 3 of 17 
Clinical Protocol Annex Template 
V1, 24Sep15 
Table of Contents 
Title Page ........................................................................................................ 1 
Table of Contents ........................................................................................... 3 
List of Abbreviations ..................................................................................... 4 
Definition of Terms........................................................................................ 5 
1 
RATIONALE ........................................................................................ 6 
2 
SUMMARY OF THE ANNEX ........................................................... 6 
3 
TREATMENT SCHEMATIC DIAGRAM ....................................... 7 
4 
DESIGN AND PROCEDURES .......................................................... 8 
4.1 
Visit B10 (Week 52) ........................................................................................... 8 
4.2 
Resupply Visits B13 (Week 61), B14 (Week 70), B16 (Week 87), 
B17 (Week 96), B19 (Week 113), B20 (Week 122), B22 (Week 139), 
B23 (Week 148), B25 (Week 165), B26 (Week 174), B28 (Week 191), 
and B29 (Week 200) ........................................................................................... 8 
4.3 
Assessment Visits B15 (Week 78), B18 (Week 104), B21 (Week 130), 
B24 (Week 156), and B27 (Week 182) .............................................................. 9 
4.4 
End of Treatment/Withdrawal Visit .................................................................. 10 
4.5 
End of Taper Visit ............................................................................................. 12 
4.6 
Safety Telephone Call ....................................................................................... 13 
4.7 
Follow-up Visit ................................................................................................. 13 
5 
INFORMED CONSENT/ASSENT ................................................... 14 
6 
DATA ANALYSIS ............................................................................. 14 
6.1 
Patients to Analyze ........................................................................................... 14 
7 
IMPLEMENTATION OF THE ANNEX ........................................ 14 
APPENDIX 1 
SCHEDULE OF ASSESSMENTS ................................. 15 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
Confidential 
Page 4 of 17 
Clinical Protocol Annex Template 
V1, 24Sep15 
List of Abbreviations 
ABCL 
Adult Behavior Checklist 
AE 
Adverse event 
AED 
Antiepileptic drug 
CBCL 
Child Behavior Checklist 
CBD 
Cannabidiol 
CGIC 
Caregiver Global Impression of Change 
CGIC-SD 
Caregiver Global Impression of Change in Seizure Duration 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
ECG 
12-lead electrocardiogram 
EU 
European Union 
FDA 
US Food and Drug Administration 
GCP 
Good clinical practice 
GW 
GW Research Ltd 
IGF-1 
Insulin-like growth factor-1 
IMP 
Investigational medicinal product 
IVRS 
Interactive voice response system 
OLE 
Open-label extension 
PGIC 
Physician Global Impression of Change 
QOLCE 
Quality of Life in Childhood Epilepsy 
QOLIE-31-P 
Quality of Life in Epilepsy 
SCQ 
Social Communication Questionnaire 
SGIC 
Subject Global Impression of Change 
SGIC-SD 
Subject Global Impression of Change in Seizure Duration 
TSC 
Tuberous sclerosis complex 
 
(continued) 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
Confidential 
Page 5 of 17 
Clinical Protocol Annex Template 
V1, 24Sep15 
US 
United States 
Vineland-II 
Vineland Adaptive Behavior Scales, Second Edition 
 
Definition of Terms 
Term 
Definition 
End of trial 
Last patient last visit or last contact, whichever occurs last. 
Enrolled patient 
Any patient who has provided written informed 
consent/assent to take part in the trial. 
Investigational medicinal 
product 
Term used to describe both investigational active product 
and reference therapy (placebo). 
Investigator 
Trial principal investigator or a formally delegated study 
physician. 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
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Page 6 of 17 
Clinical Protocol Annex Template 
V1, 24Sep15 
1 
RATIONALE 
Trial GWEP1521 consists of a randomized, parallel-group, 16-week double-blind-phase 
comparing 2 doses of GWP42003-P with placebo, followed by a 1-year open-label 
extension (OLE) phase.  To ensure continued access to GWP42003-P prior to approval, 
the OLE phase will be extended to a total of 4 years in duration in the United States (US).  
Patients will complete the OLE phase when GWP42003-P is approved in tuberous 
sclerosis complex (TSC) and is commercially available to the patient, or after a maximum 
of 4 years of OLE treatment, whichever occurs first.   
2 
SUMMARY OF THE ANNEX 
Patients will complete the first year of the OLE at Visit B10 and enter a second year of 
OLE treatment.  Patients completing a second year of OLE treatment will enter a third 
year of OLE treatment.  Patients who complete OLE year 3 may enter a fourth year of 
OLE treatment.  Dosing will remain consistent and there is no requirement for dose 
adjustment or further titration upon entry into years 2, 3, or 4. 
Assessment visits have been added at Week 78, Week 104, Week 130, Week 156, and 
Week 182 (relative to Visit B1).  Investigational medicinal product (IMP) dispensing 
visits have also been added between assessment visits in years 2, 3, and 4 to ensure 
resupply volumes are manageable for both patients and dispensing staff.  Attendance of 
the patient is not required for the dispensing visits provided the primary caregiver is able 
to attend.  However, it is preferred that the patient attend where possible. 
Patients will complete the OLE phase when GWP42003-P is approved in TSC and is 
commercially available to the patient, or after a maximum of 4 years of OLE treatment, 
whichever occurs first.  Following completion of the OLE, patients who do not 
immediately continue to use commercial GWP42003-P will commence a 10-day taper 
period (tapering 10% per day) before attending an End of Taper visit.  A safety follow-up 
telephone call will be completed 2 weeks after the End of Taper visit and a safety 
Follow-up visit will be completed 4 weeks after the End of Taper visit.


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
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Page 7 of 17 
Clinical Protocol Annex Template 
V1, 24Sep15 
3 
TREATMENT SCHEMATIC DIAGRAM 
 
 
a End of Treatment/Withdrawal Visit will occur: 1) following early withdrawal from the trial; 2) in place of the next scheduled clinic visit (assessment or 
resupply) when GWP42003-P is approved in TSC and is commercially available to the patient; or 3) after a maximum of 4 years of OLE treatment 
(i.e., 208 weeks [±7 days] from Visit B1); whichever occurs first. 
b Only required for patients who withdraw from the trial or complete treatment but do not immediately continue to use commercial GWP42003-P. 
c Safety Telephone Call must be made 2 weeks (+3 days) after the patient’s last dose of IMP. 
d This must be made 4 weeks (+3 days) after the patient’s last dose of IMP and can be conducted by telephone. 
e Visits B13, B14, B16, B17, B19, B20, B22, B23, B25, B26, B28, and B29 – Resupply visits (±7 days). 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
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Clinical Protocol Annex Template 
V1, 24Sep15 
4 
DESIGN AND PROCEDURES 
Patients and their parent(s)/legal representative will be invited to participate in years 2, 3, 
and 4 of the OLE when they reach Visit B10 of the OLE phase.  They will be issued with 
additional OLE patient information and informed assent or the patient/parent(s)/legal 
representative information and informed consent (as applicable).  Following adequate 
time to discuss the additional visits with the investigator, nurse, relatives or caregiver, 
patients/parent(s)/legal representatives who provide written informed consent/assent at 
Visit B10 will continue in the OLE. 
Patients will continue to make weekly interactive voice response system (IVRS) diary 
calls throughout their second, third, and fourth years of OLE participation. 
4.1 
Visit B10 (Week 52) 
In addition to the visit schedule outlined in Section 9.1.2.10 of the main protocol, patients 
treated in the US who provide written informed consent/assent (see Section 5) will 
receive sufficient open-label IMP for 9 weeks’ home dosing and will be instructed to 
maintain consistent dosing.  An additional dose calculator and paper diary will be issued, 
and patients will be trained on their appropriate use. 
The Study Medication Use and Behavior Survey should not be administered at Visit B10 
for patients entering the second year of the OLE.  The investigator must record the 
patient’s attendance at the visit and confirm their continued participation. 
4.2 
Resupply Visits B13 (Week 61), B14 (Week 70), B16 (Week 87), 
B17 (Week 96), B19 (Week 113), B20 (Week 122), B22 (Week 139), 
B23 (Week 148), B25 (Week 165), B26 (Week 174), B28 (Week 191), 
and B29 (Week 200) 
Visits B13, B14, B16, B17, B19, B20, B22, B23, B25, B26, B28, and B29 will occur 61, 
70, 87, 96, 113, 122, 139, 148, 165, 174, 191, and 200 weeks after Visit B1, respectively.  
A visit window of ±7 days from the scheduled visit date is permitted, but it is preferred 
that the visit is performed on the scheduled visit day where possible. 
Attendance of the patient is not required for resupply visits provided the primary 
caregiver is able to attend.  However, it is preferred that the patient attend where possible. 
Each visit will comprise a review of concomitant medications (including antiepileptic 
drugs [AEDs]), epilepsy-related hospitalizations and adverse events (AEs). 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
Confidential 
Page 9 of 17 
Clinical Protocol Annex Template 
V1, 24Sep15 
The investigator must assess adherence to the dosing regimen by reviewing the patient’s 
diary and IVRS data, record the patient’s/caregiver’s attendance at the visit, and confirm 
the outcome of the visit. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  Patients/caregivers will then receive sufficient IMP until the next 
scheduled visit. 
4.3 
Assessment Visits B15 (Week 78), B18 (Week 104), 
B21 (Week 130), B24 (Week 156), and B27 (Week 182) 
Visits B15, B18, B21, B24, and B27 will occur 78, 104, 130, 156, and 182 weeks after 
Visit B1, respectively.  A visit window of ±7 days from the scheduled visit date is 
permitted, but it is preferred that the visit is performed on the scheduled visit day where 
possible. 
The following assessments will be made at each visit: 
• Concomitant medications (including AEDs) 
• Physical examination (including height and body weight) 
• 12-lead electrocardiogram (ECG) 
• Vital signs 
• Epilepsy-related hospitalizations 
• AEs 
• Subject Global Impression of Change in Seizure Duration (SGIC-SD)/Caregiver 
Global Impression of Change in Seizure Duration (CGIC-SD) 
• Suicidality, assessed in accordance with Section 9.2.12.8 of the main protocol 
At each assessment visit, clinical laboratory samples (blood and urine [where possible]), 
including a pregnancy test if appropriate (using both a serum sample and a urine 
dipstick), will be taken for hematology, biochemistry, urinalysis, and determination of 
serum insulin-like growth factor-1 (IGF-1) levels (for patients less than 18 years of age) 
to be performed by the central laboratory.  Provided that the risk/benefit outcome is 
favorable in the investigator’s opinion, prior to the first daily dose of IMP, a blood 
sample will be taken for analysis of plasma concentrations of concomitant AEDs. 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
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Page 10 of 17 
Clinical Protocol Annex Template 
V1, 24Sep15 
The investigator must assess adherence to the dosing regimen by reviewing the patient’s 
diary and IVRS data, record the patient’s attendance at the visit, and confirm the outcome 
of the visit. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  Patients/caregivers will then receive sufficient IMP until the next 
scheduled visit. 
In addition to the above, the following assessments will be made at Visit B18 and 
Visit B24: 
• Details of menstruation (for females) 
• Tanner staging (patients aged 10–17 [inclusive] only) 
• Quality of Life in Childhood Epilepsy (QOLCE)/Quality of Life in Epilepsy 
(QOLIE-31-P) 
• Subject Global Impression of Change (SGIC)/Caregiver Global Impression of 
Change (CGIC) 
• Physician Global Impression of Change (PGIC) 
• Wechsler Tests 
• Child Behavior Checklist (CBCL)/Adult Behavior Checklist (ABCL) 
• Social Communication Questionnaire (SCQ) 
• Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) 
4.4 
End of Treatment/Withdrawal Visit 
This visit will occur: 1) following early withdrawal from the trial; 2) in place of the next 
scheduled clinic visit (assessment or resupply) when GWP42003-P is approved in TSC 
and is commercially available to the patient; or 3) after a maximum of 4 years of OLE 
treatment (i.e., 208 weeks [±7 days] from Visit B1); whichever occurs first. 
The following assessments will be made at the End of Treatment/Withdrawal visit: 
• Vital signs 
• Physical examination (including height and body weight) 
• Details of menstruation (for females) 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
Confidential 
Page 11 of 17 
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V1, 24Sep15 
• Tanner staging (patients aged 10–17 [inclusive] only) 
• ECG 
• IVRS and paper diary information (including information regarding seizures, 
AEs, usage of rescue medication, concomitant AEDs, and IMP dosing) 
• Epilepsy-related hospitalizations 
• Concomitant medications and/or changes to medication 
• AEs 
• QOLCE/QOLIE-31-P 
• SGIC/CGIC 
• PGIC 
• SGIC-SD/CGIC-SD 
• Wechsler Tests 
• CBCL/ABCL 
• SCQ 
• Vineland-II 
• Suicidality, assessed in accordance with Section 9.2.12.8 of the main protocol 
Clinical laboratory samples (blood and urine [where possible]), including a pregnancy 
test if appropriate (using both a serum sample and a urine dipstick), will be taken for 
hematology, biochemistry, urinalysis and determination of serum IGF-1 levels (for 
patients less than 18 years of age) to be performed by the central laboratory.  Provided 
that the risk/benefit outcome is favorable in the investigator’s opinion, a blood sample 
will be taken for analysis of plasma concentrations of concomitant AEDs.  The 
investigator must assess adherence to the dosing regimen. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made.  For patients who withdraw early, the IVRS will be contacted to 
confirm withdrawal from the trial.  For patients who immediately continue to use 
commercial GWP42003-P following the End of Treatment visit, the IVRS will be 
contacted to confirm the patient’s completion of this trial and the paper diaries will be 
collected.  For patients 12 years of age and older who complete treatment and 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
Confidential 
Page 12 of 17 
Clinical Protocol Annex Template 
V1, 24Sep15 
immediately continue to use commercial GWP42003-P, or for patients 12 years of age 
and older who withdraw early and do not taper IMP, the trained investigator or study 
coordinator will complete the Study Medication Use and Behavior Survey as an interview 
with the patient/caregiver. 
For patients who complete treatment but do not immediately continue to use commercial 
GWP42003-P following the End of Treatment visit, IMP will be tapered at home (10% 
per day for 10 days).  Additional IMP will be dispensed, if required, and instructions for 
tapering the dose will be provided.  Patients who withdraw early should also begin the 
taper period following the Withdrawal visit unless continued dosing is not possible due to 
an AE.  Information will continue to be recorded in the paper diary during the taper 
period. 
Following the End of Treatment/Withdrawal visit, the IVRS seizure reporting diary 
should be completed up to the Follow-up visit. 
4.5 
End of Taper Visit 
This visit is required for patients who: 1) withdraw from the trial and taper IMP; or 
2) complete treatment but do not immediately continue to use commercial GWP42003-P.  
The End of Taper visit will take place 10 (+3) days after the End of 
Treatment/Withdrawal visit.  For patients who begin to taper IMP but subsequently 
withdraw/do not complete the full taper period, this visit should occur on the final day of 
dosing or as soon as possible after this date. 
The following assessments will be made: 
• Vital signs 
• Physical examination (including height and body weight) 
• IVRS and paper diary information (including information regarding seizures, 
AEs, usage of rescue medication, concomitant AEDs, and IMP dosing) 
• Epilepsy-related hospitalizations 
• Concomitant medications and/or changes to medication 
• AEs 
• Suicidality, assessed in accordance with Section 9.2.12.8 of the main protocol 
• ECG 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
Confidential 
Page 13 of 17 
Clinical Protocol Annex Template 
V1, 24Sep15 
• Clinical laboratory samples (blood and urine for hematology, biochemistry and 
urinalysis) 
The investigator must assess adherence to the dosing regimen. 
For patients 12 years of age and older, the trained investigator or study coordinator will 
complete the Study Medication Use and Behavior Survey as an interview with the 
patient/caregiver. 
All IMP (used and unused) will be collected and a check of the returned IMP against 
usage should be made. 
Following the End of Taper visit (or date of final dosing), the IVRS seizure reporting 
diary should be completed up to the Follow-up visit. 
4.6 
Safety Telephone Call 
This visit is required for patients who withdraw from the trial or complete treatment but 
do not immediately continue to use commercial GWP42003-P.  The Safety Telephone 
Call will be conducted 2 weeks (+3 days) after the patient’s last dose of GWP42003-P 
(including final taper period dose).  During this call, caregivers will be asked for 
information on: 
• AEs 
• Epilepsy-related hospitalizations 
• Concomitant medications and/or changes to medication 
Following this call, the IVRS seizure reporting diary should be completed up to the 
Follow-up visit. 
4.7 
Follow-up Visit 
This visit is required for patients who withdraw from the trial or complete treatment but 
do not immediately continue to use commercial GWP42003-P.  The Follow-up visit will 
take place 4 weeks (+3 days) after the patient’s last dose of GWP42003-P (including final 
taper period dose) and can be conducted by telephone.  During this visit/call, caregivers 
will be asked for information on: 
• AEs 
• Epilepsy-related hospitalizations 
• Concomitant medications and/or changes to medication 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
Confidential 
Page 14 of 17 
Clinical Protocol Annex Template 
V1, 24Sep15 
5 
INFORMED CONSENT/ASSENT 
An institutional review board/independent ethics committee-approved informed 
consent/assent form will be given to eligible patients prior to Visit B10 of the parent trial 
(please refer to Section 9.1.2.11 of the main trial protocol) which will reflect the 
additional implications of this annex. 
6 
DATA ANALYSIS 
6.1 
Patients to Analyze 
Patients in the US who continue to participate in years 2, 3, and 4 of the OLE will be 
analyzed in accordance with the statistical considerations detailed in Section 13 of the 
main protocol. 
7 
IMPLEMENTATION OF THE ANNEX 
This clinical protocol annex will be issued in conjunction with the current version of the 
main clinical trial protocol.  It will be kept in the trial master file at GW as well as in each 
US investigational center file and, if applicable, pharmacy site file.


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
Confidential 
Page 15 of 17 
Clinical Protocol Annex Template 
V1, 24Sep15 
APPENDIX 1 
SCHEDULE OF ASSESSMENTS 
Open-label Extension 
Visit Number 
B10 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
End of 
Treatment/ 
Withdrawal 
Visit 
End of 
Taper Visitb 
Safety 
Telephone 
Callb, c 
Follow-up 
Visitb, d 
B13 B14 
B15 
B16 B17 
B18 
B19 B20 
B21 
B22 B23 
B24 
B25 B26 
B27 
B28 B29 
Week 
52 
61 
70 
78 
87 
96 
104 
113 122 
130 
139 148 
156 
165 174 
182 
191 200 
See 
footnotea 
10 days after 
End of 
Treatment 
2 weeks 
after last 
dose 
4 weeks 
after last 
dose 
Visit Window 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
+3 
+3 
+3 
Informed consent/assent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vital signs and BP 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Physical examination 
(including height and body 
weight) 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
ECG 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Clinical laboratory blood 
sampling  
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Clinical laboratory urine 
sampling (dipstick 
urinalysis)  
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Pregnancy test, where 
appropriate 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
IGF-1 testing 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
AED concentration 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
AEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Inpatient epilepsy-related 
hospitalizations 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Suicidality assessment 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
Confidential 
Page 16 of 17 
Clinical Protocol Annex Template 
V1, 24Sep15 
Visit Number 
B10 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
End of 
Treatment/ 
Withdrawal 
Visit 
End of 
Taper Visitb 
Safety 
Telephone 
Callb, c 
Follow-up 
Visitb, d 
B13 B14 
B15 
B16 B17 
B18 
B19 B20 
B21 
B22 B23 
B24 
B25 B26 
B27 
B28 B29 
Week 
52 
61 
70 
78 
87 
96 
104 
113 122 
130 
139 148 
156 
165 174 
182 
191 200 
See 
footnotea 
10 days after 
End of 
Treatment 
2 weeks 
after last 
dose 
4 weeks 
after last 
dose 
Visit Window 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
+3 
+3 
+3 
Vineland-II 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
SGIC/CGIC 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
PGIC 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
SGIC-SD/CGIC-SD 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
QOLCE/QOLIE-31-P 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Wechsler Tests  
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
CBCL/ABCL 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
SCQ 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Tanner Staging (where 
appropriate) 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Menstruation question 
(where appropriate) 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Patient IVRS and paper diary 
review (seizures, AE 
information, concomitant 
AEDs, rescue medication, 
IMP dosing) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
IMP dispensing 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Collection of IMP 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
IMP compliance review 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Study Medication Use and 
Behavior Survey 
 
 
 
 
 
 
 
 
 
 
 
 
Xe 
 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 V3 15Apr19 
 
Confidential 
Page 17 of 17 
Clinical Protocol Annex Template 
V1, 24Sep15 
a End of Treatment/Withdrawal Visit will occur: 1) following early withdrawal from the trial; 2) in place of the next scheduled clinic visit (assessment or 
resupply) when GWP42003-P is approved in TSC and is commercially available to the patient; or 3) after a maximum of 4 years of OLE treatment 
(i.e., 208 weeks [±7 days] from Visit B1); whichever occurs first. 
b Only required for patients who withdraw from the trial or complete treatment but do not immediately continue to use commercial GWP42003-P. 
c Safety Telephone Call must be made 2 weeks (+3 days) after the patient’s last dose of IMP. 
d Follow-up Visit required for patients who withdraw from the trial or complete treatment but do not immediately continue to use commercial GWP42003-P.  
This must be made 4 weeks (+3 days) after the patient’s last dose of IMP and can be conducted by telephone. 
e Performed at final dosing visit (End of Treatment/Withdrawal visit or End of Taper visit, as applicable) for patients 12 years of age and older only. 


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Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 2 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
1 
PROTOCOL SYNOPSIS 
Trial Title 
A double-blind, randomized, placebo-controlled study to 
investigate the efficacy and safety of cannabidiol (GWP42003-P, 
CBD) as add-on therapy in patients with tuberous sclerosis 
complex who experience inadequately-controlled seizures. 
Indication 
Seizuresa in patients with tuberous sclerosis complex (TSC). 
Trial Design 
Trial GWEP1521 consists of a randomized, parallel-group, 
16-week double-blind phase comparing 2 doses of GWP42003-P 
with placebo, followed by a 1-year open-label extension (OLE) 
phase.  Clinical Protocol Annex 1 (US Only) Version 3 extends 
the OLE phase by a further 3 years in the United States. 
Patients will complete the OLE phase when GWP42003-P is 
approved in TSC and is commercially available to the patient, or 
after a maximum of 4 years of OLE treatment, whichever occurs 
first. 
Sponsor 
GW Research Ltd 
Sovereign House 
Vision Park 
Chivers Way 
Histon 
Cambridge CB24 9BZ 
United Kingdom 
 
                                                 
a 
Seizures include: focal motor seizures without impairment of consciousness or 
awareness; focal seizures with impairment of consciousness or awareness; focal seizures 
evolving to bilateral generalized convulsive seizures, and generalized seizures (tonic–clonic, 
tonic, clonic, or atonic) that are countable. 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 3 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Table of Contents 
Title Page .................................................................................................. 1 
1 
PROTOCOL SYNOPSIS ............................................................... 2 
Table of Contents ..................................................................................... 3 
List of Appendices.................................................................................... 4 
2 
RATIONALE .................................................................................. 5 
2.1    DURATION OF OPEN-LABEL EXTENSION PHASE ............ 5 
3 
IMPLEMENTATION OF THE AMENDMENT ........................ 6 
4 
PRESENTATION OF AMENDED TEXT .................................. 7 
5 
REFERENCES ............................................................................. 14 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 4 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
List of Appendices 
APPENDIX 1 
AMENDED FIGURES AND TABLES ............................... 15 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 5 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
2 
RATIONALE 
This Clinical Protocol Annex 1 (US only) amendment 2 (will be incorporated into the 
Protocol Annex creating Clinical Protocol Annex 1 [US only] Version 3, Date 
15 April 2019) addresses the following issue(s): 
2.1 
Duration of Open-label Extension Phase 
The OLE phase will be extended in duration in the US to ensure continued access to 
GWP42003-P prior to approval.  Patients will complete the OLE phase when 
GWP42003-P is approved in TSC and is commercially available to the patient, or 
after a maximum of 4 years of OLE treatment, whichever occurs first.  Procedures for 
each resupply visit and assessment visit have been condensed into single sections in 
the Annex to minimize repetition. 
 
 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 6 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
3 
IMPLEMENTATION OF THE AMENDMENT 
The changes detailed in this amendment will be issued as Clinical Protocol Annex 1 
(US Only) Version 3, Date 15 April 2019.  It will be kept in the trial master file at 
GW as well as in each investigational centre file and, if applicable, pharmacy site file. 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 7 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
4 
PRESENTATION OF AMENDED TEXT 
The text will be amended as follows: 
Revised Protocol 
Annex Section 
Number, Heading 
and Page Number 
Original Wording from Clinical Protocol Annex 1 
(US Only) Version 2, Date 26 April 2018 
(Deleted wording is struck through and in bold) 
Revised Wording from Clinical Protocol Annex 1 
(US Only) Amendment 2 
Clinical Protocol Annex 1 (US Only) Version 3, 
Date 15 April 2019 
(Revised wording is underscored and in bold) 
Rationale for the 
amendment 
Title page 
p. 1 
(...) 
This annex outlines the assessments and procedures for 
years 2 and 3 of the open-label extension. 
(...) 
(...) 
This annex outlines the assessments and procedures for 
years 2–4 of the open-label extension. 
(...) 
See Section 2.1 
Section 1 
RATIONALE 
p. 6 
 
 
 
 
 
 
 
(...) 
To ensure continued access to GWP42003-P prior to 
approval, the OLE phase will be extended to a total of 
3 years in duration in the United States (US).   
(...) 
Patients will complete the OLE phase when 
GWP42003-P is approved in tuberous sclerosis complex 
(TSC) and is commercially available to the patient, or 
after a maximum of 3 years’ OLE treatment, whichever 
occurs first.  The intent is to ensure continued access 
(...) 
To ensure continued access to GWP42003-P prior to 
approval, the OLE phase will be extended to a total of 
4 years in duration in the United States (US).   
(...) 
Patients will complete the OLE phase when 
GWP42003-P is approved in tuberous sclerosis complex 
(TSC) and is commercially available to the patient, or 
after a maximum of 4 years of OLE treatment, 
whichever occurs first.   
See Section 2.1 
 
 
 
 
 
 
 
 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 8 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Revised Protocol 
Annex Section 
Number, Heading 
and Page Number 
Original Wording from Clinical Protocol Annex 1 
(US Only) Version 2, Date 26 April 2018 
(Deleted wording is struck through and in bold) 
Revised Wording from Clinical Protocol Annex 1 
(US Only) Amendment 2 
Clinical Protocol Annex 1 (US Only) Version 3, 
Date 15 April 2019 
(Revised wording is underscored and in bold) 
Rationale for the 
amendment 
 
Section 1 
RATIONALE 
p. 6 (continued) 
 
to GWP42003-P through compassionate schemes 
(e.g., Named Patient Supply) in other countries.  
However, in countries where compassionate access 
proves difficult prior to first approvals, the OLE 
duration may also be extended to include these 
additional countries. 
 
See Section 2.1 
Section 2 
SUMMARY OF 
THE ANNEX 
p. 6 
 
 
 
 
 
 
 
 
(...) 
 
Dosing will remain consistent and there is no 
requirement for dose adjustment or further titration upon 
entry into years 2 or 3. 
 
Assessment visits have been added at Week 78, 
Week 104, Week 130, and Week 156 (relative to 
Visit B1).  Investigational medicinal product (IMP) 
dispensing visits have also been added between 
assessment visits in years 2 and 3 to ensure resupply 
(...) 
Patients who complete OLE year 3 may enter a 
fourth year of OLE treatment.  Dosing will remain 
consistent and there is no requirement for dose 
adjustment or further titration upon entry into years 2, 3, 
or 4. 
Assessment visits have been added at Week 78, 
Week 104, Week 130, Week 156, and Week 182 
(relative to Visit B1).  Investigational medicinal product 
(IMP) dispensing visits have also been added between 
assessment visits in years 2, 3, and 4 to ensure resupply 
See Section 2.1 
 
 
 
 
 
 
 
 
 
 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 9 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Revised Protocol 
Annex Section 
Number, Heading 
and Page Number 
Original Wording from Clinical Protocol Annex 1 
(US Only) Version 2, Date 26 April 2018 
(Deleted wording is struck through and in bold) 
Revised Wording from Clinical Protocol Annex 1 
(US Only) Amendment 2 
Clinical Protocol Annex 1 (US Only) Version 3, 
Date 15 April 2019 
(Revised wording is underscored and in bold) 
Rationale for the 
amendment 
 
 
Section 2 
SUMMARY OF 
THE ANNEX 
p. 6 (continued) 
 
 
 
 
 
volumes are manageable for both patients and dispensing 
staff.   
(...) 
Patients will complete the OLE phase when 
GWP42003-P is approved in TSC and is commercially 
available to the patient, or after a maximum of 3 years’ 
OLE treatment, whichever occurs first.   
(...) 
A safety follow-up visit will be completed 4 weeks after 
the End of Taper visit. 
volumes are manageable for both patients and dispensing 
staff.   
(...) 
Patients will complete the OLE phase when 
GWP42003-P is approved in TSC and is commercially 
available to the patient, or after a maximum of 4 years of 
OLE treatment, whichever occurs first.   
(...) 
A safety follow-up telephone call will be 
completed 2 weeks after the End of Taper visit 
and a safety Follow-up visit will be completed 
4 weeks after the End of Taper visit. 
 
 
See Section 2.1 
 
Section 4 
DESIGN AND 
PROCEDURES 
p. 8 
Patients and their parent(s)/legal representative will be 
invited to participate in years 2 and 3 of the OLE when 
they reach Visit B10 of the OLE phase.   
(...) 
Patients and their parent(s)/legal representative will be 
invited to participate in years 2, 3, and 4 of the OLE 
when they reach Visit B10 of the OLE phase.   
(...) 
See Section 2.1 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 10 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Revised Protocol 
Annex Section 
Number, Heading 
and Page Number 
Original Wording from Clinical Protocol Annex 1 
(US Only) Version 2, Date 26 April 2018 
(Deleted wording is struck through and in bold) 
Revised Wording from Clinical Protocol Annex 1 
(US Only) Amendment 2 
Clinical Protocol Annex 1 (US Only) Version 3, 
Date 15 April 2019 
(Revised wording is underscored and in bold) 
Rationale for the 
amendment 
Patients will continue to make weekly interactive voice 
response system (IVRS) diary calls throughout their 
second and third years of OLE participation. 
Patients will continue to make weekly interactive voice 
response system (IVRS) diary calls throughout their 
second, third, and fourth years of OLE participation. 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 11 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Revised Protocol 
Annex Section 
Number, Heading 
and Page Number 
Original Wording from Clinical Protocol Annex 1 
(US Only) Version 2, Date 26 April 2018 
(Deleted wording is struck through and in bold) 
Revised Wording from Clinical Protocol Annex 1 
(US Only) Amendment 2 
Clinical Protocol Annex 1 (US Only) Version 3, 
Date 15 April 2019 
(Revised wording is underscored and in bold) 
Rationale for the 
amendment 
Section 4.2 
Resupply Visits 
B13 (Week 61), 
B14 (Week 70), 
B16 (Week 87), 
B17 (Week 96), 
B19 (Week 113), 
B20 (Week 122), 
B22 (Week 139), 
and B23 (Week 
148), B25 (Week 
165), B26 (Week 
174), B28 (Week 
191), and B29 
(Week 200) 
p. 8 
4.2 
Resupply Visits B13 (Week 61), B14 (Week 70), 
B16 (Week 87), B17 (Week 96), B19 (Week 113), 
B20 (Week 122), B22 (Week 139), and 
B23 (Week 148) 
Visits B13, B14, B16, B17, B19, B20, B22, and B23 
will occur 61, 70, 87, 96, 113, 122, 139, and 148 weeks 
after Visit B1, respectively. 
 
 
 
(…) 
4.2 
Resupply Visits B13 (Week 61), B14 (Week 70), 
B16 (Week 87), B17 (Week 96), B19 (Week 113), 
B20 (Week 122), B22 (Week 139), 
B23 (Week 148), B25 (Week 165), 
B26 (Week 174), B28 (Week 191), and 
B29 (Week 200) 
Visits B13, B14, B16, B17, B19, B20, B22, and B23, 
B25, B26, B28, and B29 will occur 61, 70, 87, 96, 113, 
122, 139, 148, 165, 174, 191, and 200 weeks after 
Visit B1, respectively. 
(…) 
See Section 2.1 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 12 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Revised Protocol 
Annex Section 
Number, Heading 
and Page Number 
Original Wording from Clinical Protocol Annex 1 
(US Only) Version 2, Date 26 April 2018 
(Deleted wording is struck through and in bold) 
Revised Wording from Clinical Protocol Annex 1 
(US Only) Amendment 2 
Clinical Protocol Annex 1 (US Only) Version 3, 
Date 15 April 2019 
(Revised wording is underscored and in bold) 
Rationale for the 
amendment 
Section 4.3 
Assessment Visits 
B15 (Week 78), 
B18 (Week 104), 
and B21 (Week 
130), B24 (Week 
156), and B27 
(Week 182) 
p. 9 
4.3 
Assessment Visits B15 (Week 78), B18 
(Week 104), and B21 (Week 130) 
Visits B15, B18, and B21 will occur 78, 104, and 
130 weeks after Visit B1, respectively.   
 
 
(...) 
In addition to the above, the following assessments will 
be made at Visit B18 only: 
(...) 
4.3 
Assessment Visits B15 (Week 78), B18 (Week 
104), B21 (Week 130), B24 (Week 156), and 
B27 (Week 182) 
Visits B15, B18, and B21, B24, and B27 will occur 78, 
104, 130, 156, and 182 weeks after Visit B1, 
respectively.   
(...) 
In addition to the above, the following assessments will 
be made at Visit B18 and Visit B24: 
(...) 
See Section 2.1 
Section 4.4 
End of Treatment/ 
Withdrawal Visit 
p.10 
This visit will occur: 1) following early withdrawal from 
the trial; 2) in place of the next scheduled clinic visit 
(assessment or resupply) when GWP42003-P is 
approved in TSC and is commercially available to the 
patient; or 3) after a maximum of 3 years’ OLE 
treatment (i.e., 156 weeks [±7 days] from Visit B1); 
whichever occurs first. 
(...) 
This visit will occur: 1) following early withdrawal from 
the trial; 2) in place of the next scheduled clinic visit 
(assessment or resupply) when GWP42003-P is 
approved in TSC and is commercially available to the 
patient; or 3) after a maximum of 4 years of OLE 
treatment (i.e., 208 weeks [±7 days] from Visit B1); 
whichever occurs first. 
(...) 
See Section 2.1 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 13 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Revised Protocol 
Annex Section 
Number, Heading 
and Page Number 
Original Wording from Clinical Protocol Annex 1 
(US Only) Version 2, Date 26 April 2018 
(Deleted wording is struck through and in bold) 
Revised Wording from Clinical Protocol Annex 1 
(US Only) Amendment 2 
Clinical Protocol Annex 1 (US Only) Version 3, 
Date 15 April 2019 
(Revised wording is underscored and in bold) 
Rationale for the 
amendment 
Section 6.1 
Patients to Analyze 
p. 14 
Patients in the US who continue to participate in years 2 
and 3 of the OLE will be analyzed in accordance with 
the statistical considerations detailed in Section 13 of the 
main protocol. 
Patients in the US who continue to participate in years 2,  
3, and 4 of the OLE will be analyzed in accordance with 
the statistical considerations detailed in Section 13 of the 
main protocol. 
See Section 2.1 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 14 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
5 
REFERENCES 
N/A 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 15 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
 APPENDIX 1 
AMENDED FIGURES AND TABLES 
Original Figure from Clinical Protocol Annex 1 (US Only) Version 2, Date 26 April 2018 
(Deleted wording is struck through and in bold) 
3 
TREATMENT SCHEMATIC DIAGRAM 
ASSESSMENT
Visit B10
Week 52
(±7 days)
ASSESSMENT
Visit B15
Week 78
(±7 days)
 B13e
Week 
61
 B14e
Week 
70
ASSESSMENT
Visit B18
Week 104
(±7 days)
 B16e
Week 
87
 B17e
Week 
96
ASSESSMENT
Visit B21
Week 130
(±7 days)
 B19e
Week 
113
 B20e
Week 
122
END OF TREATMENT
 B22e
Week 
139
 B23e
Week 
148
26 weeks
26 weeks
26 weeks
26 weeks
END OF TAPER
End of 
Taper 
Visitb
(+3 days)
10 days
Taper 
Period
SAFETY CALL
Safety 
Telephone 
Callb, c
(+3 days)
FOLLOW-UP VISIT
Follow-up 
Visitb, d
(+3 days)
2 weeks
4 weeks
Safety Follow-up Period
OLE YEAR 1
OLE Year 2
OLE Year 3
End of 
Treatment/
Withdrawal 
Visita
 
a End of Treatment/Withdrawal Visit will occur: 1) following early withdrawal from the trial; 2) in place of the next scheduled clinic visit (assessment or resupply) when 
GWP42003-P is approved in TSC and is commercially available to the patient; or 3) after a maximum of 3 years’ OLE treatment (i.e., 156 weeks [±7 days] from 
Visit B1); whichever occurs first. 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 16 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
b Only required for patients who withdraw from the trial or complete treatment but do not immediately continue to use commercial GWP42003-P. 
c Safety Telephone Call must be made 2 weeks (+3 days) after the patient’s last dose of IMP. 
d This must be made 4 weeks (+3 days) after the patient’s last dose of IMP and can be conducted by telephone. 
e Visits B13, B14, B16, B17, B19, B20, B22, B23 – Resupply visits (±7 days). 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 17 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Revised Figure from Clinical Protocol Annex 1 (US Only) Amendment 2 
Clinical Protocol Annex 1 (US Only) Version 3, Date 15 April 2019 
(Additional text is underscored and in bold; new lines are blue) 
 
a End of Treatment/Withdrawal Visit will occur: 1) following early withdrawal from the trial; 2) in place of the next scheduled clinic visit (assessment or resupply) when 
GWP42003-P is approved in TSC and is commercially available to the patient; or 3) after a maximum of 4 years of OLE treatment (i.e., 208 weeks [±7 days] from 
Visit B1); whichever occurs first. 
b Only required for patients who withdraw from the trial or complete treatment but do not immediately continue to use commercial GWP42003-P. 
c Safety Telephone Call must be made 2 weeks (+3 days) after the patient’s last dose of IMP. 
d This must be made 4 weeks (+3 days) after the patient’s last dose of IMP and can be conducted by telephone. 
e Visits B13, B14, B16, B17, B19, B20, B22, B23, B25, B26, B28, and B29 – Resupply visits (±7 days). 
 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 18 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Original Table from Clinical Protocol Annex 1 (US Only) Version 2, Date 26 April 2018 
 
APPENDIX 1 
SCHEDULE OF ASSESSMENTS 
Open-label Extension 
Visit Number 
B10 
Re-
supply 
Assess-
ment 
Re-
supply 
Assess-
ment 
Re-
supply 
Assess-
ment 
Re-
supply 
End of 
Treatment/ 
Withdrawal 
Visit 
End of Taper 
Visitb 
Safety 
Telephone 
Callb, c 
Follow-up 
Visitb, d 
B13 B14 
B15 
B16 B17 
B18 
B19 B20 
B21 
B22 B23 
Week 
52 
61 
70 
78 
87 
96 
104 
113 122 
130 
139 148 
See 
footnotea 
10 days after 
End of 
Treatment 
2 weeks 
after last 
dose 
4 weeks 
after last 
dose 
Visit Window 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
+3 
+3 
+3 
Informed consent/assent 
X 
 
 
 
 
 
 
 
 
 
 
 
Vital signs and BP 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Physical examination 
(including height and body 
weight) 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
ECG 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Clinical laboratory blood 
sampling  
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Clinical laboratory urine 
sampling (dipstick urinalysis)  
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Pregnancy test, where 
appropriate 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
IGF-1 testing 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
AED concentration 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
AEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 19 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Visit Number 
B10 
Re-
supply 
Assess-
ment 
Re-
supply 
Assess-
ment 
Re-
supply 
Assess-
ment 
Re-
supply 
End of 
Treatment/ 
Withdrawal 
Visit 
End of Taper 
Visitb 
Safety 
Telephone 
Callb, c 
Follow-up 
Visitb, d 
B13 B14 
B15 
B16 B17 
B18 
B19 B20 
B21 
B22 B23 
Week 
52 
61 
70 
78 
87 
96 
104 
113 122 
130 
139 148 
See 
footnotea 
10 days after 
End of 
Treatment 
2 weeks 
after last 
dose 
4 weeks 
after last 
dose 
Visit Window 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
+3 
+3 
+3 
Concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Inpatient epilepsy-related 
hospitalizations 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Suicidality assessment 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Vineland-II 
X 
 
 
 
X 
 
 
 
X 
 
 
 
SGIC/CGIC 
X 
 
 
 
X 
 
 
 
X 
 
 
 
PGIC 
X 
 
 
 
X 
 
 
 
X 
 
 
 
SGIC-SD/CGIC-SD 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
QOLCE/QOLIE-31-P 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Wechsler Tests  
X 
 
 
 
X 
 
 
 
X 
 
 
 
CBCL/ABCL 
X 
 
 
 
X 
 
 
 
X 
 
 
 
SCQ 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Tanner Staging (where 
appropriate) 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Menstruation question (where 
appropriate) 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Patient IVRS and paper diary 
review (seizures, AE 
information, concomitant 
AEDs, rescue medication, IMP 
dosing) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
IMP dispensing 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Collection of IMP 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 20 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Visit Number 
B10 
Re-
supply 
Assess-
ment 
Re-
supply 
Assess-
ment 
Re-
supply 
Assess-
ment 
Re-
supply 
End of 
Treatment/ 
Withdrawal 
Visit 
End of Taper 
Visitb 
Safety 
Telephone 
Callb, c 
Follow-up 
Visitb, d 
B13 B14 
B15 
B16 B17 
B18 
B19 B20 
B21 
B22 B23 
Week 
52 
61 
70 
78 
87 
96 
104 
113 122 
130 
139 148 
See 
footnotea 
10 days after 
End of 
Treatment 
2 weeks 
after last 
dose 
4 weeks 
after last 
dose 
Visit Window 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
+3 
+3 
+3 
IMP compliance review 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Study Medication Use and 
Behavior Survey 
 
 
 
 
 
 
 
 
Xe 
 
 
a End of Treatment/Withdrawal Visit will occur: 1) following early withdrawal from the trial; 2) in place of the next scheduled clinic visit (assessment or resupply) when 
GWP42003-P is approved in TSC and is commercially available to the patient; or 3) after a maximum of 3 years’ OLE treatment (i.e., 156 weeks [±7 days] from 
Visit B1); whichever occurs first. 
b Only required for patients who withdraw from the trial or complete treatment but do not immediately continue to use commercial GWP42003-P. 
c Safety Telephone Call must be made 2 weeks (+3 days) after the patient’s last dose of IMP. 
d Follow-up Visit required for patients who withdraw from the trial or complete treatment but do not immediately continue to use commercial GWP42003-P.  This must 
be made 4 weeks (+3 days) after the patient’s last dose of IMP and can be conducted by telephone. 
e Performed at final dosing visit (End of Treatment/Withdrawal visit or End of Taper visit, as applicable) for patients 12 years of age and older only 
 
 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 21 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Revised Table from Clinical Protocol Annex 1 (US Only) Amendment 2 
Clinical Protocol Annex 1 (US Only) Version 3, Date 15 April 2019 
(Additional text is underscored and in bold; new lines are blue) 
Open-label Extension 
Visit Number 
B10 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
End of 
Treatment/ 
Withdrawal 
Visit 
End of 
Taper Visitb 
Safety 
Telephone 
Callb, c 
Follow-up 
Visitb, d 
B13 
B14 
B15 
B16 
B17 
B18 
B19 
B20 
B21 
B22 
B23 
B24 
B25 
B26 
B27 
B28 
B29 
Week 
52 
61 
70 
78 
87 
96 
104 
113 
122 
130 
139 
148 
156 
165 
174 
182 
191 
200 
See 
footnotea 
10 days 
after End of 
Treatment 
2 weeks 
after last 
dose 
4 weeks 
after last 
dose 
Visit Window 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
+3 
+3 
+3 
Informed 
consent/assent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vital signs and BP 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Physical 
examination 
(including height 
and body weight) 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
ECG 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Clinical 
laboratory blood 
sampling  
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Clinical 
laboratory urine 
sampling (dipstick 
urinalysis)  
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Pregnancy test, 
where appropriate 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
IGF-1 testing 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 22 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Visit Number 
B10 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
End of 
Treatment/ 
Withdrawal 
Visit 
End of 
Taper Visitb 
Safety 
Telephone 
Callb, c 
Follow-up 
Visitb, d 
B13 
B14 
B15 
B16 
B17 
B18 
B19 
B20 
B21 
B22 
B23 
B24 
B25 
B26 
B27 
B28 
B29 
Week 
52 
61 
70 
78 
87 
96 
104 
113 
122 
130 
139 
148 
156 
165 
174 
182 
191 
200 
See 
footnotea 
10 days 
after End of 
Treatment 
2 weeks 
after last 
dose 
4 weeks 
after last 
dose 
Visit Window 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
+3 
+3 
+3 
AED 
concentration 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
AEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant 
medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Inpatient epilepsy-
related 
hospitalizations 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Suicidality 
assessment 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Vineland-II 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
SGIC/CGIC 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
PGIC 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
SGIC-
SD/CGIC-SD 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
QOLCE/QOLIE-
31-P 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Wechsler Tests  
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
CBCL/ABCL 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
SCQ 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Tanner Staging 
(where 
appropriate) 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Menstruation 
question (where 
appropriate) 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 


Study Code: GWEP1521 
EudraCT Number: 2015-002154-12 
Protocol Annex 1 Amendment 2 V1 15Apr19 
 
 
Confidential 
Page 23 of 23 
Clinical Protocol Amendment Template 
V1, 24Sep15 
Visit Number 
B10 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
Assess-
ment 
Resupply 
End of 
Treatment/ 
Withdrawal 
Visit 
End of 
Taper Visitb 
Safety 
Telephone 
Callb, c 
Follow-up 
Visitb, d 
B13 
B14 
B15 
B16 
B17 
B18 
B19 
B20 
B21 
B22 
B23 
B24 
B25 
B26 
B27 
B28 
B29 
Week 
52 
61 
70 
78 
87 
96 
104 
113 
122 
130 
139 
148 
156 
165 
174 
182 
191 
200 
See 
footnotea 
10 days 
after End of 
Treatment 
2 weeks 
after last 
dose 
4 weeks 
after last 
dose 
Visit Window 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
±7 
+3 
+3 
+3 
Patient IVRS and 
paper diary review 
(seizures, AE 
information, 
concomitant 
AEDs, rescue 
medication, IMP 
dosing) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
IMP dispensing 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Collection of IMP 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
IMP compliance 
review 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Study Medication 
Use and Behavior 
Survey 
 
 
 
 
 
 
 
 
 
 
 
 
Xe 
 
 
a End of Treatment/Withdrawal Visit will occur: 1) following early withdrawal from the trial; 2) in place of the next scheduled clinic visit (assessment or resupply) when 
GWP42003-P is approved in TSC and is commercially available to the patient; or 3) after a maximum of 4 years of OLE treatment (i.e., 208 weeks [±7 days] from 
Visit B1); whichever occurs first. 
b Only required for patients who withdraw from the trial or complete treatment but do not immediately continue to use commercial GWP42003-P. 
c Safety Telephone Call must be made 2 weeks (+3 days) after the patient’s last dose of IMP. 
d Follow-up Visit required for patients who withdraw from the trial or complete treatment but do not immediately continue to use commercial GWP42003-P.  This must 
be made 4 weeks (+3 days) after the patient’s last dose of IMP and can be conducted by telephone. 
e Performed at final dosing visit (End of Treatment/Withdrawal visit or End of Taper visit, as applicable) for patients 12 years of age and older only. 


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SAP_001.pdf: 
Version: 23 Dec 19 
Confidential 
V2 21Sep17 
Clinical Study Report GWEP1521 
Appendix 1.9 Documentation of statistical methods 
GWEP1521 SAP Final V2 24Apr19 
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Trial Code: GWEP1521 
EudraCT Number: 2015-002154-12 
ClinicalTrials.gov Identifier: NCT02544763 
SAP Addendum, Date: 28th November 2019 
 
 
 
 
GWEP1521    
 
Page 1 of 8 
 
 
Confidential 
GW Research Ltd. 
Trial Code: GWEP1521 
 
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED 
STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF 
CANNABIDIOL (GWP42003-P, CBD) AS ADD-ON THERAPY IN 
PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX WHO 
EXPERIENCE INADEQUATELY-CONTROLLED SEIZURES 
 
Statistical Analysis Plan Addendum 
 
28th November 2019 
 
 
 
 
 


Trial Code: GWEP1521 
EudraCT Number: 2015-002154-12 
ClinicalTrials.gov Identifier: NCT02544763 
SAP Addendum, Date: 28th November 2019 
 
 
 
 
GWEP1521    
 
Page 2 of 8 
 
 
Confidential 
CONTENTS 
1. 
INTRODUCTION 
4 
2. 
STATISTICAL METHODS 
4 
2.1 
General Considerations 
4 
2.2 
Analysis Sets 
4 
2.3 
Efficacy Analysis 
4 
2.3.1 General Approach 
4 
2.3.2 Cumulative Distribution Function Plots of Percent Reduction in 
Seizure Frequency 
4 
2.3.3 Robustness to Withdrawn Patients 
4 
2.3.4 Onset of Efficacy 
5 
2.4 
Safety Evaluation 
6 
2.4.1 IMP Doses 
6 
3. 
AMENDMENTS 
6 
4. 
ATTACHMENTS AND APPENDICES 
7 


Trial Code: GWEP1521 
EudraCT Number: 2015-002154-12 
ClinicalTrials.gov Identifier: NCT02544763 
SAP Addendum, Date: 28th November 2019 
 
 
 
 
GWEP1521    
 
Page 3 of 8 
 
 
Confidential 
ABBREVIATIONS 
ITT 
- 
Intention to Treat 
NBR 
- 
Negative Binomial Regression 
SAP 
- 
Statistical Analysis Plan 


Trial Code: GWEP1521 
EudraCT Number: 2015-002154-12 
ClinicalTrials.gov Identifier: NCT02544763 
SAP Addendum, Date: 28th November 2019 
 
 
 
 
GWEP1521    
 
Page 4 of 8 
 
 
Confidential 
1. 
INTRODUCTION 
This document is an addendum to the statistical analysis plan (SAP) for trial GWEP1521, 
Version 2 dated 24th April 2019 (hereinafter referred to as the main SAP).  This addendum 
consists of descriptions for a number of post-hoc analyses to support a summary of clinical 
efficacy. 
2. 
STATISTICAL METHODS 
2.1 
General Considerations 
Unless otherwise stated, the statistical reporting definitions and considerations as stated in 
the main SAP will also apply to this addendum. 
All analyses and summaries will be produced using SAS® Version 9.4. 
2.2 
Analysis Sets 
The intention to treat (ITT) analysis set as defined in the main SAP will be the primary 
analysis set for all endpoints. 
2.3 
Efficacy Analysis 
2.3.1 
General Approach 
Statistical hypothesis testing will be performed as appropriate. However, no formal 
adjustment of statistical significance for multiple testing will be performed, although the 
multiplicity should be allowed for when interpreting the results.   
All statistical tests will be 2-sided and use the 5% significance level. 
2.3.2 
Cumulative Distribution Function Plots of Percent Reduction in Seizure 
Frequency 
Cumulative distribution plots plotting the percent reduction against the cumulative proportion 
of patients achieving that level of reduction, as described in the main SAP, will be generated 
for the following: 
x 
Patients taking clobazam. 
x 
Patients not taking clobazam. 
The above will be generated for TSC-associated seizures during the blinded phase 
treatment period. 
2.3.3 
Robustness to Withdrawn Patients 
There were higher proportions of patients in each treatment arm that withdrew during the 
blinded phase treatment period when compared with placebo. In order to assess the 
robustness of the results, 2 analyses in the following sections are proposed. 


Trial Code: GWEP1521 
EudraCT Number: 2015-002154-12 
ClinicalTrials.gov Identifier: NCT02544763 
SAP Addendum, Date: 28th November 2019 
 
 
 
 
GWEP1521    
 
Page 5 of 8 
 
 
Confidential 
2.3.3.1 Time to 10th and 20th Seizure 
Time from Day 1 to a patient experiencing their 10th and 20th or more seizure will be 
calculated as follows: 
Date criterion was achieved – Date of Day 1 – Number of unreported days in IVRS between 
Day 1 and date criterion was achieved + 1 
Patients who complete the blinded phase without experiencing greater than or equal to the 
corresponding number of seizures, or who withdraw from the blinded phase, will be 
censored at the earliest of: 
x 
Day 113. 
x 
The last recorded seizure day during the blinded phase treatment period. 
The exact day used for censoring will be the day obtained from above minus the number of 
unreported days in IVRS between Day 1 and the day obtained from above. 
The advantage of this proposed time to event analysis is that it is distinctly less sensitive to 
early withdrawals. 
The time to corresponding event will be summarized on a continuous scale, by treatment 
arm. The lower and upper quartiles will also be presented along with the number of events 
and number of patients censored.  In addition, the hazard ratio and 95% confidence interval, 
from a Cox proportional hazards model including treatment arm and stratified age group as 
covariates, will be presented along with a p-value from a log-rank test.  A corresponding 
Kaplan-Meier plot will also be produced for both TSC-associated seizures and total 
seizures. 
2.3.3.2 Analysis using Worst Case of No Change or Observed Worsening 
The negative binomial regression (NBR) primary analysis will be repeated penalizing 
patients in the 25 mg/kg/day or 50 mg/kg/day treatment arms who withdrew during the 
blinded phase treatment period.  The following will be used as the analysis value for 
withdrawn patients in the active arms: 
x 
Patients with a reduction (improvement) in percentage change from baseline during 
the blinded phase treatment period will be imputed by setting the treatment period 
denominator, used in the NBR offset, to 113 days and the seizure count set to a 
value giving the same daily average observed during the baseline period. 
x 
Patients with an increase (worsening) in percentage change from baseline during 
the blinded phase treatment period will be imputed by setting the treatment period 
denominator, used in the NBR offset, to 113 days and the seizure count set to a 
value giving the same daily average observed during the treatment period. 
The primary endpoint analysis will be repeated using the above imputation. 
2.3.4 
Onset of Efficacy 
To estimate the time to onset of efficacy, the NBR primary analysis and the first key 
secondary endpoint of 50% reduction in seizure frequency will be repeated by each 
cumulative day (e.g. Day 1, Day 1 and 2, Day 1, 2 and 3, etc.) of the blinded phase 
treatment period for TSC-associated seizures.  In addition, the 25 mg/kg/day and 50 
mg/kg/day treatment arms will be pooled and the above repeated for the first 10 days only. 


Trial Code: GWEP1521 
EudraCT Number: 2015-002154-12 
ClinicalTrials.gov Identifier: NCT02544763 
SAP Addendum, Date: 28th November 2019 
 
 
 
 
GWEP1521    
 
Page 6 of 8 
 
 
Confidential 
2.4 
Safety Evaluation 
2.4.1 
IMP Doses 
For patients randomized to the 25 mg/kg/day or 50 mg/kg/day treatment arms, the following 
will be calculated for the blinded phase treatment period: 
x 
Maximum dose achieved. 
x 
Dose at the end of the period or time of withdrawal. 
x 
Modal dose. 
Unless missed doses or a dose reduction is recorded during the titration period, it will be 
assumed that patients were titrated according to the titration schedule stated in the protocol. 
The blinded phase treatment period will be defined as Day 1 to earliest of the day of last 
blinded phase dose or Day 113.The following will be summarized for patients randomized to 
the 25 mg/kg/day or 50 mg/kg/day treatment arms: 
x 
Proportion of patients achieving the target maintenance dose. 
x 
Proportion of patients at the target maintenance dose at the end of the blinded 
phase treatment period or time of withdrawal. 
x 
Maximum dose achieved (mg/kg/day). 
x 
Dose at the end of the blinded phase treatment period or time of withdrawal 
(mg/kg/day). 
x 
Modal dose during the blinded phase treatment period (mg/kg/day). 
3. 
AMENDMENTS 
Notable changes to the SAP addendum between approved versions are given below.  Minor 
changes, clarifications and corrections are not listed. 
Date 
Section 
Description of Change 
None 
 
 
 
 
 
 
 
 
 
 
 


Trial Code: GWEP1521 
EudraCT Number: 2015-002154-12 
ClinicalTrials.gov Identifier: NCT02544763 
SAP Addendum, Date: 28th November 2019 
 
 
 
 
GWEP1521    
 
Page 7 of 8 
 
 
Confidential 
4. 
ATTACHMENTS AND APPENDICES 
Appendix 1 
List of Tables and Figures 
Lists of the tables, figures and listings to be provided are given below in Table 1 Table 2 
and Table 3, respectively. 
Table 1 
List of Tables 
Table Number 
Title 
Analysis Set 
Table A1.1 
Analysis of Time to TSC-associated Seizures from 
the Start of the Treatment Period 
ITT Analysis Set 
Table A1.2 
Analysis of Time to Total Seizures from the Start of 
the Treatment Period 
ITT Analysis Set 
Table A2 
Negative Binomial Regression Analysis of TSC-
associated Seizure Count During Baseline and 
Treatment Periods Using Worst Case of No 
Change or Observed Worsening for 25 mg/kg/day 
or 50 mg/kg/day Patients who Withdrew During the 
Treatment Period 
ITT Analysis Set 
Table A3.1.1 
Negative Binomial Regression Analysis of TSC-
associated Seizure Count During Baseline and by 
Cumulative Day in the Treatment Period 
ITT Analysis Set 
Table A3.1.2 
Analysis of TSC-associated Seizure Treatment 
Responders During the Treatment Period by 
Cumulative Day 
ITT Analysis Set 
Table A3.2.1 
Negative Binomial Regression Analysis of 
Convulsive Seizure Count During Baseline and by 
Cumulative Day in the Treatment Period - 25 
mg/kg/day and 50 mg/kg/day Pooled 
ITT Analysis Set 
Table A3.2.2 
Analysis of TSC-associated Seizure Treatment 
Responders During the Treatment Period by 
Cumulative Day - 25 mg/kg/day and 50 mg/kg/day 
Pooled 
ITT Analysis Set 
Table A4 
Summary of Dose During the Blinded Treatment 
Phase 
Safety Analysis Set 
 
 


Trial Code: GWEP1521 
EudraCT Number: 2015-002154-12 
ClinicalTrials.gov Identifier: NCT02544763 
SAP Addendum, Date: 28th November 2019 
 
 
 
 
GWEP1521    
 
Page 8 of 8 
 
 
Confidential 
 
Table 2 
List of Figures 
Figure Number 
Title 
Analysis Set 
Figure A1.1 
Cumulative Distribution Function for TSC-
associated Seizures During the Treatment Period - 
Patients Taking Clobazam 
ITT Analysis Set 
Figure A1.2 
Cumulative Distribution Function for TSC-
associated Seizures During the Treatment Period - 
Patients Not Taking Clobazam 
ITT Analysis Set 
Figure A2.1.1 
Kaplan-Meier Plot of Time to 10th TSC-associated 
Seizure from the Start of the Treatment Period 
(Day 1) 
ITT Analysis Set 
Figure A2.1.2 
Kaplan-Meier Plot of Time to 20th TSC-associated 
Seizure from the Start of the Treatment Period 
(Day 1) 
ITT Analysis Set 
Figure A2.2.1 
Kaplan-Meier Plot of Time to 10th Total Seizure 
from the Start of the Treatment Period (Day 1) 
ITT Analysis Set 
Figure A2.2.2 
Kaplan-Meier Plot of Time to 20th Total Seizure 
from the Start of the Treatment Period (Day 1) 
ITT Analysis Set 
 
Table 3 
List of Listings 
Figure Number 
Title 
Analysis Set 
Listing A1 
Dose During the Blinded Treatment Phase 
Safety Analysis Set