Clinical trial NCT04984278
Conditions: Spasticity With Multiple Sclerosis
Keywords: multiple sclerosis MS spasticity velocity-dependent muscle tone nabiximols
Sponsor: Jazz Pharmaceuticals
Start date: 2021-08-16; Completion date: 2022-11-11
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will be conducted to evaluate the effect of multiple doses of nabiximols compared with placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Lower Limb Muscle Tone-6 \[LLMT-6\]) in participants with multiple sclerosis (MS). LLMT-6 is defined as the average of the 6 individual Modified Ashworth Scale (MAS)-transformed scores of knee flexors, knee extensors, and plantar flexors on both sides of the body.

Detailed description:
Each period of this multicenter, randomized, double-blind, placebo-controlled, 2-treatment, 2-period, crossover trial includes a 7-day Baseline period, a 3-week treatment period (comprising a 2-week titration phase and a 1-week maintenance phase).

Eligible participants will enter the 7-day baseline period of each treatment period. During baseline, participants will maintain their optimized oral MS antispasticity medication regimen and record their 11-point Numerical Rating Scale (NRS) spasticity score and spasm count using an electronic daily diary. On Day 1, eligible participants will be randomized to 1 of 2 treatment sequences, each composed of 2 treatment periods, with administration of multiple doses of nabiximols or placebo in a 1:1 ratio.

Participants will be advised to titrate the investigational medicinal product (IMP), beginning with 1 spray/day, to an optimized dose or to a maximum of 12 sprays/day over the first 14 days of treatment. Participants should continue at the same dose level achieved at the end of the titration phase ±1 spray divided into a morning dose and an evening dose for the remainder of the treatment period.

Lower limb muscle tone, health-related quality of life, safety, tolerability, and pharmacokinetics will be evaluated during the treatment period.

Participants who complete the trial will participate for a total of approximately 11 weeks (77 days), including the 7-day baseline period.

Arms: arm 1: Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides. Study dependent: Each spray delivers 100 microliters (μL) of nabiximols. A pre-determined number of sprays, but no less than 4 sprays, of nabiximols will be self-administered by participants as an oromucosal spray, under supervision of trial staff during 2 study visits to the trial site after they temporarily discontinued treatment with prescribed nabiximols (Sativex) as part of their regular medication. arm 2: Placebo to match nabiximols is presented as an oromucosal spray containing the excipients ethanol and propylene glycol (50% v/v) with colorings and flavored with peppermint oil (0.05% v/v). Each spray delivers 100 μL containing no active ingredients.
Interventions: intervention 1: Nabiximols intervention 2: Placebo
Intervention descriptions: intervention 1: oromucosal spray intervention 2: oromucosal spray

Protocol documents:
Prot_000.pdf: 
Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
Confidential 
Page 1 of 94 
 
Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to 
Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures 
of Spasticity in Patients with Multiple Sclerosis 
 
Study Code: GWSP20105 
EudraCT Number: 2020-003271-18 
CLINICAL PROTOCOL 
 
GW Pharma Ltd 
Sovereign House 
Vision Park 
Chivers Way 
Histon 
Cambridge CB24 9BZ 
United Kingdom 
Tel: +44 (0) 1223 266 800 
Fax: +44 (0) 1223 235 667 
 
 
 
Confidentiality Statement 
This document contains confidential information of GW Pharma Ltd (GW) that must not be 
disclosed to anyone other than the recipient trial staff and members of the institutional review 
board or independent ethics committee. This information cannot be used for any purpose 
other than the evaluation or conduct of the clinical investigation without the prior written 
consent of GW. 


Study Code: GWSP20105
SPONSOR: GW PHARMA LIMITED
EudraCT Number: 2020-003271-18
GWSP20105_Protocol V1_22Jul2020
Confidential
Page 2 of 94
Clinical Protocol Template (Phase 2–4)
V1, 24Sep15
Investigator Agreement
I have read the attached clinical protocol entitled “A Randomized, Double-blind, Placebo-
controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on 
Clinical Measures of Spasticity in Patients with Multiple Sclerosis,” dated 22 July 2020 and
agree to abide by all provisions set forth therein.
I agree to comply with applicable regulatory requirement(s); the US 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 GCP Directive 
(2005/28/EC) and subsequent applicable regulatory/statutory instruments, or the International 
Council for 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 accept 
responsibility for the overall medical care of patients during the trial and for all trial-related 
medical decisions.
I am not aware that any conflicts of interest, financial or otherwise, exist for myself, my 
spouse (or legal partner) and dependent children and agree to confirm this in writing if 
required and update as necessary.
I agree to ensure that the confidential information contained in this document will not be used 
for any purpose other than the evaluation or conduct of the clinical investigation without the 
prior written consent of GW.
GW Authorization
Print name:
Date:
 Clinical Sciences
(DD Month YYYY)
Signature:
Trial site No:
Print name:
Date:
Principal investigator
(DD Month YYYY)
Signature:
	
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CCI
CCI
CCI


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
Confidential 
Page 3 of 94 
 
Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
1 
PROTOCOL SYNOPSIS 
Trial Title 
A Randomized, Double-blind, Placebo-controlled, 2-way Crossover 
Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on 
Clinical Measures of Spasticity in Patients with Multiple Sclerosis 
Clinical Trial Type 
Phase 3 
Indication 
Symptomatic treatment of spasticity in patients with multiple 
sclerosis (MS) 
Primary Objective 
To evaluate the effect of multiple doses of nabiximols compared with 
placebo on a clinical measure of velocity-dependent muscle tone in 
the lower limbs (Lower Limb Muscle Tone-6; LLMT-6) in patients 
with MS 
Secondary 
Objectives 
x To evaluate the effect of multiple doses of nabiximols compared 
with placebo on a clinical measure of velocity-dependent muscle 
tone in the lower limbs (Lower Limb Muscle Tone 4; LLMT-4) in 
patients with MS 
x To evaluate the safety and tolerability of nabiximols after 
administration of multiple doses 
x To evaluate the pharmacokinetic (PK) profile of nabiximols after 
administration of multiple doses 
Exploratory 
Objectives 
x To evaluate the effect of nabiximols after administration of 
multiple doses on walking using the Timed 25-Foot Walk 
(T25FW) test 
x To evaluate the effect of nabiximols after administration of 
multiple doses on the following patient-reported outcomes: 
 The 11-point Numerical Rating Scale (NRS) spasticity score 
 Daily spasm count 
 The MS Spasticity Scale (MSSS-88) total and subdomain 
scores 
Trial Design 
This multicenter, randomized, double-blind, placebo-controlled, 
2-treatment, 2-period, Phase 3 crossover trial is being conducted to 
evaluate the effect of multiple doses of nabiximols on clinical 
measures in the symptomatic treatment of patients with MS. 
Patients with spasticity associated with MS will participate in a 
screening period of up to 28 days; no changes in the dosing regimen 
of the patients’ current MS antispasticity medications, if any, will be 
made during this period. 
As part of the baseline period of each treatment period, patients will 
keep an electronic diary to record 11-point NRS spasticity score, 
spasm count, and use of antispasticity medications once daily, around 
the same time each day, preferably in the evening before retiring to 
sleep, for at least 7 days prior to Visits 2 and 6. At Visit 2, in the 
morning of Day 1, eligible patients will be randomly assigned in a 
1:1 ratio to 1 of 2 treatment sequences, each composed of 2 treatment 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
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Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
periods, with administration of multiple doses of nabiximols or 
placebo. 
Patients randomized will complete 2 treatment periods with 
administration of investigational medicinal product (IMP) for 21 days 
per treatment period. Each treatment period will consist of a dose-
titration phase of approximately 14 days, followed by a maintenance-
dose phase of approximately 7 days, where the individually 
determined optimized dose level remains unchanged for the 
remainder of each treatment period after titration. Doses greater than 
1 spray/day will be divided into a morning dose and an evening dose. 
Throughout both treatment periods, patients will initiate IMP 
treatment as a single spray in the clinic in the morning of Visits 2 
(Day 1) and 6 (Day 31) of each treatment period. Patients will 
gradually titrate their daily dose by 1 to 2 additional sprays/day to an 
optimized dose or to a maximum of 12 sprays/day over the first 
approximately 14 days of treatment with an approximately 15-minute 
interval between sprays. Patients should complete titration within 
approximately 14 days of their first dose of IMP in each treatment 
period and should continue at the same dose level achieved at the end 
of the titration phase (i.e., their daily optimized dose) ±1 spray 
divided into a morning dose and an evening dose for the remainder of 
the treatment period. Once a stable daily dose has been reached, 
patients should gradually decrease the interval between sprays to a 
target interval of approximately 1 minute between sprays. Patients 
will be advised to administer IMP at approximately the same time 
each day in a consistent manner in relation to food consumption. 
Morning and evening doses should be administered around the same 
time within 30 minutes after starting a snack or meal. 
On the days of scheduled Modified Ashworth Scale (MAS) 
assessments other than Visit 1 (i.e., Visits 2, 5, 6, and 9), patients will 
attend the trial site without having administered any IMP in the 
morning. On the day of MAS assessment, patients who are taking 
antispasticity therapy should take their regular morning dose at least 
1 hour before the administration of IMP. Administration of the 
morning dose of IMP with a standardized snack containing at least 
300 kcal (of which approximately 30 kcal is composed of fat) will 
occur at the trial site under the supervision of site staff; MAS 
assessments will occur at scheduled time points before (Visits 2 and 6 
[predose]) and after (Visits 2, 5, 6, and 9 [3 hours ±15 minutes 
postdose]) IMP administration. 
A washout period of at least 7 days will separate the 2 treatment 
periods. During the washout period, patients will continue to take 
their current MS antispasticity medications, if any, without any 
changes in dosing regimen. 
Patients who complete the 2 treatment periods will complete an End 
of Treatment Visit (Visit 9). Patients who discontinue IMP early will 
be encouraged to remain in the study for the duration of the treatment 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
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Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
period in which they discontinue IMP and will complete an End of 
Treatment Visit (Visit 9) at the end of that period. A Safety Follow-up 
Visit (Visit 10) will occur 7 (+ 3) days after the last dose of IMP or 
after the End-of-Treatment visit (Visit 9), whichever is later, for all 
patients. 
Primary Endpoint 
Change in Lower Limb Muscle Tone-6 (LLMT-6; defined as the 
average of the 6 individual MAS transformed scores of knee flexors, 
knee extensors, and plantar flexors on both sides of the body) from 
Day 1 predose to Day 21 and from Day 31 predose to Day 51 
The MAS scores are transformed using the following algorithm: MAS 
untransformed [to MAS transformed] scores; 0[0], 1[1], 1+[2], 2[3], 
3[4], and 4[5]. 
Secondary 
Endpoints 
Efficacy:  
x Change in Lower Limb Muscle Tone-4 (LLMT-4; defined as 
the average of the 4 individual MAS transformed scores of 
knee flexors and knee extensors on both sides of the body) 
from Day 1 predose to Day 21 and from Day 31 predose to 
Day 51 
Safety: 
x Frequency of treatment-emergent adverse events (TEAEs) 
x Change from baseline to each assessment time point by 
treatment period for the following: 
x Clinical laboratory parameters 
x Vital signs 
x Physical examination procedures 
x 12-lead electrocardiograms (ECGs) 
x Columbia-Suicide Severity Rating Scale (C-SSRS) at 
screening, and at each subsequent time point with reference to 
the last assessment (since last visit) 
Pharmacokinetics: 
x 3ODVPDFRQFHQWUDWLRQVIRUǻ9-tetrahydrocannabinol (THC) and 
its relevant metabolites (11-hydroxy-ǻ9-tetrahydrocannabinol 
and 11-carboxy-ǻ9-tetrahydrocannabinol) and 
cannabidiol (CBD) and its relevant metabolites (7-hydroxy-
cannabidiol and 7-carboxy-cannabidiol) at distinct time points 
during each treatment period (Visits 2, 4, 5, 6, 8, and 9) 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
Confidential 
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Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
Exploratory 
Endpoints 
Efficacy: 
x Change in Timed 25-Foot Walk (T25FW) test from Day 1 
predose to Day 21 and from Day 31 predose to Day 51 
x Average 11-point NRS spasticity score over the last 7 days of 
each double-blind treatment period 
x Average daily spasm count over the last 7 days of each 
double-blind treatment period 
x Total and subdomain scores of the MSSS-88 at the end of the 
maintenance-dose phase of each double-blind treatment period 
Sample Size 
The trial will consist of 2 treatment sequences. A total of 
approximately 190 patients will be required. Approximately 
95 patients will be randomly assigned to each treatment sequence to 
ensure that at least 170 patients in total complete the 2 treatment 
periods. This assumes a true difference of -0.18, and standard 
deviation (SD) for paired differences of 0.71 for 90% power. 
If more than 20 patients withdraw from the study, additional patients 
will be enrolled to have at least 170 completers. 
Additional data, collected outside of this trial, may become available 
during study conduct. Based on such data, the sample size may be 
recalculated using a blinded reassessment and updated assumptions of 
treatment effect and variability, while maintaining study blind and 
type 1 error. 
Summary of Patient 
Eligibility Criteria 
Inclusion Criteria 
Screening (Visit 1) 
For inclusion in the trial, patients must fulfill ALL of the following 
criteria: 
x Male or female, aged 18 years or above. 
x Willing and able to give informed consent for participation in 
the trial. 
x Willing and able (in the investigator’s opinion) to comply with 
all trial requirements. 
x Has had a diagnosis with any disease subtype of MS, by 
revised 2017 McDonald criteria, for at least 12 months prior to 
Visit 1 and is expected to remain stable for the duration of the 
trial. 
x Has an MAS untransformed score of at least 2 in 2 or more of 
6 muscle groups (right knee flexors, left knee flexors, right 
knee extensors, left knee extensors, right plantar flexors, or 
left plantar flexors) at Visit 1. 
x If currently receiving approved anti-spasticity therapy, it must 
be with a stable dosing regimen for at least 30 days prior to 
Visit 1. The patient must be willing to maintain the same 
antispasticity medication and not plan to initiate a new course 
of physiotherapy for the duration of the trial. 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
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Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
x If currently receiving an approved MS disease-modifying 
therapy, it must be at a stable dose for at least 3 months prior 
to Visit 1 and be expected to remain stable for the duration of 
the trial.  
x If currently receiving dalfampridine or fampridine, it must be 
at a stable dose for at least 3 months prior to Visit 1 and is 
expected to remain stable for the duration of the trial. 
x Willing to allow the responsible authorities to be notified of 
participation in the trial, if mandated by local law. 
x Willing to allow his or her primary care practitioner (if he or 
she has one) and/or treating neurologist (if he or she has one) 
to be notified of participation in the trial, if the primary care 
practitioner/treating neurologist is different from the 
investigator. 
Additional Inclusion Criteria at Randomization (Visit 2) 
Patients are eligible for randomization in the trial if, in addition to 
continuing to meet the Screening (Visit 1) inclusion criteria, they also 
meet the following criterion prior to Visit 2 (Day 1): 
x Completed at least 5 of 7 days of their electronic diary 
reporting during the 7 days immediately preceding Visit 2 
(Day 1). 
Exclusion Criteria 
The patient may not enter the trial if ANY of the following apply: 
x Has taken nabiximols, cannabis, or a cannabis-derived product 
for medicinal or recreational purposes in the 30 days prior to 
Visit 1 or unable to abstain for the duration of the study. 
x Did not tolerate or did not respond adequately to treatment 
with nabiximols or another cannabis-based medication if 
exposed at any time before the 30-day period prior to Visit 1. 
x Any concomitant disease or disorder that has spasticity-like 
symptoms or that may influence the patient’s level of 
spasticity. 
x Medical history suggests that relapse/remission is likely to 
occur during the trial, which, in the opinion of the 
investigator, is expected to influence the patient’s spasticity. 
x Has had a relapse of MS within the 60 days prior to Visit 1. 
x Currently using botulinum toxin injection for the relief of 
spasticity (within 6 months of Visit 1) or is unwilling to 
abstain for the duration of the trial. 
x Currently taking antipsychotic medication. 
x Currently taking benzodiazepines unless doses and dosing 
regimen have been stable for at least 30 days prior to Visit 1. 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
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Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
x Clinically suspected to have a contracture in one of the muscle 
groups of the lower limbs, preventing assessment with the 
MAS. 
x Has any known or suspected hypersensitivity to cannabinoids 
or any of the excipients of the IMP. 
x Has experienced myocardial infarction or clinically significant 
cardiac dysfunction within the 12 months prior to Visit 1 or 
has a cardiac disorder that, in the opinion of the investigator, 
would put the patient at risk of a clinically significant 
arrhythmia or myocardial infarction. 
x Has a diastolic blood pressure of < 50 mmHg or > 105 mmHg 
or systolic blood pressure < 90 mmHg or > 150 mmHg (when 
measured in a sitting position at rest for 5 minutes) or a 
postural drop in the systolic blood pressure of > 20 mmHg at 
Visit 1 or Visit 2. All measurements will be performed singly 
and can be repeated once, if any are outside the reference 
range but not considered clinically significant. 
x Has clinically significant impaired renal function at Visit 1, as 
evidenced by an estimated creatinine clearance lower than 
50 mL/min. All measurements will be performed singly and 
can be repeated once, if any are outside the reference range 
but not considered clinically significant. 
x Has moderately impaired hepatic function at Visit 1, defined 
as serum alanine aminotransferase (ALT) or aspartate 
aminotransferase (AST) > 2 × upper limit of normal (ULN). 
All measurements will be performed singly and can be 
repeated once, if any are outside the reference range but not 
considered clinically significant. 
x Male and fertile (i.e., after puberty unless permanently sterile 
by bilateral orchiectomy) unless willing to ensure that he uses 
male contraception (condom or vasectomy) or remains 
sexually abstinent during the trial and for 3 months thereafter. 
x Female and of childbearing potential (i.e., following menarche 
DQGXQWLOEHFRPLQJSRVWPHQRSDXVDOIRU 12 consecutive 
months unless permanently sterile by hysterectomy, bilateral 
salpingectomy, or bilateral oophorectomy) unless willing to 
ensure that she uses a highly effective method of birth control 
(e.g., intrauterine device/hormone-releasing system, bilateral 
tubal occlusion, vasectomized partner, or sexual abstinence) 
during the trial and for 3 months thereafter. Patients using 
combined hormonal methods or a progestogen-only pill or 
injection or implant should use an additional barrier method 
such as a male condom or diaphragm during the trial and for 
3 months thereafter. 
x Female and pregnant (positive pregnancy test at Visit 1 or 
Visit 2), lactating, or planning pregnancy during the course of 
the trial or within 3 months thereafter. 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
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Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
x Has received an IMP within the 30 days prior to Visit 1. 
x Has any other clinically significant disease or disorder 
(including seizure disorder) that, in the opinion of the 
investigator, may put the patient, other patients, or site staff at 
risk because of participation in the trial, influence the 
interpretation of trial results, or may affect the patient’s ability 
to take part in the trial. 
x Has any abnormalities identified following a physical 
examination, clinical laboratory, serology, or other applicable 
screening procedures that, in the opinion of the investigator, 
would jeopardize the safety of the patient or the conduct of the 
study if he or she took part in the trial. 
x Has any history of suicidal behavior in the 5 years prior to 
Visit 1 or a score of 3, 4, or 5 on the C-SSRS in the month 
prior to Visit 1. 
x Has donated blood during the 3 months prior to Visit 1 and is 
unwilling to abstain from donation of blood during the trial. 
x Has been previously randomized into this trial. 
x Has any known or suspected history of alcohol or substance 
abuse (including opiate abuse) or dependence within 1 year 
prior to Visit 1. 
x Currently using an illicit drug or current nonprescribed use of 
any prescription drug. 
x Has a history of psychiatric or neurologic disorder that, in the 
opinion of the investigator, may interfere with trial 
participation, data interpretation, or conduct of trial 
procedures. 
x Has a history of severe psychiatric disorder that may be 
exacerbated by the use of a cannabinoid-containing product. 
x Has any planned clinical interventions or intends to change 
any or all medications that may have an effect on spasticity or 
MS during the trial. 
x Currently taking drugs that are solely metabolized by 
UGT1A9 and UGT2B7. 
x 
Currently taking strong CYP3A4 inducers (e.g., rifampicin, 
carbamazepine, phenytoin, phenobarbital, St John's Wort). 
Criteria for 
Withdrawal 
The patient must be withdrawn from the trial if any of the following 
apply: 
x Administrative decision by the investigator, GW Pharma Ltd, 
or regulatory authority 
x Withdrawal of patient consent 
x Lost to follow-up 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
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Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
The patient must cease IMP and should remain in the trial if any of 
the following apply: 
x Pregnancy 
x Protocol deviation that is considered to potentially 
compromise the safety of the patient 
x Suicidal behavior or ideation of type 4 or 5 during the 
treatment period, as evaluated with the C-SSRS 
x ALT or AST > 3 × ULN with the appearance of fatigue, 
nausea, vomiting, right upper quadrant pain or tenderness, 
fever, rash, and/or eosinophilia (> 5%) 
x ALT or AST > 5 × ULN 
x ALT or AST > 3 × ULN and (total bilirubin 
[TBL] > 2 × ULN or international normalized ratio 
[INR] > 1.5) 
The patient may be required to cease IMP at the discretion of the 
investigator and should remain in the trial for any of the following 
reasons: 
x Did not meet eligibility criteria 
x Patient noncompliance 
x AE (including clinically significant laboratory result) that, in 
the opinion of the investigator, would compromise the 
continued safe participation of the patient in the trial 
x Any evidence of drug abuse or diversion 
x Disease progression (defined as a relapse of MS requiring a 
change in treatment) 
Investigational 
Medicinal Product: 
Formulation, Mode 
of Administration, 
Dose and Regimen 
Nabiximols oromucosal spray is a mixture of THC and CBD extracts 
derived from Cannabis sativa L. Each of the botanical extracts 
contains a cannabinoid as the major constituent (i.e., THC or CBD) 
and minor constituents including other cannabinoid and 
noncannabinoid plant components, including alpha- and trans-
caryohyllenes, other terpenes, sterols, and triglycerides. 
Nabiximols is presented as an oromucosal spray containing THC 
(27 mg/mL):CBD (25 mg/mL) as well as other non-cannabinoid plant 
components, dissolved in ethanol:propylene glycol (50% v/v) 
excipients with peppermint oil (0.05% v/v) flavoring. Each spray 
delivers 100 ȝ/RIQDEL[LPROV. 
Placebo to match nabiximols is presented as an oromucosal spray 
containing the excipients ethanol and propylene glycol (50% v/v) 
with colorings and flavored with peppermint oil (0.05% v/v). Each 
VSUD\GHOLYHUVȝ/FRQWDLQLQJQRDFWLYHLQJUHGLHQWV 
Treatment will be initiated in the clinic in the morning of Visits 2 
(Day 1) and 6 (Day 31) of each treatment period. The total daily dose 
should be administered as a morning dose and an evening dose, which 
may be composed of a different number of sprays during titration. 
Patients will be advised to administer IMP at approximately the same 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
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Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
time each day in a consistent manner in relation to food consumption. 
Morning and evening doses should be administered around the same 
time within 30 minutes after starting a snack or meal. Patients will 
gradually titrate their daily dose to the maximally acceptable dose, 
balancing efficacy and tolerability, or to a maximum number of 12 
sprays/day. During the titration phase, there should be an 
approximately 15-minute interval between sprays. 
Patients should complete titration within approximately 14 days of 
their first dose of IMP in each treatment period and should continue at 
the same dose level achieved at the end of titration phase (i.e., their 
daily optimized dose) ±1 spray/day divided into a morning dose and 
an evening dose for the remainder of the treatment period. 
Once a stable daily dose has been reached, patients should gradually 
decrease the interval between sprays to a target interval of 
approximately 1 minute between sprays. 
Throughout each treatment period, patients will be advised to 
administer IMP at approximately the same time each day in a 
consistent manner in relation to food consumption. 
Control Arm 
All patients enrolled in the trial will receive both nabiximols and 
placebo during the 2-way crossover treatment period. 
Procedures 
Assessments/procedures at the trial site include the following: 
x Informed consent, demographics, previous cannabis use, medical 
history, electronic diary training, and blood THC test (Visit 1) 
x Eligibility check and urine drug screen (including THC) (Visits 1 
and 2 [predose]) 
x Randomization and IMP dosing training (Visit 2 [predose]) 
x Concomitant medications review, AE review, and vital signs 
(when at the trial site) measurement (Visits 1 through 10) 
x Physical examination (including height measurement at Visit 1 
only), 12-lead ECG, and clinical laboratory blood sampling 
(hematology and biochemistry) (Visits 1, 5, and 9) 
x Examination of oral mucosa (Visits 1, 2 [predose], 4, 5, 
6 [predose], 8, 9, and 10) 
x Body weight measurement (Visits 1, 2 [predose], 6 [predose], and 
10) 
x Dipstick urinalysis and serum pregnancy test (if appropriate) 
(Visits 1 and 10) 
x Urine pregnancy test (if appropriate) (Visits 2 and 6 [predose]) 
x PK blood sampling (IMP) at distinct time points (Visits 2, 4, 5, 6, 
8, and 9) 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
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Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
x MAS assessment (Visits 1, 2 [predose and at 3 hours ±15 minutes 
postdose], 5 [3 hours ±15 minutes after the first spray of the 
morning dose], 6 [predose and at 3 hours ±15 minutes postdose], 
and 9 [3 hours ±15 minutes after the first spray of the morning 
dose]) 
x MSSS-88 assessment (Visits 5 and 9) 
x T25FW test (Visits 2 [predose], 5, 6 [predose], and 9) 
x C-SSRS assessment (Visits 1, 2 [predose], 4, 5, 6 [predose], 8, 9, 
and 10) 
x IMP dosing at the investigational site (Visits 2, 5, 6, and 9) 
x IMP dispensing (Visits 2, 4, 6, and 8) 
x IMP collection and compliance review (Visits 4, 5, 8, and 9) 
Additional procedures to screen for the presence of or immunity 
against infectious diseases may be conducted according to local 
guidance and policy. In cases where patients are not able to attend 
study visits due to the presence of an infectious disease or other 
transmissible condition, the investigator will discuss with the Sponsor 
potential mitigation approaches. 
Scheduled Phone Calls 
Site staff will call patients 7±1 days after the first dose of IMP during 
each treatment period (Visits 3 and 7) to monitor adherence with IMP 
administration and advise on dose titration if required. Concomitant 
medications and AEs will be collected during this call. 
Patient Electronic Diary Assessments 
Patients will complete their electronic diary once daily, around the 
same time each day, preferably in the evening before retiring to sleep, 
for at least the 7 days prior to Visits 2 and 6 and throughout the trial 
until Visit 9, unless otherwise indicated, and the following 
assessments will be conducted: 
x 11-point NRS for spasticity 
x Spasm count 
x Use of antispasticity medications 
x IMP dosing record (Visits 2 through 9) 
x Dosing in relation to food (the day before Visits 4, 5, 8, and 9 
only) 
Statistical 
Considerations 
The Lower Limb Muscle Tone-6 (LLMT-6) will be derived as the 
average of individual MAS transformed scores (of left knee flexors, 
right knee flexors, left knee extensors, right knee extensors, left 
plantar flexors, and right plantar flexors) for each patient. The change 
from baseline in LLMT-6 in treatment period 1 for each patient will 
be derived as LLMT-6 at Day 21 minus LLMT-6 at Day 1 predose 
and the change from baseline in LLMT-6 in treatment period 2 for 
each patient will be derived as LLMT-6 at Day 51 minus LLMT-6 at 
Day 31 predose.The primary estimand involves the mean treatment 


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Clinical Protocol Template (Phase 2–4) 
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difference between the mean change from baseline in LLMT-6 while 
on nabiximols and the mean change from baseline in LLMT-6 while 
on placebo. The changes from baseline in LLMT-6 will be analyzed 
using a linear mixed effects model for crossover data. The model will 
include a period level baseline covariate and treatment, period, and 
treatment sequence as fixed effects and patient nested within 
treatment sequence as a random effect.Secondary endpoints and 
exploratory endpoints will be analyzed based on the statistical 
analysis plan. 
Statistical hypothesis testing will be 2-tailed and carried out at the 5% 
level of significance. Testing will be performed on the primary 
endpoint, secondary endpoints, and exploratory endpoints as 
appropriate. 
To control for Type 1 error, the primary efficacy endpoint and the 
secondary efficacy endpoint will be tested hierarchically, starting with 
the primary efficacy endpoint and followed by the secondary efficacy 
endpoint. No adjustments for multiplicity will be made for the other 
secondary or exploratory endpoints. 
Safety data will be summarized using appropriate statistical methods. 
Additional data, collected outside of this trial, may become available 
during study conduct. Based on such data, the statistical approach for 
this study may be amended based on updated assumptions of 
treatment effect and variability, while maintaining study blind and 
type 1 error. 
Sponsor 
GW Pharma Ltd 
Sovereign House 
Vision Park 
Chivers Way 
Histon 
Cambridge CB24 9BZ 
United Kingdom 
 


Study Code: GWSP20105 
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Clinical Protocol Template (Phase 2–4) 
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Figure 1-1 
Trial Design and Treatment Schematic 
 
 


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Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
Table of Contents 
Title Page..............................................................................................................1 
1 
PROTOCOL SYNOPSIS .......................................................................... 3 
Table of Contents .............................................................................................. 15 
List of Appendices ............................................................................................. 20 
List of In-text Tables ......................................... Error! Bookmark not defined. 
List of In-text Figures ....................................... Error! Bookmark not defined. 
List of Abbreviations ........................................................................................ 22 
Definition of Terms ........................................................................................... 24 
2 
OBJECTIVES .......................................................................................... 25 
2.1 
Objectives and Endpoints ........................................................................................ 25 
3 
BACKGROUND AND RATIONALE ................................................... 27 
3.1 
Disease..................................................................................................................... 27 
3.2 
Nabiximols Background .......................................................................................... 28 
3.3 
Rationale .................................................................................................................. 28 
3.4 
Clinical Hypothesis ................................................................................................. 28 
4 
EXPERIMENTAL PLAN ....................................................................... 30 
4.1 
Trial Design ............................................................................................................. 30 
4.2 
Number of Sites ....................................................................................................... 31 
4.3 
Number of Patients .................................................................................................. 31 
5 
INVESTIGATIONAL MEDICINAL PRODUCT ............................... 32 
5.1 
Nabiximols .............................................................................................................. 32 
5.2 
Placebo .................................................................................................................... 32 
5.3 
Packaging, Storage, and Drug Accountability ........................................................ 32 
5.3.1 
Packaging and Labeling ........................................................................................ 32 
5.3.2 
Storage .................................................................................................................. 33 
5.3.3 
Supply and Return of Investigational Medicinal Product ..................................... 33 
5.3.4 
Investigational Medicinal Product Accountability ............................................... 34 
5.3.5 
Post-trial Provision ............................................................................................... 35 
6 
PATIENT ELIGIBILITY ....................................................................... 36 
6.1 
Inclusion Criteria ..................................................................................................... 36 
6.2 
Exclusion Criteria .................................................................................................... 37 


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7 
PATIENT ENROLLMENT .................................................................... 40 
7.1 
Treatment Assignment ............................................................................................ 40 
7.2 
Randomization......................................................................................................... 40 
8 
TREATMENT PROCEDURES ............................................................. 41 
8.1 
Investigational Medicinal Product Dosage, Administration, and Schedule ............ 41 
8.1.1 
Dose Administration ............................................................................................. 41 
8.1.2 
Dose Escalation and Dose Adjustments ............................................................... 42 
8.2 
Washout Period ....................................................................................................... 43 
8.3 
Concomitant Therapy .............................................................................................. 43 
8.3.1 
Concomitant Antispasticity Medications .............................................................. 43 
8.4 
Prohibited Therapy During Trial Period ................................................................. 43 
8.5 
Compliance in Investigational Medicinal Product Administration ......................... 44 
8.6 
Access to Blinded Treatment Assignment .............................................................. 44 
9 
TRIAL PROCEDURES .......................................................................... 45 
9.1 
Trial Procedures by Visit ......................................................................................... 45 
9.1.1 
Screening (Visit 1 [Days -28 to -1]) ..................................................................... 45 
9.1.1.1 
Screening Failures ............................................................................................. 46 
9.1.2 
Treatment Period 1 (Visits 2 to 5 [Days 1 to 21]) ................................................ 47 
9.1.2.1 
Visit 2 (Day 1) ................................................................................................... 47 
9.1.2.2 
Visit 3 (Day 8, Phone Call) ............................................................................... 48 
9.1.2.3 
Visit 4 (Day 15) and Visit 5 (Day 21) ............................................................... 48 
9.1.3 
Washout Period (Days 22 to 30) ........................................................................... 49 
9.1.4 
Treatment Period 2 (Visits 6 to 9 [Days 31 to 51]) .............................................. 50 
9.1.4.1 
Visit 6 (Day 31) ................................................................................................. 50 
9.1.4.2 
Visit 7 (Day 38, Phone Call) ............................................................................. 51 
9.1.4.3 
Visit 8 (Day 45) and Visit 9 (Day 51, End of Treatment)................................. 51 
9.1.5 
Safety Follow-up Visit (Visit 10 [Day 58]) .......................................................... 52 
9.2 
Trial Procedure Listing ............................................................................................ 53 
9.2.1 
Informed Consent ................................................................................................. 53 
9.2.2 
Contraception Requirements ................................................................................ 53 
9.2.3 
Demographics ....................................................................................................... 54 
9.2.4 
Previous Cannabis Use ......................................................................................... 54 
9.2.5 
Medical History .................................................................................................... 54 
9.2.6 
Concomitant Medication ...................................................................................... 54 


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9.2.7 
Physical Examination ........................................................................................... 55 
9.2.8 
Examination of Oral Mucosa ................................................................................ 55 
9.2.9 
Body Weight Measurements ................................................................................. 55 
9.2.10 
Vital Signs ............................................................................................................ 55 
9.2.11 
12-Lead Electrocardiogram .................................................................................. 55 
9.2.12 
Clinical Laboratory Sampling............................................................................... 55 
9.2.12.1 
Pharmacokinetic Blood Sampling ..................................................................... 57 
9.2.13 
Interactive Response Technology ......................................................................... 57 
9.2.14 
Electronic Patient Diary ........................................................................................ 57 
9.2.14.1 
Electronic Diary Training ................................................................................. 58 
9.2.14.2 
Spasticity Numerical Rating Scale .................................................................... 58 
9.2.14.3 
Use of Antispasticity Medications and Investigational Medicinal 
Product Dosing Record ..................................................................................... 58 
9.2.15 
Questionnaires and Assessments Completed at Scheduled Visits ........................ 58 
9.2.15.1 
Modified Ashworth Scale ................................................................................. 59 
9.2.15.2 
Multiple Sclerosis Spasticity Scale ................................................................... 59 
9.2.15.3 
Columbia-Suicide Severity Rating Scale .......................................................... 59 
9.2.15.4 
Timed 25-Foot Walk ......................................................................................... 60 
9.2.16 
Investigational Medicinal Product Accountability ............................................... 60 
9.2.17 
Adverse Events ..................................................................................................... 60 
9.2.18 
Subject Discontinuation ........................................................................................ 60 
9.2.19 
Special Circumstances .......................................................................................... 60 
10 
WITHDRAWAL ...................................................................................... 62 
11 
URGENT SAFETY MEASURES .......................................................... 64 
12 
ADVERSE EVENT REPORTING ........................................................ 65 
12.1 
Definitions ............................................................................................................... 65 
12.1.1 
Adverse Event ....................................................................................................... 65 
12.1.2 
Investigator ........................................................................................................... 65 
12.2 
Serious Adverse Events ........................................................................................... 65 
12.3 
Reporting Procedures for Serious Adverse Events ................................................. 66 
12.4 
Pregnancy ................................................................................................................ 67 
12.5 
Causality Assessment .............................................................................................. 67 
12.6 
Reporting Procedures for All Adverse Events ........................................................ 68 
12.7 
Follow-up Procedures for Adverse Events .............................................................. 69 


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Clinical Protocol Template (Phase 2–4) 
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12.8 
Potential Cases of Drug-induced Liver Injury ........................................................ 70 
12.9 
Notification of Safety Information to Investigators, Regulatory 
Authorities, and Institutional Review Boards/Independent Ethics 
Committees .............................................................................................................. 71 
13 
STATISTICAL CONSIDERATIONS ................................................... 73 
13.1 
Sample Size, Power, and Significance Levels ........................................................ 73 
13.2 
Interim Analysis ...................................................................................................... 73 
13.3 
Analysis Sets ........................................................................................................... 73 
13.3.1 
Protocol Deviations .............................................................................................. 74 
13.4 
General Considerations ........................................................................................... 74 
13.5 
Accountability and Background Characteristics ..................................................... 74 
13.5.1 
Enrollment and Disposition .................................................................................. 74 
13.5.2 
Baseline and Demographic Characteristics .......................................................... 74 
13.5.3 
Medical History .................................................................................................... 75 
13.5.4 
Concomitant Medication ...................................................................................... 75 
13.6 
Endpoints and Statistical Methods .......................................................................... 75 
13.6.1 
Evaluable Period ................................................................................................... 75 
13.6.2 
Primary Endpoint .................................................................................................. 75 
13.6.3 
Secondary Efficacy Endpoint ............................................................................... 76 
13.6.4 
Exploratory Efficacy Endpoints ........................................................................... 76 
13.6.5 
Pharmacokinetics .................................................................................................. 76 
13.6.6 
Safety .................................................................................................................... 77 
13.6.6.1 
Treatment Compliance and Extent of Treatment Exposure .............................. 77 
13.6.6.2 
Adverse Events.................................................................................................. 77 
13.6.6.3 
Clinical Laboratory Data ................................................................................... 77 
13.6.6.4 
Vital Signs, 12-Lead Electrocardiogram, Physical Examination, and 
Other Safety Data .............................................................................................. 78 
14 
DATA SAFETY MONITORING COMMITTEE ................................ 79 
15 
REGULATORY AND ETHICAL OBLIGATIONS ............................ 80 
15.1 
Declaration of Helsinki ........................................................................................... 80 
15.2 
Informed Consent .................................................................................................... 80 
15.3 
Institutional Review Board/Independent Ethics Committee ................................... 80 
15.4 
Pretrial Documentation Requirements .................................................................... 81 
15.5 
Patient Confidentiality ............................................................................................. 81 
16 
ADMINISTRATIVE AND LEGAL OBLIGATIONS ......................... 83 


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16.1 
Protocol Amendments and End of Trial or Termination ......................................... 83 
16.2 
Trial Documentation and Storage ............................................................................ 83 
16.3 
Trial Monitoring and Data Collection ..................................................................... 84 
16.4 
Quality Assurance ................................................................................................... 85 
16.5 
Compensation .......................................................................................................... 85 
16.6 
Publication Policy.................................................................................................... 85 
16.7 
Intellectual Property Rights ..................................................................................... 86 
16.8 
Confidential Information ......................................................................................... 86 
17 
REFERENCES ......................................................................................... 87 
 


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Clinical Protocol Template (Phase 2–4) 
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List of Appendices 
Appendix 1 
SCHEDULE OF ASSESSMENTS ........................................ 88 
Appendix 2 
TRIAL PERSONNEL ............................................................. 92 
Appendix 2.1 
Investigator Details .................................................................................... 92 
Appendix 2.2 
Sponsor Contact Details ............................................................................. 92 
Appendix 2.3 
Contract Research Organizations ............................................................... 92 
Appendix 3 
QUESTIONNAIRES/ASSESSMENTS ................................. 93 
Appendix 4 
PROHIBITED MEDICATIONS SOLELY 
METABOLIZED BY UGT1A9 AND UGT2B7 .................................... 94 
Appendix 4.1 
Prohibited Medications Metabolized Solely by UGT1A9 ......................... 94 
Appendix 4.2 
Prohibited Medications Metabolized Solely by UGT2B7 ......................... 94 
 


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Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
List of In-text Tables 
Table 2-1 
Objectives and Endpoints ........................................................ 25 
Table 8.1.2-1 
Example Titration Schedule ..................................................... 42 
Table 9.2.12-1 
Biochemistry, Hematology, Urinalysis, Pregnancy Test, and 
Drug Screen ............................................................................. 56 
Table 9.2.12.1-1 
Pharmacokinetic Blood Sampling Schedule ............................ 57 
 
List of In-text Figures 
Figure 1-1 
Trial Design and Treatment Schematic.................................... 14 
 


Study Code: GWSP20105 
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Clinical Protocol Template (Phase 2–4) 
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List of Abbreviations 
11-COOH-THC 
11-carboxy-ǻ9-tetrahydrocannabinol 
11-OH-THC 
11-hydroxy-ǻ9-tetrahydrocannabinol 
7-COOH-CBD 
7-carboxy-cannabidiol  
7-OH-CBD 
7-hydroxy-cannabidiol 
AD 
Assistive device 
AE 
Adverse event 
ALT 
Alanine aminotransferase 
AST 
Aspartate aminotransferase 
BDS 
Botanical drug substance 
CBD 
Cannabidiol 
CI 
Confidence interval 
CIOMS 
Council for International Organizations of Medical Sciences 
CRO 
Contract research organization 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EU 
European Union 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GW 
GW Pharma Ltd 
IB 
Investigator Brochure 
ICF 
Informed consent form 
ICH 
International Council for Harmonisation 
IEC 
Independent ethics committee 
IMP 
Investigational medicinal product 
INR 
International normalized ratio 
IRB 
Institutional review board 
IRT 
Interactive response technology 
LLMT-4 
Lower Limb Muscle Tone-4 
LLMT-6 
Lower Limb Muscle Tone-6 
MAS 
Modified Ashworth Scale 
MS 
Multiple sclerosis 


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Clinical Protocol Template (Phase 2–4) 
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MSSS-88 
Multiple Sclerosis Spasticity Scale 
NRS 
Numerical Rating Scale 
 
 
PI 
Principal investigator 
PK 
Pharmacokinetic 
PP 
Per Protocol 
PRN 
As-needed 
PT 
Preferred term 
PVD 
Pharmacovigilance department 
QoL 
Quality of life 
R2 
Relaxation Index 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SD 
Standard deviation 
SOC 
System organ class 
SUSAR 
Suspected unexpected serious adverse reaction 
T25FW 
Timed 25-Foot Walk 
TBL 
Total bilirubin 
TEAE 
Treatment-emergent adverse event 
THC 
ǻ9-Tetrahydrocannabinol 
ULN 
Upper limit of normal 
US 
United States 
 


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Clinical Protocol Template (Phase 2–4) 
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Definition of Terms 
Term 
Definition 
Clonus 
A clinical manifestation of spasticity described as self-sustained 
rhythmic involuntary muscular contractions and relaxations in 
response to a muscle stretch 
Completer 
A patient who completes both treatment periods 
Day 1 
The day a patient first receives investigational medicinal product 
in this trial 
End of trial 
Last patient last visit or last contact, whichever occurs last 
Enrolled patient 
Any patient who has provided written informed consent to take 
part in the trial 
International normalized 
ratio 
A calculation made to standardize prothrombin time 
Investigational medicinal 
product 
Term used to describe both investigational active product and 
reference therapy (placebo) 
Investigator 
Trial principal investigator or a formally delegated trial physician 
Lower Limb Muscle 
Tone-4 
A measure of velocity-dependent muscle tone in the lower limbs 
consisting of the average of the 4 individual MAS transformed 
scores of knee flexors and knee extensors on both sides of the 
body 
Lower Limb Muscle 
Tone-6 
A measure of velocity-dependent muscle tone in the lower limbs 
consisting of the average of the 6 individual MAS transformed 
scores of knee flexors, knee extensors, and plantar flexors on 
both sides of the body 
Spasm 
A clinical manifestation of spasticity described as a sudden, 
involuntary contraction of a muscle 
Spasticity 
A velocity-dependent increase in muscle tone resulting from an 
upper motor neuron lesion. Clinically, spasticity manifests as 
muscle stiffness or tightness, increased tendon reflexes, clonus, 
and flexor and extensor spasms 
Standardized snack 
A meal containing at least 300 kcal (of which approximately 
30 kcal is composed of fat) 


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Clinical Protocol Template (Phase 2–4) 
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2 
OBJECTIVES 
2.1 
Objectives and Endpoints 
An overview of objectives and endpoints is shown in Table 2-1. 
Table 2-1 
Objectives and Endpoints 
Primary Objective 
Primary Endpoint  
x To evaluate the effect of 
multiple doses of nabiximols 
compared with placebo on a 
clinical measure of 
velocity-dependent muscle tone 
in the lower limbs (Lower 
Limb Muscle Tone-6; LLMT-
6) in patients with multiple 
sclerosis (MS) 
x 
Change in Lower Limb Muscle Tone-6 
(LLMT-6; defined as the average of the 
6 individual MAS transformed scores of knee 
flexors, knee extensors, and plantar flexors on 
both sides of the body) from Day 1 predose to 
Day 21 and from Day 31 predose to Day 51 
 
Secondary Objectives 
Secondary Endpoints 
x To evaluate the effect of 
multiple doses of nabiximols 
compared with placebo on a 
clinical measure of 
velocity-dependent muscle tone 
in the lower limbs (Lower 
Limb Muscle Tone-4; LLMT-
4) in patients with MS 
x Change in Lower Limb Muscle Tone-4 
(LLMT-4; defined as the average of the 
4 individual MAS transformed scores of knee 
flexors and knee extensors on both sides of the 
body) from Day 1 predose to Day 21 and from 
Day 31 predose to Day 51 
x To evaluate the safety and 
tolerability of nabiximols after 
administration of multiple 
doses 
x Frequency of treatment-emergent adverse events 
(TEAEs) 
x Change from baseline to each assessment time 
point by treatment period for the following: 
 Clinical laboratory parameters 
 Vital signs 
 Physical examination procedures 
 12-lead electrocardiograms (ECGs) 
x Columbia-Suicide Severity Rating Scale 
(C-SSRS) at screening, and at each subsequent 
time point with reference to the last assessment 
(since last visit) 


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Clinical Protocol Template (Phase 2–4) 
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Table 2-1 
Objectives and Endpoints 
x To evaluate the 
pharmacokinetic (PK) profile 
of nabiximols after 
administration of multiple 
doses 
x Plasma concentrations for 
ǻ9-tetrahydrocannabinol (THC) and its relevant 
metabolites 
(11-hydroxy-ǻ9-tetrahydrocannabinol and 
11-carboxy-ǻ9-tetrahydrocannabinol) and 
cannabidiol (CBD) and its relevant metabolites 
(7-hydroxy-cannabidiol and 
7-carboxy-cannabidiol) at distinct time points 
during each treatment period (Visits 2, 4, 5, 6, 8, 
and 9) 
Exploratory Objectives 
Exploratory Endpoints 
x To evaluate the effect of 
nabiximols after administration 
of multiple doses on walking 
using the Timed 25-Foot Walk 
(T25FW) test 
x Change in Timed 25-Foot Walk (T25FW) test 
from Day 1 predose to Day 21 and from Day 31 
predose to Day 51 
x To evaluate the effect of 
nabiximols after administration 
of multiple doses on the 
following patient-reported 
outcomes: 
 The 11-point Numerical 
Rating Scale (NRS) 
spasticity score 
 Daily spasm count 
 The MS Spasticity Scale 
(MSSS-88) total and 
subdomain scores 
x Average 11-point NRS spasticity score over the 
last 7 days of each double-blind treatment period 
x Average daily spasm count over the last 7 days of 
each double-blind treatment period 
x Total and subdomain scores of the MSSS-88 at 
the end of the maintenance-dose phase of each 
double-blind treatment period 
Primary Estimand: the mean treatment difference (nabiximols í placebo) in the change 
in Lower Limb Muscle Tone-6 (LLMT-6) from Day 1 (predose) to Day 21 and from Day 
31 (predose) to Day 51 for all randomized patients. 
 


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Clinical Protocol Template (Phase 2–4) 
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3 
BACKGROUND AND RATIONALE 
3.1 
Disease 
Multiple sclerosis is a progressive, chronic, immune-mediated disease of the central nervous 
system1,2, diagnosed predominantly in young adults, with more than 2.3 million people 
affected worldwide3. It is the most common neurological disease in young and middle-aged 
adults, resulting in marked physical disability, inability to work or early retirement, 
significantly impaired quality of life (QoL), and a substantial burden on society in terms of 
associated costs as the disease evolves4,5. Multiple sclerosis is clinically characterized by a 
broad range of signs and symptoms, the most common being restricted mobility, spasticity, 
fatigue, sensory deficits, weakness, pain, bladder dysfunction, cognitive dysfunction, and 
visual impairment6,7. 
The pathology of MS is characterized by autoimmune damage of neuronal axons and 
destruction of the protective myelin sheath (demyelination). Several signs and symptoms may 
occur as a consequence of the nerve damage; muscle spasticity (a velocity-dependent increase 
in muscle tone resulting from an upper motor neuron lesion) is one of the most common 
manifestations of MS, affecting more than 80% of patients with MS during the course of the 
disease6,8,9. Multiple sclerosis spasticity clinically manifests as symptoms, such as muscle 
stiffness or tightness, and signs including increased tendon reflexes, clonus, and flexor and 
extensor spasms mainly in the extensor muscles of the lower limbs and flexor muscles of the 
upper limbs. On a daily basis, severity may be exacerbated by a range of concurrent medical 
conditions, such as urinary infections. The QoL of patients with MS worsens as spasticity 
severity increases5,10,11. 
The most important goals in the treatment of patients with MS-induced spasticity are to avoid 
or eliminate triggers that may elicit spasms or enhance spasticity, to reduce pain and 
symptoms of spasticity, to improve or maintain functional abilities and QoL, and to facilitate 
nursing. If physiotherapy, as a generally accepted first basic treatment option, is not 
sufficient, antispasticity medications should be tried12. Depending on the severity of 
generalized spasticity, drug treatment varies widely, reliant on approved drugs that may differ 
between geographical regions. Commonly used medications such as baclofen, tizanidine, or 
dantrolene are taken orally. Their mode of action varies, but all cause muscle relaxation. 
Both incidence and severity of MS spasticity increase as the disease evolves, appearing in 
more than 80% of patients with MS and reaching a moderate or severe intensity in over a 
third of cases despite available treatments6,13,14. Multiple sclerosis spasticity of at least 
moderate severity is present in approximately a third of patients with a 10-year history of the 
disease14. 


Study Code: GWSP20105 
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Clinical Protocol Template (Phase 2–4) 
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3.2 
Nabiximols Background 
The investigational medicinal product (IMP) nabiximols (named Sativex® in Canada, Spain, 
and the United Kingdom and also named Sativex oromucosal spray; United States [US] 
Adopted Name: Nabiximols; World Health Organization Anatomical Therapeutic Chemical 
Code: N02BG10) is formulated from 2 genetically distinct varieties of the Cannabis sativa L. 
plant, which are defined by their chemical profiles (chemotypes). GW Pharma Ltd (GW) 
produces chemotypes of Cannabis sativa L. that contain principally 1 of the 2 major 
FDQQDELQRLGVǻ9-tetrahydrocannabinol (THC) or cannabidiol (CBD). Production under 
controlled conditions ensures consistency in the starting materials. Dried plant material is 
extracted and further processed to yield the THC botanical drug substance (BDS) and CBD 
BDS. The extracts also contain smaller amounts of minor cannabinoids and the 
non-cannabinoid plant components including alpha- and trans-caryophyllenes, other terpenes, 
sterols, and triglycerides. 
Nabiximols contains amounts of both THC BDS and CBD BDS to yield similar 
concentrations of THC and CBD, dissolved in the excipients ethanol and propylene glycol, 
and delivered as an oromucosal spray. Peppermint oil is used in the spray preparation as a 
flavoring agent to mask the taste and odor of plant-based components present in the product. 
The oromucosal spray is administered under the tongue or inside the cheeks and delivers 
2.7 mg THC and 2.5 mg CBD per 100 ȝ/ spray. 
For more information, refer to the Investigator’s Brochure (IB)15. 
3.3 
Rationale 
The efficacy of nabiximols in the symptomatic treatment of spasticity associated with MS 
was originally demonstrated in trials with a primary endpoint based on a patient-reported 
outcome measure, the 11-point NRS for spasticity. Data indicating efficacy of nabiximols on 
objective measures of spasticity was limited to change in the MAS, which formed the basis 
for secondary endpoints in the SAVANT trial and in an investigator-initiated trial16. Trial 
GWSP20105 is being conducted to further evaluate the potential effect of nabiximols on 
clinical measures of velocity-dependent muscle tone, which may be considered more 
objective, and more proximate to the pathophysiology of spasticity in patients with MS than 
the 11-point NRS for spasticity. This trial may support the authorization of nabiximols for the 
symptomatic treatment of spasticity in additional markets where nabiximols is not currently 
authorized. 
3.4 
Clinical Hypothesis 
The primary clinical hypothesis is that after administration of multiple doses, there will be a 
difference between nabiximols and placebo for change in velocity-dependent muscle tone in 


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the lower limbs as measured by the Lower Limb Muscle Tone-6 (LLMT-6) from predose to 
end of treatment of each treatment period. 


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4 
EXPERIMENTAL PLAN 
4.1 
Trial Design 
This multicenter, randomized, double-blind, placebo-controlled, 2-treatment, 2-period, 
Phase 3 crossover trial is being conducted to evaluate the effect of multiple doses of 
nabiximols on clinical measures in the symptomatic treatment of patients with MS. 
Patients with spasticity associated with MS will participate in a screening period of up to 28 
days; no changes in the dosing regimen of the patients’ current MS antispasticity 
medications, if any, will be made during this period. 
As part of the baseline period of each treatment period, patients will keep an electronic diary 
to record 11-point NRS spasticity score, spasm count, and use of antispasticity medications 
once daily, around the same time each day, preferably in the evening before retiring to sleep, 
for at least 7 days prior to Visits 2 and 6. At Visit 2, in the morning of Day 1, eligible patients 
will be randomly assigned in a 1:1 ratio to 1 of 2 treatment sequences, each composed of 
2 treatment periods, with administration of multiple doses of nabiximols or placebo. 
Patients randomized will complete 2 treatment periods with administration of IMP for 
21 days per treatment period. Each treatment period will consist of a dose-titration phase of 
approximately 14 days, followed by a maintenance-dose phase of approximately 7 days, 
where the individually determined optimized dose level remains unchanged for the remainder 
of each treatment period after titration. Doses greater than 1 spray/day will be divided into a 
morning dose and an evening dose. 
Throughout both treatment periods, patients will initiate IMP treatment as a single spray in 
the clinic in the morning of Visits 2 (Day 1) and 6 (Day 31) of each treatment period. Patients 
will gradually titrate their daily dose by 1 to 2 additional sprays/day to an optimized dose or 
to a maximum of 12 sprays/day over the first approximately 14 days of treatment with an 
approximately 15-minute interval between sprays. Patients should complete titration within 
approximately 14 days of their first dose of IMP in each treatment period and should continue 
at the same dose level achieved at the end of the titration phase (i.e., their daily optimized 
dose) ±1 spray divided into a morning dose and an evening dose for the remainder of the 
treatment period. Once a stable daily dose has been reached, patients should gradually 
decrease the interval between sprays to a target interval of approximately 1 minute between 
sprays. Patients will be advised to administer IMP at approximately the same time each day 
in a consistent manner in relation to food consumption. Morning and evening doses should be 
administered around the same time within 30 minutes after starting a snack or meal. 
On the days of scheduled MAS assessments other than Visit 1 (i.e., Visits 2, 5, 6, and 9), 
patients will attend the trial site without having administered any IMP in the morning. On 
days of MAS assessment, patients who are taking antispasticity therapy should take their 
regular morning dose at least 1 hour before the administration of IMP. Administration of the 


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morning dose of IMP with a standardized snack containing at least 300 kcal (of which 
approximately 30 kcal is composed of fat) will occur at the trial site under the supervision of 
site staff; MAS assessments will occur at scheduled time points before (Visits 2 and 6 
[predose]) and after (Visits 2, 5, 6, and 9 [3 hours ±15 minutes postdose]) IMP 
administration. 
A washout period of at least 7 days will separate the 2 treatment periods. During the washout 
period, patients will continue to take their current MS antispasticity medications, if any, 
without any changes in dosing regimen. 
Patients who complete the 2 treatment periods will complete an End of Treatment Visit (Visit 
9). Patients who discontinue IMP early will be encouraged to remain in the study for the 
duration of the treatment period in which they discontinue IMP and will complete an End of 
Treatment Visit (Visit 9) at the end of that period. A Safety Follow-up Visit (Visit 10) will 
occur 7 (+ 3) days after the last dose of IMP or after the End of Treatment visit (Visit 9), 
whichever is later, for all patients. 
A schematic (Figure 1-1), presented at the end of Section 1, depicts the overall trial design. 
More detailed information on treatment and trial procedures is provided in Section 8 and 
Section 9, respectively. 
4.2 
Number of Sites 
Approximately 30 sites are expected to participate in this trial. 
4.3 
Number of Patients 
Ninety-five patients will be randomly assigned to each treatment sequence (nabiximols 
followed by placebo or placebo followed by nabiximols) to ensure that at least 170 patients in 
total complete the 2 treatment periods. If more than 20 patients withdraw from the study, 
additional patients will be enrolled to have at least 170 completers. 


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5 
INVESTIGATIONAL MEDICINAL PRODUCT 
Please refer to the separate pharmacy manual for more detailed information on the IMP. 
5.1 
Nabiximols 
Product code: GW-1000-02 
Nabiximols is presented as an oromucosal spray containing THC (27 mg/mL):CBD 
(25 mg/mL) as well as other non-cannabinoid plant components, dissolved in 
ethanol:propylene glycol (50% v/v) excipients with peppermint oil (0.05% v/v) flavoring. 
Each spray delivers 100 ȝ/RIQDEL[LPROV. 
5.2 
Placebo 
Placebo to match nabiximols is presented as an oromucosal spray containing the excipients 
ethanol and propylene glycol (50% v/v) with colorings (FD&C Yellow No.5 [0.0260% v/v], 
FD&C Yellow No.6 [0.0038% v/v], FD&C Red No.40 [0.0033% v/v], and FD&C Blue No.1 
[0.00058% v/v]) and flavored with peppermint oil (0.05% v/v). (DFKVSUD\GHOLYHUVȝ/
containing no active ingredients. 
5.3 
Packaging, Storage, and Drug Accountability 
5.3.1 
Packaging and Labeling 
The IMP will be manufactured, packaged, labeled, and/or distributed by GW or delegated 
contractors. The IMP will be presented as an oromucosal spray in a plastic-coated, amber 
glass vial. The IMP will be dispensed at each relevant visit. 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, will permit full traceability of manufacture, 
pack, and label activities conducted at or on behalf of GW and the IMP information held on 
the interactive response technology (IRT). GW will ensure that all IMP provided is fully 
labeled and packaged. 
Label text will include the following information, as a minimum: 
x Sponsor’s name and address 
x Product identification (e.g., “Nabiximols or Placebo”) 
x Product details 
x Dose and potency 
x Vial number 
x Batch number 
x Trial code 
x Site details 


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x Expiry date 
x Storage conditions 
x Instruction: “For clinical trial use only” 
x Instruction: “Keep out of the sight and reach of children” 
x Any other information required by local regulatory authorities 
In addition, any local country requirements in accordance with local drug law or regulatory 
requirement will be included in the final label text. 
Directions for use and the name, address, and telephone number of the investigator (of the 
main contact for information about the product or the clinical trial) will be provided 
separately to the patient. 
5.3.2 
Storage 
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 trial site storage location must be maintained (recording a minimum of Monday 
through Friday, excluding public holidays) from the date of receipt of first shipment until the 
end of the trial dispensing period at each site. These records must contain at least the 
minimum and maximum daily temperatures and must be made available to the appropriate 
GW personnel for review throughout the trial. Temperature during transit of IMP to the site 
must be checked on receipt and compliance/noncompliance to the minimum and maximum 
recorded. 
Should storage conditions deviate from these specified requirements, the GW trial monitor 
must be contacted immediately to confirm if the IMP remains suitable for use. The IMP must 
be placed under quarantine until written confirmation is received that the IMP is suitable for 
use. 
Patients should be instructed to store IMP in a refrigerator (2ºC to 8ºC). Once the spray 
container is opened and in use, refrigerated storage is not necessary, but the IMP should not 
be stored above 25ºC. The spray container should be stored upright. Patients will be provided 
with instructions regarding home storage requirements for the IMP. 
5.3.3 
Supply and Return of Investigational Medicinal Product 
The IMP will be transported to approved country depots and trial sites in compliance with 
good distribution practice guidelines. All IMP will be shipped with a product release 
certificate that includes a physical description of the product for confirmation of identity on 
receipt. 
Once a site has been activated via the IRT at trial initiation, IMP will be shipped to the 
identified responsible person, such as the pharmacist, at the investigator’s site, who will 


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check the amount received (against the IRT Shipment Request) and condition of the drug 
(i.e., integrity, physical appearance, and temperature during transit). Details of the IMP 
received will be recorded in the IMP accountability record (see Section 5.3.4). The site will 
acknowledge the IMP receipt via the IRT and will complete any receipt forms required. The 
IMP will be dispensed and returned as detailed in Section 8.5 with further IMP shipments to 
be initiated by IRT. As directed, all supplies, including unused, partially used, or empty 
containers, will be returned to GW/depot. 
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 must contain the 
following: 
x Trial code 
x Batch number/packaging reference number, date of receipt, and quantity of IMP 
received 
x Patient’s trial identification number 
x Date and quantity of IMP dispensed 
x The initials of the dispensing/dosing party 
x Date and quantity of IMP returned to the investigator 
x IMP expiry dates 
The IMP will be dispensed at Visits 2, 4, 6, and 8. Patients will be asked to return all IMP 
(used and unused) at each subsequent visit (Visits 4, 5, 8, and 9). The trial site will check the 
returned IMP against the usage recorded in the electronic diary. Any discrepancies will be 
discussed with the patient 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 unaccounted IMP. 
A record of returned IMP must be completed and included in the shipment of used and 
unused IMP to the relevant drug distribution depot. At the end of the trial, 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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5.3.5 
Post-trial Provision 
There will be no post-trial provision of nabiximols. 
A summary of the results of this trial will be made available on http://www.clinicaltrials.gov 
as required by US law and on http://www.clinicaltrialsregister.eu/ of the European Union 
(EU) Clinical Trials Register. 


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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, race, 
and sex; as allowed per local regulations) and outcome of screening. 
6.1 
Inclusion Criteria 
Screening (Visit 1) 
For inclusion in the trial, patients must fulfill ALL of the following criteria: 
6.1.1 Male or female, aged 18 years or above. 
6.1.2 Willing and able to give informed consent for participation in the trial (see 
Section 15.2). 
6.1.3 Willing and able (in the investigator’s opinion) to comply with all trial 
requirements. 
6.1.4 Has had a diagnosis with any disease subtype of MS, by revised 2017 McDonald 
criteria, for at least 12 months prior to Visit 1 and is expected to remain stable for 
the duration of the trial. 
6.1.5 Has an MAS untransformed score of at least 2 in 2 or more of 6 muscle groups 
(right knee flexors, left knee flexors, right knee extensors, left knee extensors, 
right plantar flexors, or left plantar flexors) at Visit 1. 
6.1.6 If currently receiving approved anti-spasticity therapy, it must be with a stable 
dosing regimen for at least 30 days prior to Visit 1. The patient must be willing to 
maintain the same antispasticity medication and not plan to initiate a new course 
of physiotherapy for the duration of the trial. 
6.1.7 If currently receiving an approved MS disease-modifying therapy, it must be at a 
stable dose for at least 3 months prior to Visit 1 and is expected to remain stable 
for the duration of the trial.  
6.1.8 If currently receiving dalfampridine or fampridine, it must be at a stable dose for 
at least 3 months prior to Visit 1 and is expected to remain stable for the duration 
of the trial. 
6.1.9 Willing to allow the responsible authorities to be notified of participation in the 
trial, if mandated by local law. 
6.1.10 Willing to allow his or her primary care practitioner (if he or she has one) and/or 
treating neurologist (if he or she has one) to be notified of participation in the trial, 
if the primary care practitioner/treating neurologist is different from the 
investigator. 


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Additional Inclusion Criteria at Randomization (Visit 2) 
Patients are eligible for randomization in the trial if, in addition to continuing to meet the 
Screening (Visit 1) inclusion criteria, they also meet the following criterion prior to Visit 2 
(Day 1): 
6.1.11 Completed at least 5 of 7 days of their electronic diary reporting during the 7 days 
immediately preceding Visit 2 (Day 1). 
6.2 
Exclusion Criteria 
The patient may not enter the trial if ANY of the following apply: 
6.2.1 Has taken nabiximols, cannabis, or a cannabis-derived product for medicinal or 
recreational purposes in the 30 days prior to Visit 1 or unable to abstain for the 
duration of the study. 
6.2.2 Did not tolerate or did not respond adequately to treatment with nabiximols or 
another cannabis-based medication if exposed at any time before the 30-day 
period prior to Visit 1. 
6.2.3 Any concomitant disease or disorder that has spasticity-like symptoms or that may 
influence the patient’s level of spasticity. 
6.2.4 Medical history suggests that relapse/remission is likely to occur during the trial, 
which, in the opinion of the investigator, is expected to influence the patient’s 
spasticity. 
6.2.5 Has had a relapse of MS within the 60 days prior to Visit 1. 
6.2.6 Currently using botulinum toxin injection for the relief of spasticity (within 
6 months of Visit 1) or is unwilling to abstain for the duration of the trial. 
6.2.7 Currently taking antipsychotic medication. 
6.2.8 Currently taking benzodiazepines unless doses and dosing regimen have been 
stable for at least 30 days prior to Visit 1. 
6.2.9 Clinically suspected to have a contracture in one of the muscle groups of the lower 
limbs, preventing assessment with the MAS. 
6.2.10 Has any known or suspected hypersensitivity to cannabinoids or any of the 
excipients of the IMP. 
6.2.11 Has experienced myocardial infarction or clinically significant cardiac 
dysfunction within the last 12 months prior to Visit 1 or has a cardiac disorder 
that, in the opinion of the investigator, would put the patient at risk of a clinically 
significant arrhythmia or myocardial infarction. 
6.2.12 Has a diastolic blood pressure of < 50 mmHg or > 105 mmHg or systolic blood 
pressure < 90 mmHg or > 150 mmHg (when measured in a sitting position at rest 


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for 5 minutes) or a postural drop in the systolic blood pressure of > 20 mmHg at 
Visit 1 or Visit 2. All measurements will be performed singly and can be repeated 
once, if any are outside the reference range but not considered clinically 
significant. 
6.2.13 Has clinically significant impaired renal function at Visit 1, as evidenced by an 
estimated creatinine clearance lower than 50 mL/min. All measurements will be 
performed singly and can be repeated once, if any are outside the reference range 
but not considered clinically significant. 
6.2.14 Has moderately impaired hepatic function at Visit 1, defined as serum alanine 
aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × upper limit of 
normal (ULN). All measurements will be performed singly and can be repeated 
once, if any are outside the reference range but not considered clinically 
significant. 
6.2.15 Male and fertile (i.e., after puberty unless permanently sterile by bilateral 
orchiectomy) unless willing to ensure that he uses male contraception (condom or 
vasectomy) or remains sexually abstinent during the trial and for 3 months 
thereafter. 
6.2.16 Female and of childbearing potential (i.e., following menarche and until becoming 
SRVWPHQRSDXVDOIRUFRQVHFXWLYHPRQWKVXQOHVVSHUPDQHQWO\VWHULOHE\
hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) unless willing 
to ensure that she uses a highly effective method of birth control (e.g., intrauterine 
device/hormone-releasing system, bilateral tubal occlusion, vasectomized partner, 
or sexual abstinence) during the trial and for 3 months thereafter. Patients using 
combined hormonal methods or a progestogen-only pill or injection or implant 
should use an additional barrier method such as a condom or diaphragm during 
the trial and for 3 months thereafter (see Section 9.2.2). 
6.2.17 Female and pregnant (positive pregnancy test at Visit 1 or Visit 2), lactating, or 
planning pregnancy during the course of the trial or within 3 months thereafter. 
6.2.18 Has received an IMP within the 30 days prior to Visit 1. 
6.2.19 Has any other clinically significant disease or disorder (including seizure disorder) 
that, in the opinion of the investigator, may put the patient, other patients, or site 
staff at risk because of participation in the trial, may influence the interpretation of 
trial results, or may affect the patient’s ability to take part in the trial. 
6.2.20 Has any abnormalities identified following a physical examination, clinical 
laboratory, serology, or other applicable screening procedures that, in the opinion 
of the investigator, would jeopardize the safety of the patient or the conduct of the 
study if he or she took part in the trial. 


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6.2.21 Has any history of suicidal behavior in the 5 years prior to Visit 1 or a score of 3, 
4, or 5 on the C-SSRS in the month prior to Visit 1. 
6.2.22 Has donated blood during the 3 months prior to Visit 1 and is unwilling to abstain 
from donation of blood during the trial. 
6.2.23 Has been previously randomized into this trial. 
6.2.24 Has any known or suspected history of alcohol or substance abuse (including 
opiate abuse) or dependence within 1 year prior to Visit 1. 
6.2.25 Currently using an illicit drug or current nonprescribed use of any prescription 
drug. 
6.2.26 Has a history of psychiatric or neurologic disorder that, in the opinion of the 
investigator, may interfere with trial participation, data interpretation, or conduct 
of trial procedures. 
6.2.27 Has a history of severe psychiatric disorder that may be exacerbated by the use of 
a cannabinoid-containing product. 
6.2.28 Has any planned clinical interventions or intends to change any or all medications 
that may have an effect on spasticity or MS during the trial. 
6.2.29 Currently taking drugs that are solely metabolized by UGT1A9 and UGT2B7 (see 
Appendix 4). 
6.2.30 Currently taking strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, 
phenytoin, phenobarbital, St John's Wort). 


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7 
PATIENT ENROLLMENT 
Before patients may be entered into the trial, GW requires a copy of the relevant site’s 
institutional review board (IRB) or independent ethics committee (IEC) written approval of 
the protocol, informed consent form (ICF), and other patient information material. Patients 
will be considered enrolled in the trial from the time of providing written informed consent. 
All patients must personally sign and date the consent form prior to any procedures being 
performed (refer to Section 9.2.1 and Section 15.2). 
7.1 
Treatment Assignment 
At the start of Visit 1, enrolled patients will be allocated a unique patient number in a 
sequential order by trial site. Following randomization, GW will provide all IMP in a packed 
and labeled state, and the IRT will identify the pack number to be dispensed to the patient at 
each relevant visit according to the treatment sequence assigned in the randomization 
schedule. 
7.2 
Randomization 
The allocation of IMP to treatment number will be done according to a randomization 
schedule produced by an independent statistician. The randomization schedule will be held 
centrally on the IRT and not divulged to any other person involved in the trial until the 
database has been locked and unblinding authorized by the relevant GW personnel. For 
access to blinded treatment assignment, see Section 8.6. If more than 20 patients withdraw 
from the study, additional patients will be enrolled to have at least 170 completers. 


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8 
TREATMENT PROCEDURES 
8.1 
Investigational Medicinal Product Dosage, Administration, and 
Schedule 
The IMP will be presented as a pump oromucosal spray. Nabiximols oromucosal spray is a 
mixture of THC and CBD extracts derived from Cannabis sativa L. Each of the botanical 
extracts contains a cannabinoid as the major constituent (i.e., THC or CBD) and minor 
constituents, including other cannabinoid and noncannabinoid plant components, including 
alpha- and trans-caryohyllenes, other terpenes, sterols, and triglycerides. 
The use of placebo in the current trial is deemed necessary to determine the efficacy or safety 
of the current intervention(s), since the best proven intervention has already been tried/is 
being given as background treatment and has failed to/does not fully alleviate the patient’s 
symptoms. Placebo to match nabiximols is presented as an oromucosal spray containing 
excipients, coloring, and flavoring, with no active ingredients. 
For details regarding IMP formulations, see Section 5. 
8.1.1 
Dose Administration 
For all treatment sequences, IMP will be administered by the patient via a pump actuation of 
oromucosal spray. The IMP will be self-administered to the oral mucosa. Patients will receive 
IMP dosing training from site staff on Visit 2 (Day 1 predose). Patients will be advised to 
administer IMP at approximately the same time each day in a consistent manner in relation to 
food consumption. Morning and evening doses should be administered around the same time 
within 30 minutes after starting a snack or meal. Patients should divide doses greater than 
1 spray/day into a morning dose and an evening dose. On the days of scheduled MAS 
assessments other than Visit 1 (i.e., Visits 2, 5, 6, and 9), patients will attend the trial site 
without having administered any IMP in the morning. On the days of MAS assessment, 
patients who are taking antispasticity therapy should take their regular morning dose at least 
1 hour before the administration of IMP. Administration of the morning dose of IMP with a 
standardized snack containing at least 300 kcal (of which approximately 30 kcal is composed 
of fat) will occur at the trial site under the supervision of site staff. 
Following the titration phase (see Section 8.1.2), IMP will be administered as 1 spray 
(100 ȝ/ per spray) with a target interval of approximately 1 minute, until the patient’s 
specific optimized dose has been administered. Patients should be advised to direct each 
spray at a different site on the oromucosal surface, changing the application site for each 
spray of the IMP. If lesions are observed or persistent soreness is reported, the IMP 
administration must be interrupted until complete resolution occurs. Events of this nature are 
to be recorded according to the adverse event (AE) procedures (see Section 12). 


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8.1.2 
Dose Escalation and Dose Adjustments 
Site staff will demonstrate proper dosing and then observe dosing by the patient at Visit 2 
(Day 1) and verify that IMP was correctly administered. Patients will initiate IMP treatment 
as a single spray in the clinic in the morning of Visits 2 (Day 1) and 6 (Day 31) of each 
treatment period. Patients will gradually titrate their daily dose to the maximally acceptable 
dose, balancing efficacy and tolerability, or to a maximum number of 12 sprays/day. During 
the titration phase, there should be an approximately 15-minute interval between sprays. 
Patients may temporarily pause or slightly reduce the number of sprays upon the emergence 
of AEs; the titration may be resumed when the AEs resolve. No further dose adjustments 
should take place after 14 days unless advised by the investigator. An example titration 
schedule is presented in Table 8.1.2-1. 
Patients should not take more than 12 sprays/day of IMP at any time during the trial. Patients 
should consult the dosing instructions provided and contact the investigational site when in 
doubt about changes in the daily dose of IMP at any time during the study. 
Table 8.1.2-1 
Example Titration Schedule 
Day 
Number of Sprays in the 
Morning 
Number of Sprays in the 
Evening 
Total Number of 
Sprays/Day 
1 
1 
0 
1 
2 
1 
1 
2 
3 
1 
2 
3 
4 
2 
2 
4 
5 
3 
2 
5 
6 
3 
3 
6 
7 
4 
3 
7 
8 
4 
4 
8 
9 
5 
4 
9 
10 
5 
5 
10 
11 
6 
5 
11 
12 
6 
6 
12 
13 
6 
6 
12 
14 
6 
6 
12 
Patients should complete titration within approximately 14 days of their first dose of IMP in 
each treatment period and should continue at the same dose level achieved at the end of the 
titration phase (i.e., their daily optimized dose) ±1 spray /day divided into a morning dose and 
an evening dose for the remainder of the treatment period. This guidance applies unless 
patients agree with the investigator to lower the dose of IMP to address poor tolerability. 
Once a stable daily dose has been reached, patients should gradually decrease the interval 
between sprays to a target interval of approximately 1 minute between sprays. 
The total daily dose should be administered as a morning dose and an evening dose, which 
may be comprised of a different number of sprays during titration. During the period of stable 
dosing following titration, patients should attempt to achieve a balance in the number of 
sprays administered as part of the morning and evening doses of IMP. 


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8.2 
Washout Period 
Following the final dose of IMP in Treatment Period 1, in the morning of Visit 5 (Day 21), 
patients will discontinue treatment with IMP for at least 7 days prior to Visit 6 (Day 31). This 
represents the washout period between the 2 treatment periods of this crossover trial. 
8.3 
Concomitant Therapy 
From Screening (Visit 1) forward, any new treatments taken or any change to ongoing 
medications during the patient’s participation in the trial will be recorded on the appropriate 
electronic case report form (eCRF) page by the investigator or designee. Similarly, any 
ongoing physiotherapy as part of the management of spasticity at the time of enrollment will 
be documented on a separate eCRF page as well as any changes in physiotherapy regimen 
that occur in the course of the study (e.g., discharge from physiotherapy). 
For details about the potential for interactions from initiating IMP with prior medications, 
refer to the guidance for the investigator and potential drug interactions within the IB15. 
8.3.1 
Concomitant Antispasticity Medications 
As nabiximols is being investigated as therapy in patients with spasticity due to MS, patients 
may currently be taking oral antispasticity medication. If currently receiving approved 
anti-spasticity therapy, the antispasticity medication must have been stable for at least 30 
days prior to Screening (Visit 1) and the medication is expected to remain stable throughout 
the duration of the trial. The patient must be willing to maintain the same antispasticity 
therapy and not plan to initiate a new course of physiotherapy for the duration of the trial. 
Benzodiazepines use is allowed if doses and dosing regimen have been stable for at least 30 
days prior to Visit 1. 
If the patient is currently receiving an approved MS disease-modifying therapy or 
dalfampridine or fampridine, it must be at a stable dose for at least 3 months prior to Visit 1 
and is expected to remain stable for the duration of the trial. 
8.4 
Prohibited Therapy During Trial Period 
The following medications are prohibited for the duration of the trial: 
x Cannabis use for medical or recreational purposes or any cannabinoid-based 
medication within 30 days of Visit 1 and for the duration of the trial 
x Botulinum toxin injection for the relief of spasticity within 6 months of Visit 1 and for 
the duration of the trial 
x Antipsychotic medication 
x Any benzodiazepines use on an as-needed (PRN) basis 
x Drugs that are solely metabolized by UGT1A9 and UGT2B7 (see Appendix 4). 


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x Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital, 
St John's Wort) 
Any patients taking these medications after Visit 1 may be considered for withdrawal from 
IMP. 
8.5 
Compliance in Investigational Medicinal Product Administration 
The patient will record the number of sprays administered on each treatment day in the 
electronic diary. 
Patients should return all IMP (used and unused) at each of Visits 4, 5, 8, and 9. The 
electronic diary-reported dosing information and any discrepancies discussed with the patient 
at the time of the visit will be checked and documented accordingly within the patient’s 
source documents. 
Records of IMP accountability will be maintained according to Section 5.3.4. 
8.6 
Access to Blinded Treatment Assignment 
The identity of IMP assigned to patients will be held by the IRT. The principal investigator 
(PI) at each site, or his or her designee, is responsible for ensuring that information on how to 
access the IRT 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 IMP will not be dependent on 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, he or she must contact GW within 1 working day of the 
event and must document the time, date, and reason(s) for unblinding in the patient’s medical 
notes and on the eCRF. 


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9 
TRIAL PROCEDURES 
A list of the required trial 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 on the eCRF. 
Additional procedures to screen for the presence of or immunity against infectious diseases 
(such as body temperature, sampling of nasal or pharyngeal mucosa or serology) may be 
conducted at screening, at the beginning of each visit or as needed, according to local 
guidance and policy; for further details, see Section 9.2.19. 
The location of the source data for the following procedures will be documented, per site, in a 
signed source data verification plan; for further details, see Section 16.2. 
In cases where patients are not able to attend study visits due to the presence of an infectious 
disease or other transmissible condition, the investigator will discuss with the Sponsor 
potential mitigation approaches (including but not limited to extending the visit window, 
conducting evaluations via video link or phone call, allowing for safety procedures to be 
conducted at the patient’s home or local facility, or implementing potential mitigation 
approaches for IMP dispensing, secure delivery, and collection). The rationale (e.g., the 
specific limitation imposed by the infectious disease that led to the inability to perform the 
protocol-specified assessment) and outcome of the discussion will be documented in the 
medical record. 
9.1 
Trial Procedures by Visit 
Patients will be invited to take part in the trial and will be issued with the patient information 
and informed consent. Following adequate time to discuss the trial with the investigator, 
nurse, relatives, or caregiver, as wished, patients who provide written informed consent will 
be screened for entry into the trial. 
9.1.1 
Screening (Visit 1 [Days -28 to -1]) 
Informed consent (see Section 9.2.1) must be obtained from the patient prior to beginning any 
trial-related procedures. 
The following assessments/procedures will be performed: 
x Eligibility check (Section 6) 
x Demographics (Section 9.2.3) 
x Previous cannabis use (Section 9.2.4) 
x Medical history (Section 9.2.5) 
x Electronic diary training (Section 9.2.14.1) 
x Concomitant medications review (Section 9.2.6) 


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x AE review (Section 9.2.17) 
x Physical examination (including height measurement; Section 9.2.7) 
x Oral mucosa examination (Section 9.2.8) 
x Body weight measurement (Section 9.2.9) 
x Vital signs measurement (Section 9.2.10) 
x 12-lead ECG (Section 9.2.11) 
x Clinical laboratory blood sampling (hematology and biochemistry) (Section 9.2.12) 
x Dipstick urinalysis (Section 9.2.12) 
x Urine drug screen (including THC) (Section 9.2.12) 
x Serum pregnancy test (if appropriate) (Sections 9.2.2 and 9.2.12) 
x Blood THC test (Section 9.2.12) 
x MAS assessment (Section 9.2.15.1) 
x C-SSRS assessment (Section 9.2.15.3) 
The investigator should review the laboratory results as soon as these become available. If the 
results show that a patient is ineligible, the patient will fail screening. 
Following Visit 1, there will be no changes in the dosing regimen of the patient’s current oral 
MS antispasticity medications (if any). 
Patients who satisfy all of the inclusion criteria and none of the exclusion criteria specified in 
Section 6 will enter a baseline period of at least 7 days prior to Visit 2, during which they will 
be required to take their oral antispasticity medication (if any) and complete an electronic 
daily diary to record their 11-point NRS spasticity score, spasm count, and use of 
antispasticity medications once daily, around the same time each day, preferably in the 
evening before retiring to sleep. 
9.1.1.1 
Screening Failures 
Screen failures are defined as participants who consent to participate in the clinical trial but 
are not subsequently randomly assigned to trial intervention. A minimal set of screen failure 
information is required to ensure transparent reporting of individuals who failed screening in 
order to meet the Consolidated Standards of Reporting Trials publishing requirements and to 
respond to queries from regulatory authorities. The minimal information includes 
demography, screen failure details, eligibility criteria, and any serious adverse event (SAE). 
Individuals who do not meet the criteria for participation in this trial (screen failure) for 
reasons such as fever due to a brief acute upper respiratory illness, having taken a prohibited 
over-the-counter medication within the excluded period, recent blood donation, or who could 
not be enrolled within the screening window for logistical reasons, may be allowed one 
opportunity to be rescreened at the discretion of the investigator or designee. The rescreened 


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patient will be assigned a new patient number and all screening assessments will be repeated. 
Patients will not be rescreened more than once. 
9.1.2 
Treatment Period 1 (Visits 2 to 5 [Days 1 to 21]) 
This treatment period will consist of a dose-titration phase of approximately 14 days followed 
by a maintenance-dose phase of approximately 7 days, where the individually determined 
optimized dose level remains unchanged for the remainder of the treatment period after 
titration. On the days of scheduled MAS assessments other than Visit 1 (i.e., Visits 2 and 5), 
patients will attend the trial site without having administered any IMP in the morning. On the 
days of MAS assessment, patients who are taking antispasticity therapy should take their 
regular morning dose at least 1 hour before administration of IMP. Patients will continue to 
take their current oral antispasticity medications without any changes in dosing regimen. 
9.1.2.1 
Visit 2 (Day 1) 
Patients will return to the site in the morning of Day 1 when eligibility will be confirmed and 
patients will be randomized. 
The following assessments/procedures will be performed on Day 1 predose: 
x Eligibility check 
x Concomitant medications review 
x AE review 
x Examination of oral mucosa 
x Body weight measurement 
x Vital signs measurement 
x Urine drug screen (including THC) 
x Urine pregnancy test (if appropriate) 
x Randomization (Section 7.2) 
x PK blood sampling for IMP (Section 9.2.12.1) 
x MAS assessment 
x T25FW test (Section 9.2.15.4) 
x C-SSRS assessment 
x IMP dosing training (Section 9.2.14.3) 
x IMP dispensing 
Following predose assessments and after IMP dosing training and dispensing, site staff will 
observe dosing by the patient and verify that IMP was correctly administered. Patients will 
administer a single dose of IMP with a standardized snack containing at least 300 kcal (of 
which approximately 30 kcal is composed of fat) at the trial site under the supervision of site 
staff. 


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The following assessments/procedures will be performed 2 to 4 hours postdose: 
x MAS assessment (3 hours ±15 minutes postdose) 
x AE review 
x Vital signs measurement 
x PK blood sampling for IMP (Section 9.2.12.1) 
The patient will be provided dosing instructions and advised to contact the investigational site 
when in doubt about changes in the daily dose of IMP. The patient will be instructed to 
record IMP doses administered in the patient electronic diary. 
The exact time of PK blood sampling and the time of the patient’s snacks and meals should 
be recorded. 
Following Visit 2, patients will titrate their daily dose of IMP for approximately 14 days until 
they achieve an optimized dose with an approximately 15-minute interval between sprays; 
patients should divide doses greater than 1 spray/day into a morning dose and an evening 
dose. Administration of the morning and evening doses of IMP should be maintained around 
the same time each day in a consistent manner in relation to food consumption, i.e., within 
30 minutes after starting a snack or meal. 
Patients should be reminded to record their 11-point NRS spasticity score, spasm count, and 
use of antispasticity medications in the electronic diary once daily, around the same time each 
day, preferably in the evening before retiring to sleep. In addition, on the day before Visits 4 
and 5, patients will be prompted to record whether they started their morning and evening 
doses of IMP within 30 minutes of a snack or meal. 
Each site will have the option to follow-up with the patient through telephone calls during the 
titration phase to monitor the patient’s titration, safety and tolerance, and electronic daily 
diary reporting. 
9.1.2.2 
Visit 3 (Day 8, Phone Call) 
Visit 3 will occur 7 days after the first dose of IMP and will consist of a phone call from site 
staff to patients to monitor adherence with IMP administration and advise on dose titration if 
required. Concomitant medications and AEs will be collected during this call. 
9.1.2.3 
Visit 4 (Day 15) and Visit 5 (Day 21) 
Visits 4 and 5 will occur 14 and 20 days after the first dose of IMP, respectively. A visit 
window of ±1 and ±2 days, respectively, from the scheduled visit date is permitted, but it is 
preferred that the visit is performed on the scheduled visit day, where possible. 
Once a stable daily dose has been reached, patients should gradually decrease the interval 
between sprays to a target interval of approximately 1 minute between sprays. Patients should 
continue IMP administration at the same dose level achieved at the end of titration (i.e., their 


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daily optimized dose) ±1 spray divided into a morning dose and an evening dose for 
approximately 7 days (maintenance-dose phase). Administration of the morning and evening 
doses of IMP should be maintained around the same time of each day in a consistent manner 
in relation to food consumption, i.e., within 30 minutes after starting a snack or meal. 
On Visit 5, patients will administer their morning dose of IMP with a standardized snack 
containing at least 300 kcal (of which approximately 30 kcal is composed of fat) at the trial 
site under the supervision of site staff. The IMP will not be administered in the evening of 
Visit 5 (Day 21). 
The following assessments/procedures will be performed at these visits, unless otherwise 
indicated: 
x MAS assessment (Visit 5 [3 hours ±15 minutes after the first spray of the morning 
dose] only) 
x T25FW test (Visit 5 only) 
x Concomitant medications review 
x AE review 
x Physical examination (Visit 5 only) 
x Examination of the oral mucosa 
x Vital signs measurement 
x 12-lead ECG (Visit 5 only) 
x Clinical laboratory sampling (hematology and biochemistry) (Visit 5 only) 
x PK blood sampling for IMP (Section 9.2.12.1) 
x MSSS-88 assessment (Visit 5 only) 
x C-SSRS assessment 
x IMP dosing at the investigational site (Visit 5 [morning] only) 
x IMP dispensing (Visit 4 only) 
x IMP collection and compliance review (Section 9.2.16) 
The exact time of PK blood sampling and the time of the patient’s snacks and meals should 
be recorded. 
Patients should be reminded to record their 11-point NRS spasticity score, spasm count, use 
of antispasticity medications, and IMP dosing in the electronic diary once daily, around the 
same time each day, preferably in the evening before retiring to sleep. 
9.1.3 
Washout Period (Days 22 to 30) 
A washout period of at least 7 days will separate the 2 treatment periods. Following the final 
dose of IMP in Treatment Period 1, in the morning of Visit 5 (Day 21), patients will 
discontinue treatment with IMP for the 7 days prior to Visit 6 (Day 31). Patients will continue 
to take their current oral antispasticity medications without any changes in dose. Patients 


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should be reminded to record their 11-point NRS spasticity score, spasm count, and use of 
antispasticity medications in the electronic diary once daily, around the same time each day, 
preferably in the evening before retiring to sleep, for at least 7 days prior to Visit 6. 
9.1.4 
Treatment Period 2 (Visits 6 to 9 [Days 31 to 51]) 
This treatment period will consist of a dose-titration phase of approximately 14 days followed 
by a maintenance-dose phase of approximately 7 days, where the individually determined 
optimized dose level remains unchanged for the remainder of the treatment period after 
titration. On the days of scheduled MAS assessments other than Visit 1 (i.e., Visits 6 and 9), 
patients will attend the trial site without having administered any IMP in the morning. On the 
days of MAS assessment, patients who are taking antispasticity therapy should take their 
regular morning dose at least 1 hour before administration of IMP. Patients will continue to 
take their current oral antispasticity medications without any changes in dosing regimen. 
9.1.4.1 
Visit 6 (Day 31) 
Visit 6 will occur 30 days after the first dose of IMP. A visit window of ±1 day 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/procedures will be performed on Day 31 predose: 
x Concomitant medications review 
x AE review 
x Examination of oral mucosa 
x Body weight measurement 
x Vital signs measurement 
x Urine pregnancy test (if appropriate) 
x PK blood sampling for IMP (Section 9.2.12.1) 
x MAS assessment 
x T25FW test 
x C-SSRS assessment 
x IMP dispensing 
Following predose assessments and IMP dispensing, patients will administer a single dose of 
IMP with a standardized snack containing at least 300 kcal (of which approximately 30 kcal 
is composed of fat) at the trial site under the supervision of site staff. 
The following assessments/procedures will be performed 2 to 4 hours postdose: 
x MAS assessment (3 hours ±15 minutes postdose) 
x AE review 
x Vital signs measurement 


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x PK blood sampling for IMP (Section 9.2.12.1) 
The patient will be provided dosing instructions and advised to contact the investigational site 
when in doubt about changes in the daily dose of IMP. The patient will be instructed to 
record IMP doses administered in the patient electronic diary. 
The exact time of PK blood sampling and the time of the patient’s snacks and meals should 
be recorded. 
Following Visit 6, patients will titrate their daily dose of IMP for approximately 14 days until 
they achieve an optimized dose with an approximately 15-minute interval between sprays; 
patients should divide doses greater than 1 spray/day into a morning dose and an evening 
dose. Administration of the morning and evening doses of IMP should be maintained around 
the same time each day in a consistent manner in relation to food consumption, i.e., within 
30 minutes after starting a snack or meal. 
Patients should be reminded to record their 11-point NRS spasticity score, spasm count, and 
use of antispasticity medications in the electronic diary once daily, around the same time each 
day, preferably in the evening before retiring to sleep. In addition, on the day before Visits 8 
and 9, patients will be prompted to record whether they started their morning and evening 
doses of IMP within 30 minutes of a snack or meal. 
Each site will have the option to follow-up with the patient through telephone calls during the 
titration phase to monitor the patient’s titration, safety and tolerance, and electronic daily 
diary reporting. 
9.1.4.2 
Visit 7 (Day 38, Phone Call) 
Visit 7 will occur 7 days after the first dose of IMP during Period 2 and will consist of a 
phone call from site staff to patients to monitor adherence with IMP administration and 
advise on dose titration if required. Concomitant medications and AEs will be collected 
during this call. 
9.1.4.3 
Visit 8 (Day 45) and Visit 9 (Day 51, End of Treatment) 
Visits 8 and 9 will occur 44 and 50 days after the first dose of IMP, respectively. A visit 
window of ±1 and ±2 days, respectively, from the scheduled visit date is permitted, but it is 
preferred that the visit is performed on the scheduled visit day, where possible. 
Once a stable daily dose has been reached, patients should gradually decrease the interval 
between sprays to a target interval of approximately 1 minute between sprays. Patients should 
continue IMP administration at the same dose level achieved at the end of titration (i.e., their 
daily optimized dose) ±1 spray divided into a morning dose and an evening dose for 
approximately 7 days (maintenance-dose phase). Administration of the morning and evening 


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doses of IMP should be maintained around the same time of each day in a consistent manner 
in relation to food consumption, i.e., within 30 minutes after starting a snack or meal. 
On Visit 9, patients will administer the morning dose of IMP with a standardized snack 
containing at least 300 kcal (of which approximately 30 kcal is composed of fat) at the trial 
site under the supervision of site staff. The IMP will not be administered in the evening of 
Visit 9 (Day 51). 
The following assessments/procedures will be performed at these visits, unless otherwise 
indicated: 
x MAS assessment (Visit 9 [3 hours ±15 minutes after the first spray of the morning 
dose] only) 
x T25FW test (Visit 9 only) 
x Concomitant medication review 
x AE review 
x Physical examination (Visit 9 only) 
x Examination of the oral mucosa 
x Vital signs measurement 
x 12-lead ECG (Visit 9 only) 
x Clinical laboratory sampling (hematology and biochemistry) (Visit 9 only) 
x PK blood sampling for IMP (Section 9.2.12.1) 
x MSSS-88 assessment (Visit 9 only) 
x C-SSRS assessment 
x IMP dosing at the investigational site (Visit 9 [morning] only) 
x IMP dispensing (Visit 8 only) 
x IMP collection and compliance review 
The exact time of PK blood sampling and the time of the patient’s snacks and meals should 
be recorded.  
Patients should be reminded to record their 11-point NRS spasticity score, spasm count, use 
of antispasticity medications, and IMP dosing in the electronic diary once daily, around the 
same time each day, preferably in the evening before retiring to sleep. 
If the decision is made to discontinue IMP early, the patient concerned will be encouraged to 
remain in the study for the duration of the treatment period in which they discontinue IMP 
and will complete an End of Treatment Visit (Visit 9) at the end of that period. 
9.1.5 
Safety Follow-up Visit (Visit 10 [Day 58]) 
The Safety Follow-up Visit will occur 7 days after the last dose of IMP or after the 
End of Treatment visit (Visit 9), whichever is later. A visit window of + 3 days from the 


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scheduled visit date is permitted, but it is preferred that the visit is performed on the 
scheduled visit day, where possible. 
The following assessments/procedures will be performed: 
x Concomitant medication review 
x AE review 
x Examination of oral mucosa 
x Body weight measurement 
x Vital signs measurement 
x Dipstick urinalysis 
x Serum pregnancy test (if appropriate) 
x C-SSRS assessment 
9.2 
Trial Procedure Listing 
9.2.1 
Informed Consent 
Adult patients with an adequate level of understanding must personally sign and date the 
IRB/IEC-approved ICF before any trial-specific procedures are performed or any 
patient-related data are recorded for the trial. 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 Good Clinical Practice [GCP] Topic E6(R2), Section 4.8.9). 
If the patient cannot write, they can give consent by “making their mark” on the consent form 
(e.g., writing an “X”). 
The original signed ICF should be retained, and a copy should be provided to the patient. For 
further details regarding the informed consent, see Section 15.2. 
9.2.2 
Contraception Requirements 
To be eligible for the trial, female patients of childbearing potential (i.e., following menarche 
DQGXQWLOEHFRPLQJSRVWPHQRSDXVDOIRU 12 consecutive months unless permanently sterile 
by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) must have agreed that 
they are willing to use highly effective contraception for the duration of the trial and for 
3 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 


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consistently and correctly. Such methods include an intrauterine device/hormone-releasing 
system, 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 abstinence. Due to the possible interaction of 
the IMP with contraceptive steroids, the use of hormonal contraception must be 
supplemented with a barrier method (preferably male condom or diaphragm). 
To be eligible for the trial, male patients who are fertile (i.e., after puberty unless 
permanently sterile by bilateral orchiectomy) must have agreed that they are willing to use 
male contraception (condom or vasectomy) or remain sexually abstinent during the trial and 
for 3 months thereafter. 
Abstinence, as referenced above, is only acceptable as true abstinence, i.e., when this is in 
line with the preferred and usual lifestyle of the patient. Periodic abstinence (calendar, 
symptothermal, and postovulation methods), withdrawal (coitus interruptus), spermicides 
only, and the lactational amenorrhea method are not acceptable methods of contraception. 
9.2.3 
Demographics 
At screening (Visit 1), the following information will be obtained for each patient: date of 
birth, sex, and race (if allowed per local regulations). 
9.2.4 
Previous Cannabis Use 
At Screening (Visit 1), any intermittent or regular previous use of cannabis or cannabinoid 
products for medical or recreational purposes will be recorded. 
9.2.5 
Medical History 
Relevant, significant medical history will be obtained at Screening (Visit 1) and is defined as 
any condition or disease that: 
x May affect the condition under study in this trial 
x Is ongoing on entry into the trial 
x Has occurred within 1 year prior to Screening (Visit 1) 
x Suspected or confirmed COVID-19 infection (or other significant communicable 
diseases) within 1 year prior to screening 
9.2.6 
Concomitant Medication 
Details of all current medications will be recorded. Any changes in concomitant medication 
during the trial must be recorded on the eCRF at trial visits. Patients should stop taking any 
prohibited therapy prior to Screening (Visit 1), as defined in Section 8.4. 


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9.2.7 
Physical Examination 
A full physical examination will be performed at the time points specified in the Schedule of 
Assessments (see Appendix 1); height will be recorded at Screening (Visit 1) only. 
9.2.8 
Examination of Oral Mucosa 
Examination of the oral mucosa will occur at relevant visits (see Appendix 1). 
9.2.9 
Body Weight Measurements 
Body weight measurements will be recorded at relevant visits (see Appendix 1). 
9.2.10 
Vital Signs 
As part of the screening procedures at Visit 1, vital signs (systolic and diastolic blood 
pressure and pulse rate) will first be measured after the patient assumed a supine position for 
5 minutes. Vital signs will then be measured within 2 minutes of assuming a standing 
position in ambulatory patients only. At all subsequent time points, vital sign measurements 
will be completed in a sitting position at rest for 5 minutes. Blood pressure should be 
recorded using the same arm throughout the trial, where possible. 
Additional vital signs measurements may be taken during the trial if clinically indicated. 
9.2.11 
12-Lead Electrocardiogram 
A 12-lead ECG will be performed after 5 minutes in a supine position. A physician must 
review the ECG (annotated, signed, and dated) and any abnormal findings considered to 
indicate significant medical history or AEs must be recorded appropriately on the eCRF. 
Additional ECG measurements can be taken at any time during the trial, if clinically 
indicated. 
9.2.12 
Clinical Laboratory Sampling 
The investigator and trial monitor will be provided with a list of the normal ranges used by 
the central clinical laboratory for all variables assayed during the trial and a statement of 
accreditation (or similar) for the laboratory. Clinical laboratory sample parameters are 
detailed in Table 9.2.12-1. 
All clinical blood samples other than PK sampling will be analyzed at a central clinical 
laboratory. Urine samples for biochemistry will be analyzed at the trial site by use of a 
dipstick. In cases where samples cannot be analyzed at the site due to local regulations, a full 
set of urine samples should be sent to the central clinical laboratory for analysis. Urine 
sample volume requirements and processing procedures will be detailed in a separate 
laboratory manual. 


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Table 9.2.12-1 
Biochemistry, Hematology, Urinalysis, Pregnancy Test, and Drug 
Screen 
Biochemistry 
(Serum¹) 
Hematology 
(Whole Blood¹) 
Urinalysis 
(Urine²) 
Pregnancy Test 
(Serum¹/ 
Urine²) 
Drug Screen 
(Serum¹/ 
Urine3) 
Alanine aminotransferase Hematocrit 
Blood 
Serum and urine 
THC 
Albumin 
Hemoglobin 
Glucose 
 
Drugs of 
abuse 
Alkaline phosphatase 
Mean cell volume 
Nitrites 
 
 
Aspartate 
aminotransferase 
Mean corpuscular 
hemoglobin 
pH 
 
 
Calcium 
Platelets 
Protein 
 
 
Creatinine 
Red blood cell count 
White blood cells 
 
 
Gamma-glutamyl 
transferase 
White blood cell count 
with automated 
differential 
Specific gravity 
 
 
Potassium 
 
Ketones 
 
 
Sodium 
 
Urobilinogen 
 
 
Total bilirubin 
 
Bilirubin 
 
 
Total protein 
 
 
 
 
Urea (blood urea 
nitrogen) 
 
 
 
 
Prothrombin time 
(plasma4) 
 
 
 
 
THC = ǻ9-tetrahydrocannabinol. 
¹ Analyzed at a central laboratory. 
² Analyzed at the trial site by use of a dipstick (if allowed per local regulations). 
3 The standard drugs of abuse screen, including THC, will be analyzed by use of a urine dipstick at Visits 1 
and 2. Patients will undergo a separate blood THC test at Visit 1 only. 
4 Analyzed at Screening (Visit 1) only. 
All laboratory results will be reviewed, and the reports signed and dated by an investigator. 
Any results considered to be of clinical significance must be addressed and followed up as 
clinically appropriate. The results of blood THC testing at Screening (Visit 1) will be 
reported back to the trial site for confirmation of eligibility. All laboratory results considered 
to represent an AE must be documented on the eCRF. For reporting and follow-up of 
potential cases of drug-induced liver injury, see Section 12.8. 
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. 
Blood sample volume requirements and processing procedures will be detailed in a separate 
laboratory manual; the maximum amount of blood taken during the course of the trial, 
including PK blood samples, will be approximately 115 mL, taking into account possible 
repeat tests. If deemed necessary by the investigator or the sponsor, the number and/or 
volume of blood samples per assessment may be increased as long as the total volume of 
blood drawn for a subject does not surpass 500 mL (except when extra blood samples need to 
be taken for safety reasons). 


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9.2.12.1 
Pharmacokinetic Blood Sampling 
Plasma concentrations will be obtained for THC and its relevant metabolites (11-OH-THC 
and 11-COOH-THC) and CBD and its relevant metabolites (7-OH-CBD and 7-COOH-CBD) 
at distinct time points (Visits 2, 4, 5, 6, 8, and 9). The exact time of PK blood sampling and 
the time of the patient’s snacks and meals should be recorded. On the day before PK blood 
sampling at Visits 4, 5, 8, and 9, patients will be prompted to record whether they started 
their morning and evening doses of IMP within 30 minutes of a snack or meal. The PK blood 
sampling schedule is presented in Table 9.2.12.1-1. 
Table 9.2.12.1-1 
Pharmacokinetic Blood Sampling Schedule 
Visit/Day 
Time Points 
Visit 2/Day 1 
Predose and at 0-2 and 2-4 hours postdose 
Visit 4/Day 15 
0-2 and 2-4 hours postdose 
Visit 5/Day 21 
Predose and at 0-1 and 2-3 hours postdose 
Visit 6/Day 31 
Predose and at 0-2 and 2-4 hours postdose 
Visit 8/Day 45 
0-2 and 2-4 hours postdose 
Visit 9/Day 51 
Predose and at 0-1 and 2-3 hours postdose 
Analysis of all PK samples will be conducted at a central bioanalytical laboratory. Blood 
sample volume requirements and processing procedures will also be detailed in a separate 
laboratory manual; the maximum amount of blood taken for PK analyses during the course of 
the trial will be approximately 75 mL, taking into account possible repeat tests. The patient 
must be advised that it may not be safe for the patient to undertake further blood tests within 
1 month of any trial-related blood draws and to inform the investigator if they suffered any 
blood loss during the 1-month period leading up to a planned blood draw. 
9.2.13 
Interactive Response Technology 
The IRT will be used to assign patients to treatment sequences, manage IMP supply, and to 
provide treatment allocation information in the event of patient unblinding. 
A member of the trial team must contact the IRT at each clinic visit in order to perform the 
following: 
x Randomize a patient (Visit 2) 
x Obtain IMP dispensing information (Visits 2, 4, 6, and 8) 
x Provide completion/early withdrawal information (Visit 9) 
Training will be given to all sites prior to the start of the trial. 
9.2.14 
Electronic Patient Diary 
As part of the baseline period of each treatment period, patients will record their 11-point 
NRS spasticity score, spasm count, and use of antispasticity medications in the electronic 


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diary once daily, around the same time each day, preferably in the evening before retiring to 
sleep, for at least 7 days prior to Visits 2 and 6. 
Throughout the trial, the patient will complete an electronic diary once daily, around the same 
time each day, preferably in the evening before retiring to sleep, to record 11-point NRS 
spasticity score, spasm count, use of antispasticity medications, and IMP dosing. In addition, 
on the day before PK blood sampling at Visits 4, 5, 8, and 9, patients will be prompted to 
record whether they started their morning and evening doses of IMP within 30 minutes of a 
snack or meal. 
9.2.14.1 
Electronic Diary Training 
Patients will be trained by the site staff on the use of the electronic diary at Screening (Visit 
1) and will be instructed to record their 11-point NRS spasticity score, spasm count, and use 
of antispasticity medications once daily, around the same time each day, preferably in the 
evening before retiring to sleep, throughout the baseline period of at least 7 days prior to 
Visits 2 and 6 and throughout the trial until Visit 9. Following randomization during Visit 2, 
patients will be instructed to log their daily IMP dosing in the electronic diary throughout the 
2 treatment periods until Visit 9. 
9.2.14.2 
Spasticity Numerical Rating Scale 
The 11-point NRS is considered a valid and reliable method to assess overall spasticity in 
patients with MS. It is the standardized patient-related outcome that best identifies a clinically 
important difference and a minimum clinically important difference. 
Patients will be asked to make a daily assessment, at bedtime, to read the question, and to tick 
the most appropriate number to indicate the severity of his or her spasticity over the last 24 
hours. The patients will be given a definition of spasticity and the question will be phrased as 
follows: 
On a scale of 0 to 10, please indicate your level of spasticity over the last 24 hours, 
considering 0 as “No spasticity” and 10 as “Worst possible spasticity.” 
This information will be recorded in the patient electronic diary. 
9.2.14.3 
Use of Antispasticity Medications and Investigational Medicinal 
Product Dosing Record 
Patients will be instructed to record their use of antispasticity medications and their IMP 
dosing daily in their electronic diary. 
9.2.15 
Questionnaires and Assessments Completed at Scheduled Visits 
Questionnaires should be completed by the patient, unless otherwise specified. The same 
person should administer/complete the questionnaires/assessments in order to maintain 
consistency, unless otherwise stated. 


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9.2.15.1 
Modified Ashworth Scale 
The MAS is one of the most widely used methods of measuring spasticity, due in a large part 
to the simplicity and reproducible method17 and reflects the findings of a trained observer and 
not the patients’ perception of symptoms. 
The MAS has 6 categories to classify muscle spasticity and will be conducted and scored by a 
blinded, independent, trained, and certified healthcare professional (i.e., one not otherwise 
involved in the care of the patient within or outside this trial) as follows: 
0) No increase in muscle tone 
1) Slight increase in muscle tone, manifested by a catch and release or minimal 
resistance at end of the range of motion when affected part(s) are moved in flexion or 
extension 
1+) Slight increase in muscle tone, manifested by a catch, followed by minimal resistance 
throughout the remainder (less than half) of the range of movement (ROM) 
2) More marked increase in muscle tone through most of the ROM, but affected part(s) 
easily moved 
3) Considerable increase in muscle tone, passive movement is difficult 
4) Affected part rigid in flexion or extension 
The blinded, independent, trained, and certified healthcare professional will perform the 
MAS assessment, specifically the following 10 muscle groups: hip flexors and adductors, 
knee flexors and extensors, and plantar flexors on both sides of the body at each time point at 
specified visits. The same assessor should administer the MAS throughout the trial where 
possible. 
9.2.15.2 
Multiple Sclerosis Spasticity Scale 
The MSSS-88 is a patient self-report measure of the impact of spasticity (muscle stiffness and 
spasms) in MS. This 88-item scale captures the patient experience and impact of spasticity, 
including muscle stiffness, pain and discomfort, muscle spasms, effect on daily activities, 
ability to walk, body movement, patient feelings, and social functioning. Responses to 
individual questions can range from “not at all bothered” to “extremely bothered.” 
9.2.15.3 
Columbia-Suicide Severity Rating Scale 
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. At Screening (Visit 1), questions will be in relation to lifetime 
experiences (baseline). Questioning at all subsequent visits will be in relation to the last 
assessment (since last visit). 


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The C-SSRS is to be administered by the investigator or his or her qualified designee at 
Visits 1 through 10 as indicated in the schedule of assessments (see Appendix 1); “qualified 
designee” is defined as anyone who has completed the C-SSRS training within the past 
2 years or has continually administered C-SSRS assessments throughout the trial since 
obtaining the training certificate. The survey should be completed by the same assessor, 
where possible, throughout the trial. Assessments will be conducted only if patients are 
capable of understanding and answering the questions, in the investigator’s opinion. 
9.2.15.4 
Timed 25-Foot Walk 
The T25FW is a quantitative measure of lower extremity function. A blinded, independent, 
trained, and certified healthcare professional will perform the T25FW. The same assessor 
should administer the T25FW test throughout the trial where possible. If ambulatory, the 
patient will be instructed to begin at one end of a clearly marked 25-foot course. They will be 
instructed to walk the 25 feet as quickly as possible, but safely, and to not slow down until 
after they have passed the finish line. The task will be immediately administered a second 
time following the first trial by having the patient walk back the same distance. 
Patients will be permitted to use their customary, nonmotorized assistive device (AD) (cane, 
walking sticks, walker, and rollator) during the T25FW test. The same AD must be used at 
each assessment and its use documented in the patient record. 
9.2.16 
Investigational Medicinal Product Accountability 
Records of IMP accountability will be maintained according to Section 5.3.4. 
9.2.17 
Adverse Events 
Refer to Section 12 for definitions, procedures, and further information on AE reporting. 
9.2.18 
Subject Discontinuation 
Patients who are withdrawn (for nondrug related reasons [including COVID-19]) may be 
replaced following discussion between the investigator and the sponsor. Patients withdrawn 
as a result of AEs thought to be related to IMP, as determined by the investigator, will 
generally not be replaced. The decision regarding the replacement of participants will be 
documented. 
9.2.19 
Special Circumstances 
During special circumstances (e.g., COVID-19 pandemic), the specific guidance from local 
public health and other competent authorities regarding the protection of individuals’ welfare 
must be applied. In cases where participants are not able to perform all protocol-defined 
assessments due to special circumstances, the investigator must discuss with the sponsor 
potential mitigation approaches. 


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For the duration of such special circumstances, the following measures may be implemented 
for enrolled subjects: 
x Safety follow-up may be done by a telephone call, other means of virtual contact or 
home visit, if appropriate. 
x Patient and/or clinician-rated outcomes assessments may be done by videoconference, 
telephone call, other means of virtual contact, if possible. 
x An alternative approach for IMP dispensing, secure delivery and collection may be 
sought. 
x Visits may take place in a different location than defined in the protocol. If this is not 
feasible, then the visit may take place virtually with documentation of the means of 
communication (e.g., phone call or videoconference). 
x Biological samples may be collected and analysed at a different location than defined 
in the protocol. Biological samples should not be collected if they cannot be processed 
in a timely manner or appropriately stored until shipping/processing. 
x If despite best efforts it is not possible to collect the biological samples or safety 
assessments (e.g., ECG, vital signs) within the interval predefined in the protocol (see 
the Schedule of Assessments Appendix 1), then the interval may be extended up to a 
maximum length of 7 days. 
x If despite best efforts a safety assessment cannot be performed, the investigator must 
review the benefit-risk for patient continuation in the study and record this in the 
medical records. 
The rationale (e.g., the specific limitation imposed by the special circumstances that led to the 
inability to perform the protocol-specified assessment) and outcome of the discussion with 
the sponsor will be documented in the medical record. Information on how each visit was 
performed will be recorded in the eCRF. 


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10 
WITHDRAWAL 
In accordance with the Declaration of Helsinki, the ICH Tripartite Guideline for GCP Topic 
E6(R2), the US Food and Drug Administration (FDA) regulations relating to GCP and 
clinical trials, the EU Clinical Trials Directive, the EU GCP Directive, and/or other 
applicable regulations, a patient has the right to withdraw from the study at any time and for 
any reason, with no obligation to provide a reason, and without prejudice to his or her future 
medical care by the physician or at the institution. 
The patient must be withdrawn from the trial if any of the following apply: 
x Administrative decision by the investigator, GW, or a regulatory authority 
x Withdrawal of patient consent 
x Lost to follow-up 
The patient must cease IMP and should remain in the trial if any of the following apply: 
x Pregnancy 
x Protocol deviation that is considered to potentially compromise the safety of the 
patient 
x Suicidal behavior or ideation of type 4 or 5 during the treatment period, as evaluated 
with the C-SSRS 
x ALT or AST > 3 u ULN with the appearance of fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, fever, rash, and/or eosinophilia (> 5%) 
x ALT or AST > 5 u ULN 
x ALT or AST > 3 u ULN and (total bilirubin [TBL] > 2 u ULN or international 
normalized ratio [INR] > 1.5) 
The patient may be required to cease IMP at the discretion of the investigator and should 
remain in the trial for any of the following reasons: 
x Did not meet eligibility criteria 
x Patient noncompliance 
x AE (including clinically significant laboratory result) that, in the opinion of the 
investigator, would compromise the continued safe participation of the patient in the 
trial 
x Any evidence of drug abuse or diversion 
x Disease progression (defined as a relapse of MS requiring a change in treatment) 
Should a patient request or decide to withdraw from the study, all efforts must be made to 
complete and report the observations 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 on the applicable eCRF pages (refer to Section 9.2). A Safety 
Follow-up Visit should take place 7 (+ 3) days after last dose of IMP or after the End of 


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Treatment visit (Visit 9), whichever is later (refer to Section 9.1.5). If withdrawing patients 
decline to give a reason for withdrawal of consent, the investigator must respect the patients’ 
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 and 
will provide a written report to the regulatory authorities and IRB/IEC within 3 days. For 
information on IMP overdose, please refer to the IB. 


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12 
ADVERSE EVENT REPORTING 
12.1 
Definitions 
12.1.1 
Adverse Event 
For the purposes of this trial, an AE is defined as follows: 
Any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings 
when relevant) or diagnosis or worsening of a preexisting condition that occurs following 
Screening (Visit 1) and at any point up to the posttreatment Safety Follow-up Visit (Visit 10), 
which may or may not be considered to be related to the IMP. Any event that is the result of a 
trial 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 pretrial existing conditions or elective procedures are not 
AEs. An exception may be if the patient has an AE during hospitalization that prolongs his or 
her 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 trial PI or a formally delegated trial physician. 
12.2 
Serious Adverse Events 
During clinical investigations, AEs may occur that, 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, or consent forms). This is particularly true for events 
that threaten life or function. Such SAEs will be reported promptly to regulatory authorities, 
applicable IRBs/IECs, and investigators (expedited reporting) by GW. 
An AE must only be classed as serious, i.e., an SAE, when the event falls into one of the 
following criteria: 
x Results in death 
x Is life-threatening* 
x Requires inpatient hospitalization or prolongation of existing hospitalization 
x Results in persistent or significant disability/incapacity 
x Is a congenital anomaly/birth defect 
x Is medically significant** 


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*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 that, 
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. 
12.3 
Reporting Procedures for Serious Adverse Events 
All SAEs occurring during the trial must be reported to GW with any other supporting 
information and recorded in the AE section of the eCRF. 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 recorded in the eCRF within 24 hours of discovery or notification of 
the event. The GW Pharmacovigilance Department (PVD) will be automatically notified that 
an SAE has been recorded. Any additional information required for a case (follow-up or 
corrections to the original case) will be requested by GW PVD through eCRF queries. 
The investigator is not obliged to actively monitor for any new SAEs that occurred after the 
last formal Safety Follow-up Visit (Visit 10). 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 after Visit 10 that is deemed to be an unexpected safety issue 
and is likely to have an impact on patients who have taken part in the trial must be treated as 
an SAE and reported to the GW PVD. Such posttrial SAEs do not need to be recorded on the 
patient’s eCRF if editing rights to the eCRF have been removed due to final trial database 
lock. GW PVD may request safety follow-up information after the final trial visit in order to 
investigate a potential safety issue. 
Contact details for the GW PVD are provided at the front of the site files for all trial sites and 
upon completion of the GW SAE report form. 


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12.4 
Pregnancy 
Any patient, or patient’s partner, who has become pregnant while receiving the IMP, or 
within 3 months of the last dose of IMP, must be reported to the GW PVD. Where possible, 
the investigator should provide the outcome of the pregnancy. 
All pregnancies must be recorded in the eCRF within 24 hours of awareness. The GW PVD 
will be automatically notified that a pregnancy has been recorded. Any additional information 
required for a case (follow-up or corrections to the original case) will be requested by GW 
PVD through eCRF queries. 
The investigator is not obliged to actively monitor for any pregnancies that commence more 
than 3 months after the final dose of IMP. However, if the investigator becomes aware of a 
new pregnancy outside this time limit, then he/she 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.” 
Events that start before the first dose of IMP (pretreatment) should be considered as not 
causally related. Where a pretreatment event worsens in severity following the first dose of 
IMP, a new event record should be entered into the eCRF. 
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 the following: 


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x Medical and disease history 
x Lack of efficacy/worsening of treated condition 
x Concomitant or previous treatment 
x Withdrawal of IMP 
x Protocol-related procedure 
12.6 
Reporting Procedures for All Adverse Events 
All AEs (including SAEs) occurring during the trial will be reported on the running logs in 
the AE section of the eCRF. This includes all events from the time following Screening 
(Visit 1) up to and including the Safety Follow-up Visit (Visit 10), 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 eCRF. Once a diagnosis has been determined, the AE section of the 
eCRF 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 eCRF 
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., symptom due to disease (i.e., weakness due to 
cancer, tremor due to MS, headache and fever due to pneumonia, and generalized weakness 
due to hepatic cancer progression). 
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, much 
information as possible (i.e., month and year or, in exceptional circumstances, just year) 
should be recorded. When the actual start date becomes known, the eCRF must be updated to 
replace the previously recorded date. 


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C) 
Outcome 
The outcome of the event must be recorded accurately and classified into one of the 
following categories: 
x Recovered/Resolved 
x Recovered/Resolved with Sequelae 
x Not Recovered/Not Resolved 
x Fatal 
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 an 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 
classified as serious. 
E) 
Causality 
See Section 12.5 above. 
F) 
Action Taken With Trial Medication 
This question refers to the action taken with the IMP due to an AE. The action with the IMP 
must be classed as follows: 
x Dose Not Changed 
x Dose Reduced 
x Drug Interrupted 
x Drug Withdrawn 
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 after Visit 10, after the trial. 
Adverse events 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 withdrawal from treatment. A patient may also voluntarily 


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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 patient, GW may contact the investigator for additional follow-up 
information. 
12.8 
Potential Cases of Drug-induced Liver Injury 
All trial sites are required to submit to the GW PVD the laboratory results of any patient after 
randomization who meets the criteria for the following selected laboratory parameters: 
x ALT or AST > 3 u ULN with the appearance of fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, fever, rash, and/or eosinophilia (> 5%) 
x ALT or AST > 8 u ULN 
x ALT or AST > 5 u ULN for more than 2 weeks 
x ALT or AST > 3 u ULN and (TBL > 2 u ULN or INR > 1.5) 
These reports must be sent to the GW PVD via email within 24 hours of awareness of the 
results (see Appendix 2 for GW PVD contact details). In addition, a copy of the patient’s 
baseline laboratory results together with all reports must be sent to the GW PVD. Any 
laboratory results that constitute an AE in the investigator’s opinion must be recorded in the 
eCRF. Where the results are considered to be SAEs, these must be recorded in the eCRF 
within 24 hours of becoming aware of the result, in line with reporting procedures for SAEs 
(Section 12.3). 
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 IMP discontinuation and important medical 
events. The investigator will arrange for the patient to return to the trial site as soon as 
possible (within 24 hours of notice of abnormal results) for repeat assessment of ALT, AST, 
TBL, alkaline phosphatase, gamma-glutamyl transferase, INR, and hematology parameter 
levels; detailed history; and physical examination. Patients should be followed this way until 
all abnormalities have normalized (in the investigator’s opinion) or returned to the baseline 
state. 
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 patient cannot return to the trial site, repeat assessments may 
be done at a local laboratory and the results sent to GW PVD. 


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12.9 
Notification of Safety Information to Investigators, Regulatory 
Authorities, and Institutional Review Boards/Independent Ethics 
Committees 
In accordance with the EU Clinical Trials Directive, relevant parts of the FDA Code of 
Federal Regulations, and any national regulations, GW will inform investigators, regulatory 
authorities, and relevant IRBs/IECs of all relevant safety information. This will include the 
reporting of relevant SAEs and all suspected unexpected serious adverse reactions 
(SUSARs). 
This information will be provided through 3 sources: 
1) IB15: this document is a compilation of the clinical and nonclinical safety data 
available on the IMP that are relevant to the trial. The IB is updated annually. 
2) Development core safety information: this document forms the safety section of the 
IB15 or is updated as an addendum to the IB15. This document is revised, if necessary, 
when new important safety information becomes available. 
3) Council for International Organizations of Medical Sciences (CIOMS) reports: these 
reports are issued every time a SUSAR is reported to GW. These provide information 
on individual case reports and are sent to all the regulatory authorities, the relevant 
central ethics committees that have approved the trial, and the investigators. As 
required, the investigator should notify their regional IRBs/IECs of SAEs or SUSARs 
occurring at their trial site and other AE reports, i.e., CIOMS reports and any 
additional safety documentation received from GW, in accordance with local 
procedures. 
In the US, investigators are normally required to report promptly to their IRBs all 
unanticipated problems involving risks to patients or others, including AEs that should be 
considered unanticipated problems. Based on current FDA guidance, the following 
clarification is provided in determining what constitutes an unanticipated problem: 
In general, an AE observed during the conduct of a trial 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 trial (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, or 
IB). An individual AE occurrence ordinarily does not meet these criteria because, as an 
isolated event, its implications for the trial cannot be understood. 
The FDA guidance states that, accordingly, to satisfy the investigator’s obligation to notify 
the IRB of unanticipated problems, any investigators participating in a multicenter trial may 


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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 IRBs/IECs 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 trial 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 
Further details of the proposed statistical analysis will be documented in a statistical analysis 
plan (SAP), which will be produced prior to unblinding of the trial. Any deviations from the 
original SAP will be described in the final clinical study report. 
13.1 
Sample Size, Power, and Significance Levels 
Approximately 95 patients will be randomly assigned to each treatment sequence to ensure 
that at least 170 patients in total complete the 2 treatment periods. This assumes a true 
difference of -0.18, and standard deviation (SD) for paired differences of 0.71 for 
90% power. 
If more than 20 patients withdraw from the study, additional patients will be enrolled to have 
at least 170 completers. 
The primary comparison will be the estimate of the mean treatment difference between 
nabiximols and placebo in the mean change from baseline in Lower Limb Muscle Tone-6 
(LLMT-6). 
SAS software version 9.4 was used to perform the sample size calculations. 
13.2 
Interim Analysis 
No formal interim analysis will be conducted. However, additional data, collected outside of 
this trial, may become available during study conduct. Based on such data, the sample size 
may be recalculated using a blinded reassessment and updated assumptions of treatment 
effect and variability, while maintaining study blind and type 1 error. 
13.3 
Analysis Sets 
The following analysis sets will be used for the statistical analysis: 
Full Analysis Set 
x All patients who signed the informed consent and were randomized, received at least 
1 dose of IMP in the trial, and have post-baseline efficacy data will be included and 
analyzed according to their randomized treatment. 
x The Full Analysis Set (FAS) is the primary analysis set for all efficacy endpoints. 
Pharmacokinetic Analysis Set 
x All patients who have received at least 1 dose of IMP and provided sufficient 
bioanalytical data to calculate reliable (based on the judgement of the 
pharmacokineticist) estimates of the PK parameters will be included in the PK 
Analysis Set. 


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Safety Analysis Set 
x All patients who received at least 1 dose of IMP in the trial will be included in the 
Safety Analysis Set and analyzed according to the treatment received. Only patients 
for whom it has been confirmed that they did not take IMP will be excluded from the 
Safety Analysis Set. The Safety Analysis Set will be used to report all safety data. 
Per Protocol Analysis Set 
If there are a sufficient number of significant protocol deviations in the trial, a Per Protocol 
(PP) Analysis Set may also be presented. The PP Analysis Set is defined as follows: 
A subset of the FAS that includes all patients who have completed the trial with no 
major protocol deviations deemed to compromise the assessment of efficacy.  Major 
protocol deviations will be identified and fully defined prior to unblinding of the trial. 
The PP analysis will only be conducted on efficacy endpoints and patients analyzed 
according to their randomized treatment. 
13.3.1 
Protocol Deviations 
Protocol deviations will be listed, and reasons for exclusion from the analysis sets (for major 
protocol deviations) will be summarized. 
13.4 
General Considerations 
Unless stated otherwise, continuous variables will be summarized showing the number of 
non-missing values (n), mean, SD, median, minimum, and maximum. Categorical variables 
will be summarized showing the number and percentage of patients falling in each category. 
For patient electronic diary-based endpoints, baseline is defined as the average of the last 
7 days of electronic diary entries prior to randomization (Visit 2). 
For clinic-based endpoints, baseline is defined as the last record or measure collected prior to 
the first dose of IMP in each treatment period. 
13.5 
Accountability and Background Characteristics 
13.5.1 
Enrollment and Disposition 
All patients (screened, received IMP, prematurely terminated IMP, etc.) will be accounted for 
in the enrollment and disposition summary tables. 
13.5.2 
Baseline and Demographic Characteristics 
Age, sex, race (per local data protection laws), and other demographic or baseline 
characteristics will be summarized by treatment sequence using appropriate summary 
statistics. There will be no formal comparison of baseline data. 


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13.5.3 
Medical History 
Previous and current medical conditions will be summarized by system organ class (SOC) 
and preferred term (PT) by treatment sequence. 
13.5.4 
Concomitant Medication 
Prior medication will be summarized by treatment sequence and concomitant medications 
taken during the trial will be summarized by treatment period. 
13.6 
Endpoints and Statistical Methods 
The primary efficacy endpoint will be analyzed as detailed in Section 13.6.2. The secondary 
efficacy endpoint will be analyzed as detailed in Section 13.6.3. The exploratory efficacy 
endpoints will be analyzed as detailed in Section 13.6.4. The PK data will be summarized as 
detailed in Section 13.6.5. Safety endpoints will be summarized as detailed in Section 13.6.6. 
13.6.1 
Evaluable Period 
The evaluable period starts on the day of randomization. The end of the evaluable period is 
defined as the Safety Follow-up Visit (Visit 10). 
13.6.2 
Primary Endpoint 
The primary endpoint is the change in LLMT-6 from Day 1 predose to Day 21 and from Day 
31 predose to Day 51. The MAS scores are transformed using the following algorithm: MAS 
untransformed [to MAS transformed] scores; 0[0], 1[1], 1+[2], 2[3], 3[4], and 4[5]. 
The primary estimand involves the mean treatment difference (nabiximols í placebo) in the 
mean change from baseline in LLMT-6 from Day 1 (predose) to Day 21 and from Day 31 
(predose) to Day 51 for all randomized patients. 
For any given patient, at a given visit, the LLMT-6 will be set to missing if individual MAS 
transformed scores are missing for 3 or more of the 6 specified muscle groups. 
The change from baseline in LLMT-6 will be analyzed using a linear mixed-effects model for 
crossover data. The model will include a period level LLMT-6 baseline covariate, and 
treatment, period, and treatment sequence as fixed effects, and patient nested within treatment 
sequence as a random effect. Mean change from baseline in LLMT-6 will also be 
summarized by treatment sequence, over time. 
The least squares mean estimates for each treatment, along with the standard error and 95% 
confidence intervals (CIs), will be presented. In addition, estimate of the mean treatment 
difference in change from baseline in LLMT-6 will be presented along with standard errors of 
the difference and 95% CIs. 


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If the data appear to not be normally distributed, alternative approaches such as 
transformation of the data and nonparametric analyses may be considered to express 
treatment effects. This will be specified in detail in the SAP. 
Further details of statistical analyses will be elaborated in the SAP. 
13.6.3 
Secondary Efficacy Endpoint 
The change in Lower Limb Muscle Tone-4 (LLMT-4; defined as the average of the 
4 individual MAS transformed scores of knee flexors and knee extensors on both sides of the 
body) from Day 1 predose to Day 21 and from Day 31 predose to Day 51 will be analyzed in 
a similar way to the primary endpoint. 
For any given patient, at a given visit, the LLMT-4 will be set to missing if individual MAS 
transformed scores are missing for 2 or more of the 4 specified muscle groups. To control for 
Type 1 error, the primary efficacy endpoint and the secondary efficacy endpoint will be 
tested hierarchically, starting with the primary efficacy endpoint and followed by the 
secondary efficacy endpoint. No adjustments for multiplicity will be made for other 
secondary or exploratory endpoints. 
13.6.4 
Exploratory Efficacy Endpoints 
The exploratory endpoints are as follows: 
x Change in Timed 25-Foot Walk (T25FW) test from Day 1 predose to Day 21 and 
from Day 31 predose to Day 51 
x Average 11-point NRS spasticity score over the last 7 days of each double-blind 
treatment period 
x Average daily spasm count over the last 7 days of each double-blind treatment period 
x Total and subdomain scores of the MSSS-88 at the end of the maintenance-dose phase 
of each double-blind treatment period 
These endpoints will be analyzed using the methods used for the primary endpoint described 
in Section 13.6.2 and this will be detailed in the SAP. 
13.6.5 
Pharmacokinetics 
Plasma concentration for THC and its relevant metabolites (11-OH-THC and 
11-COOH-THC) and CBD and its relevant metabolites (7-OH-CBD and 7-COOH-CBD) will 
be summarized by treatment period together with any estimates of PK parameters. 
This data will undergo a population PK analysis and will be presented in a stand-alone report. 


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13.6.6 
Safety 
The safety endpoints are listed below and will be compared with placebo as detailed in the 
following subsections:  
x Frequency of TEAEs 
x Change from baseline to each assessment time point by treatment period for the 
following: 
x Clinical laboratory parameters 
x Vital signs 
x Physical examination procedures 
x 12-Lead ECGs 
x Columbia-Suicide Severity Rating Scale (C-SSRS) will be summarized at screening, 
and at each subsequent time point with reference to the last assessment (since last 
visit) 
13.6.6.1 
Treatment Compliance and Extent of Treatment Exposure 
Treatment compliance and exposure to treatment will be summarized. 
13.6.6.2 
Adverse Events 
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities 
dictionary. 
A TEAE is one that started, or worsened in severity or seriousness, following the first dose of 
IMP. 
Descriptive presentations of TEAEs will be given by PT and SOC for the Safety Analysis 
Set. The number of patients reporting at least 1 TEAE will be provided. 
The following summaries will be produced at a minimum: 
x All-causality TEAEs 
x Treatment-related TEAEs 
x All-causality TEAEs by maximal severity 
x All-causality serious TEAEs 
x Treatment-related serious TEAEs 
x TEAEs reported as leading to permanent cessation of IMP 
x Fatal TEAEs 
13.6.6.3 
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 


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summary statistics. Categorical shift tables will also be presented showing the numbers of 
patients with values outside the normal range. Changes from baseline to each visit will be 
summarized. 
13.6.6.4 
Vital Signs, 12-Lead Electrocardiogram, Physical Examination, and 
Other Safety Data 
Vital signs, 12-lead ECG, physical examination, and C-SSRS data will be summarized for the 
Safety Analysis Set at screening, baseline, and each time point during the treatment period 
using appropriate summary statistics, as applicable. Changes in vital signs from baseline to 
each assessment post-baseline will also be summarized. 


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14 
DATA SAFETY MONITORING COMMITTEE 
There will not be a data safety monitoring committee involved in this trial. 


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15 
REGULATORY AND ETHICAL OBLIGATIONS 
15.1 
Declaration of Helsinki 
The investigator will ensure that this trial is conducted in full conformity with the current 
version and subsequent amendments of the Declaration of Helsinki, the ICH Tripartite 
Guideline for GCP Topic E6(R2), the EU Clinical Trials Directive, the EU GCP Directive, 
and the clinical trial regulations adopting European Commission Directives into national 
legislation. 
15.2 
Informed Consent 
Initial master informed consent will be prepared by GW and provided to the investigator, 
who will tailor this for their trial site by adding the site’s contact details and by using headed 
paper. The GW clinical manager will communicate updates to the template by letter. The 
written informed consent document 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 from the patient after adequate explanation of the aims, methods, 
anticipated benefits, and potential hazards of the trial and before any trial-specific procedures 
are performed or any patient-related data are recorded for the trial. The patient must have 
ample time to consider the information provided before giving written consent. More specific 
definitions of “ample time” may be in force if required by IRBs/IECs or local regulations. 
The acquisition of informed consent must be documented in the patient’s medical records, 
and the ICF must be signed and personally dated by the patient and by the person who 
conducted the informed consent discussion. The original signed ICF should be retained and a 
copy should be provided to the patient. 
15.3 
Institutional Review Board/Independent Ethics Committee 
A copy of the protocol, proposed ICFs, master ICF, other patient information material, any 
proposed advertising material, and any further documentation requested must be submitted to 
the IRB/IEC for written approval. GW must receive a copy of the written approval of the 
appropriate version of the protocol and ICF before recruitment of patients into the trial and 
shipment of IMP. 
The investigator must submit and, where necessary, obtain approval from the IRB/IEC for all 
subsequent protocol amendments and changes to the informed consent document. The 
investigator must notify the IRB/IEC of deviations from the protocol, SAEs occurring at the 
trial site, and other AE reports received from GW, in accordance with local procedures. 


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The investigator will be responsible for obtaining ongoing IRB/IEC approval/renewal 
throughout the duration of the trial. Copies of the investigator’s reports and the IRB/IEC 
continuance of approval must be sent to GW. 
15.4 
Pretrial Documentation Requirements 
The investigator is responsible for forwarding the following documents to GW for review 
before allowing any patients to consent for entry into the trial: 
x Signed and dated protocol signature page 
x Copy of IRB/IEC-approved ICF (including version number and date) and other 
patient information material 
x Copy of the IRB/IEC approval of the protocol, ICF (including version number and 
date), and other patient information material 
x Up-to-date curricula vitae and medical licenses (per local regulations) of the PI and all 
subinvestigators 
x The IRB/IEC composition and/or written statement of the IRB/IEC in compliance 
with the FDA regulations relating to GCP and clinical trials, the EU Clinical Trials 
Directive, the EU GCP Directive, or the ICH Tripartite Guideline for GCP Topic 
E6(R2), where the EU Clinical Trials and GCP Directives do not apply 
x Signed and dated laboratory normal ranges and documentation of laboratory 
certification (or equivalent) unless using central laboratory arranged by GW 
x Signed and dated clinical trial agreement (including patient/investigator indemnity 
insurance and financial agreement) 
x Form FDA 1572, if required 
x Drug Enforcement Administration license (where applicable) 
x Completed financial disclosure statements for the PI and all subinvestigators, if 
relevant 
GW will ensure that the trial site is informed of when screening of patients can commence. 
15.5 
Patient Confidentiality 
The investigator must ensure that the patient’s anonymity is maintained. In the eCRFs and 
within electronic data capture databases used to collect the trial data or other documents 
submitted to GW, patients should be identified by their year of birth and race (if allowed per 
local regulations). 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 GCP and clinical trials and the EU 
Clinical Trials Directive/ICH Tripartite Guideline for GCP Topic E6(R2), it is required that 
the investigator and institution permit authorized representatives of the company, the 
regulatory authorities, and the IRB/IEC to have direct access to review the patient’s original 


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medical records for verification of trial-related procedures and data. Direct access includes 
examining, analyzing, verifying, and reproducing any records and reports that are important 
to the evaluation of the trial. The investigator is obligated to inform the patient that his or her 
trial-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 trial 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 Trial 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 document. The IRB/IEC and regulatory authorities must be informed of all 
amendments and give approval for any substantial amendments. Amendments for 
administrative changes can be submitted to the IRB/IEC for information only. The 
investigator must send a copy of the approval letter from the IRB/IEC to GW. 
Both GW and the investigator reserve the right to terminate the trial according to the clinical 
trial agreement. The investigator must notify the IRB/IEC in writing of the trial’s completion 
or early termination and send a copy of the notification to GW. 
16.2 
Trial Documentation and Storage 
The investigator must maintain a list of appropriately qualified persons to whom he/she has 
delegated trial duties. All persons authorized to make entries in and/or corrections to eCRFs 
will be included on the GW Delegation of Authority and Signature form. 
Source documents are original documents, data and records containing all protocol-specified 
information from which the patient’s eCRF data are obtained. These include, but are not 
limited to, hospital records, clinical and office charts, laboratory and pharmacy records, 
diaries, microfiches, radiographs, and correspondence. A source data verification plan, 
identifying the source for each data point at each trial site, will be agreed upon with each trial 
site prior to patient recruitment. In the rare situations of data being recorded directly into the 
eCRF in error, then the source data from the eCRF should be transcribed into the patient’s 
notes with appropriate signature and date to provide a full audit trail. 
The investigator and trial staff are responsible for maintaining a comprehensive and 
centralized filing system of all trial-related, essential documentation (as outlined in the ICH 
Tripartite Guideline for GCP Topic E6(R2), Section 8.2), suitable for inspection at any time 
by representatives from GW and/or applicable regulatory authorities. Elements should 
include the following: 
x Patient files containing completed eCRFs, ICFs, and supporting copies of source 
documentation 
x Trial files containing the protocol with all amendments, IB, copies of pretrial 
documentation (see Section 15.4), and all correspondence to and from the IRB/IEC 
and GW 
x Enrollment log of all patients who consented to take part in the trial 
x Screening and recruitment log of all patients screened and whether or not they were 
recruited into the trial (i.e., randomized and/or dosed with IMP) 


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x 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 eCRFs and electronic 
diary data must be maintained and be readily available. 
Following completion or termination of a clinical trial, GW will initiate proper archive of 
clinical trial-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 on need and for a minimum of 25 years. Essential 
documents must be retained until at least 2 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 2 years have elapsed since the formal 
discontinuation of clinical development of the IMP. These documents must be retained for a 
longer period, however, if required by the applicable regulatory requirements or if needed by 
GW. 
GW will inform the investigators for each trial site in writing of the need for record retention. 
No trial document may be destroyed without prior written agreement between GW and the 
investigator. Should the investigator wish to assign the trial 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 
Trial 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 trial, e.g., eCRFs and other pertinent data, provided that 
patient confidentiality is respected. 
The GW trial monitor, or designee, is responsible for inspecting (onsite or remotely) the 
eCRFs and available electronic diary data at regular intervals throughout the trial 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 trial monitor must have access to 
patient medical records and other trial-related records needed to verify the entries on the 
eCRFs. 
The investigator agrees to cooperate with the trial 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 sites, 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 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
Confidential 
Page 85 of 94 
 
Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
and FDA regulations, ICH Tripartite Guideline for GCP Topic E6(R2), and all other 
applicable regulatory requirements. To resolve any questions arising from the clinical data 
management review process, data queries and/or site notifications will be sent to the trial site 
for completion and then returned to GW or the CRO, as applicable. 
16.4 
Quality Assurance 
In accordance with the FDA regulations, EU Clinical Trials Directive/ICH Tripartite 
Guideline for GCP Topic E6(R2), and the sponsor’s audit plans, representatives from GW’s 
Clinical Quality Assurance Department may select this trial for audit. Inspection of site 
facilities (e.g., pharmacy, drug storage areas, and laboratories) and review of trial-related 
records will occur to evaluate the trial conduct and compliance with the protocol, the EU 
Clinical Trials Directive/ICH Tripartite Guideline for GCP Topic E6(R2), and applicable 
regulatory requirements. 
16.5 
Compensation 
GW will indemnify the investigator and the trial site in the event of any claim in respect of 
personal injury arising due to a patient’s involvement in the trial providing that the trial 
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 trial 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. 
16.6 
Publication Policy 
GW recognizes that there is a responsibility under the regulatory guidelines to ensure that 
results of scientific interest arising from this clinical trial are appropriately published and 
disseminated. They will coordinate this dissemination and may solicit input and assistance 
from the chief/PIs. A summary of the results of this trial will be made available on 
http://www.clinicaltrials.gov and http://www.clinicaltrialsregister.eu/ (as applicable), as 
required by US and EU laws, respectively. 
Any publication of the trial data will be made in accordance with the terms of the 
Clinical Trial Agreement. 
All publications, e.g., manuscripts, abstracts, oral/slide presentations, or book chapters, based 
on this trial 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 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
Confidential 
Page 86 of 94 
 
Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
dissemination, or review by a publication 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 
6 months from the date of first submission to them in order to allow them to take steps to 
protect proprietary information where applicable. 
16.7 
Intellectual Property Rights 
All intellectual property rights owned by or licensed to either GW or the PIs, other than those 
arising from the clinical trial, will remain their property. All intellectual property rights 
arising out of the clinical trial will vest in or be exclusively licensed to GW and, as such, the 
PI must promptly disclose all knowledge to GW and refrain from using such knowledge 
without the prior written consent of GW. 
16.8 
Confidential Information 
GW and the PI must ensure that only personnel directly concerned with the trial are party to 
confidential information and that any information coming to either party about the other 
during the course of the trial must be kept strictly confidential and must not be disclosed to 
any third party or made use of without the prior written consent of the other. 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
Confidential 
Page 87 of 94 
 
Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
17 
REFERENCES 
1 
Zettl UK, Stüve O, Patejdl R. Immune-mediated CNS diseases: a review on nosological 
classification and clinical features. Autoimmun Rev. 2012;11:167-73. 
2 
Kutzelnigg A, Lassmann H. Pathology of multiple sclerosis and related inflammatory 
demyelinating diseases. Handb Clin Neurol. 2014;122:15-58. 
3 
Browne P, Chandraratna D, Angood C, et al. Atlas of Multiple Sclerosis 2013: A growing 
global problem with widespread inequity. Neurology 2014;83:1022-4. 
4 
Zettl UK, Henze T, Essner U, Flachenecker P. Burden of disease in multiple sclerosis 
patients with spasticity in Germany: mobility improvement study (Move 1). Eur J Health 
Econ. 2013;15:953-66. 
5 
Svensson J, Borg S, Nilsson P. Costs and quality of life in multiple sclerosis patients with 
spasticity. Acta Neurol Scand. 2014;129:13-20. 
6 
Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmet TL. Prevalence and treatment of 
spasticity reported by multiple sclerosis patients. Mult Scler. 2004;10:589-95. 
7 
Goldenberg MM. Multiple sclerosis review. P T. 2012;37:175-84. 
8 
Barnes MP, Kent RM, Semlyen JK, McMullen KM. Spasticity in multiple sclerosis. 
Neurorehabil Neural Repair. 2003;17:66-70. 
9 
Beard S, Hunn A, Wight J. Treatments for spasticity and pain in multiple sclerosis: a 
systematic review. Health Technology Assessment. 2003;7:1-111. 
10 Flachenecker P, Henze T, Zettl UK. Spasticity in patients with multiple sclerosis clinical 
characteristics, treatment and quality of life. Act Neurol Scand. 2004;129:154-62. 
11 Arroyo R, Massana M, Vila C. Correlation between spasticity and quality of life in 
patients with multiple sclerosis: the CANDLE study. Int J Neurosci. 2013;123:850-8. 
12 Henze T, Rieckmann P, Toyka KV. Symptomatic treatment of multiple sclerosis. 
Multiple Sclerosis Therapy Consensus Group (MSTCG) of the German Multiple 
Sclerosis Society. Eur Neurol. 2006;56:78-105. 
13 Kister I, Bacon TE, Chamot E, et al. Natural history of multiple sclerosis symptoms. Int J 
MS Case. 2013;15:146-58. 
14 Arroyo R, Vila C, Clissold S. Retrospective observational study of the management of 
multiple sclerosis patients with resistant spasticity in Spain: the '5E' study. Expert Rev 
Pharmacoecon Outcomes Res. 2011;11:205-13. 
15 Investigator's Brochure: Sativex Oromucosal Spray. GW Pharma Ltd. Edition 22.1 and 
Addendum 1, January 2020. 
16 Leocani L, Nuara A, Houdayer E, et al. Sativex and clinical-neurophysiological measures 
of spasticity in progressive multiple sclerosis. J Neurol. 2015;262(11):2520-7. 
17 Ansari NN, Naghdi S, Arab TK, Jalaie S. The interrater and intrarater reliability of the 
Modified Ashworth Scale in the assessment of muscle spasticity: limb and muscle group 
effect. NeuroRehabilitation. 2008;23:231-7. 
 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
Confidential 
Page 88 of 94 
 
Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
Appendix 1 
SCHEDULE OF ASSESSMENTS 
Period 
Screening 
Treatment Period 1 
Treatment Period 2 
Safety 
Follow- 
up 
Visit Number 
Visit 1 
Visit 2 
Visit 3 
(Phone C
all) 
Visit 4 
Visit 5a 
Visit 6 
Visit 7 
(Phone 
Call) 
Visit 8 
Visit 9 
Visit 10 
(or 7 days 
after 
final IMP 
dose or 
EoT visit) 
Day/Hour  
Days -28 
to -1 
Day 1 
predose 
Day 1 
2-4 hrs 
postdose 
Day 8 
(±1 day) 
Day 15 
(±1 day) 
Day 21 
(±2 days) 
Day 31 
predose 
(±1 day) 
Day 31 
2-4 hrs  
postdose 
Day 38 
(±1 day)  
Day 45 
(±1 day) 
Day 51 
(±2 days) 
End of 
Treatment 
Visit 
Day 58 
(+ 3 days) 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
Eligibility check 
X 
X 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
Previous cannabis 
use 
X 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
Electronic diary 
training 
X 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
Concomitant 
medications 
Assessed at each visit 
AEs 
Assessed at each visit 
Physical 
examinationb 
X 
 
 
 
 
X 
 
 
 
 
X 
 
Examination of oral 
mucosa 
X 
X 
 
 
X 
X 
X 
 
 
X 
X 
X 
Body weight 
measurement 
X 
X 
 
 
 
 
X 
 
 
 
 
X 
Vital signs 
X 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
X 
12-lead ECG 
X 
 
 
 
 
X 
 
 
 
 
X 
 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
Confidential 
Page 89 of 94 
 
Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
Period 
Screening 
Treatment Period 1 
Treatment Period 2 
Safety 
Follow- 
up 
Visit Number 
Visit 1 
Visit 2 
Visit 3 
(Phone C
all) 
Visit 4 
Visit 5a 
Visit 6 
Visit 7 
(Phone 
Call) 
Visit 8 
Visit 9 
Visit 10 
(or 7 days 
after 
final IMP 
dose or 
EoT visit) 
Day/Hour  
Days -28 
to -1 
Day 1 
predose 
Day 1 
2-4 hrs 
postdose 
Day 8 
(±1 day) 
Day 15 
(±1 day) 
Day 21 
(±2 days) 
Day 31 
predose 
(±1 day) 
Day 31 
2-4 hrs  
postdose 
Day 38 
(±1 day)  
Day 45 
(±1 day) 
Day 51 
(±2 days) 
End of 
Treatment 
Visit 
Day 58 
(+ 3 days) 
Clinical laboratory 
blood sampling 
(hematology and 
biochemistry) 
X 
 
 
 
 
X 
 
 
 
 
X 
 
Dipstick urinalysis 
X 
 
 
 
 
 
 
 
 
 
 
X 
Urine drug screen 
(including THC) 
X 
X 
 
 
 
 
 
 
 
 
 
 
Serum/urine 
pregnancy test (if 
appropriate)c 
X 
X 
 
 
 
 
X 
 
 
 
 
X 
Blood THC test 
X 
 
 
 
 
 
 
 
 
 
 
 
PK blood sampling 
(IMP)d 
 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
 
Electronic daily diary 
11-Point NRS 
spasticitye 
X 
X 
 
 
X 
X 
X 
 
 
X 
X 
 
Daily spasm 
counte 
X 
X 
 
 
X 
X 
X 
 
 
X 
X 
 
Use of 
antispasticity 
medicationse 
X 
X 
 
 
X 
X 
X 
 
 
X 
X 
 
IMP dosing 
recorde 
 
X 
 
 
X 
X 
X 
 
 
X 
X 
 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
Confidential 
Page 90 of 94 
 
Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
Period 
Screening 
Treatment Period 1 
Treatment Period 2 
Safety 
Follow- 
up 
Visit Number 
Visit 1 
Visit 2 
Visit 3 
(Phone C
all) 
Visit 4 
Visit 5a 
Visit 6 
Visit 7 
(Phone 
Call) 
Visit 8 
Visit 9 
Visit 10 
(or 7 days 
after 
final IMP 
dose or 
EoT visit) 
Day/Hour  
Days -28 
to -1 
Day 1 
predose 
Day 1 
2-4 hrs 
postdose 
Day 8 
(±1 day) 
Day 15 
(±1 day) 
Day 21 
(±2 days) 
Day 31 
predose 
(±1 day) 
Day 31 
2-4 hrs  
postdose 
Day 38 
(±1 day)  
Day 45 
(±1 day) 
Day 51 
(±2 days) 
End of 
Treatment 
Visit 
Day 58 
(+ 3 days) 
MASf 
X 
X 
X 
 
 
X 
X 
X 
 
 
X 
 
MSSS-88 
 
 
 
 
 
X 
 
 
 
 
X 
 
T25FW testg 
 
X 
 
 
 
X 
X 
 
 
 
X 
 
C-SSRS 
X 
X 
 
 
X 
X 
X 
 
 
X 
X 
X 
IMP dosing training 
 
X 
 
 
 
 
 
 
 
 
 
 
IMP dosingh 
 
X 
 
 
 
X 
X 
 
 
 
X 
 
IMP dispensingi 
 
X 
 
 
X 
 
X 
 
 
X 
 
 
IMP collection and 
compliance review 
 
 
 
 
X 
X 
 
 
 
X 
X 
 
AE = adverse events; C-SSRS = Columbia-Suicide Severity Rating Scale; ECG = electrocardiogram; EoT = end of treatment; IMP = investigational medicinal product; MAS = Modified 
Ashworth Scale; MS = multiple sclerosis; MSSS-88 = Multiple Sclerosis Spasticity Scale; NRS = Numerical Rating Scale; PK = pharmacokinetics; T25FW = Timed 25-Foot Walk; 
THC = ǻ9-tetrahydrocannabinol. 
a A washout period of at least 7 days will separate the 2 treatment periods. Following the final dose of IMP in Treatment Period 1, in the morning of Visit 5 (Day 21), patients will 
discontinue treatment with IMP for the 7 days prior to Visit 6 (Day 31). During the washout period, patients will continue to take their current MS antispasticity medications without any 
changes in dose. 
b A comprehensive physical examination, including an assessment of height, will be completed at Screening (Visit 1) only; subsequent physical examinations will be symptom-directed. 
c Serum pregnancy test at Visits 1 and 10; urine pregnancy test at Visits 2 and 6 (predose). 
d On the day before PK blood sampling at Visits 4, 5, 8, and 9, patients will be prompted to record whether they started their morning and evening doses of IMP within 30 minutes of a snack 
or meal. On the day of PK blood sampling, the exact time and date of PK blood sampling and the time of the patient’s snacks and meals should be recorded. See Section 9.2.12.1 for the 
PK blood sampling schedule. Please note that more than one PK sample may be collected at distinct time points during a single visit. 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
Confidential 
Page 91 of 94 
 
Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
e Patients will record their 11-point NRS spasticity score, spasm count, and use of antispasticity medications in an electronic diary once daily, around the same time each day, preferably in 
the evening before retiring to sleep, for at least 7 days prior to Visits 2 and 6 and throughout the trial until Visit 9. Investigational medicinal product dosing will be recorded by the patient 
in an electronic diary from Visits 2 through 9. 
f MAS assessments will occur at Visit 1 (Screening) and at scheduled time points before (Visits 2 and 6 [predose]) and after (Visits 2, 5, 6, and 9 [3 hours ±15 minutes postdose]) IMP 
administration; for Visits in which the morning dose consists of more than 1 spray (Visits 5 and 9), postdose assessments will occur 3 hours ±15 minutes after the first spray of the 
morning dose. 
g Non-ambulatory patients are not expected to perform the T25FW test. 
h IMP administration of the morning dose will occur at the trial site within 30 minutes after a standardized snack containing at least 300 kcal (of which approximately 30 kcal is composed of 
fat) under the supervision of site staff. On the days of scheduled MAS assessments other than Visit 1, patients who are taking antispasticity therapy should take their regular morning dose 
at least 1 hour before administration of IMP; IMP will not be administered in the evening of Days 21 and 51. 
i In cases where patients are not able to attend study visits due to special circumstances (e.g., COVID-19 pandemic), the investigator will discuss with the Sponsor potential mitigation 
approaches for IMP dispensing, secure delivery, and collection. 
 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
Confidential 
Page 92 of 94 
 
Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
Appendix 2 
TRIAL PERSONNEL 
Appendix 2.1 
Investigator Details 
At the time of protocol production, the participating investigators have not been confirmed. A 
list of all investigators will be maintained within the GW master files (electronically and 
added to the trial master file at the end of the trial). 
Appendix 2.2 
Sponsor Contact Details 
Pharmacovigilance Department 
Email: pvd@gwpharm.com 
Fax: +44 (0)1223 233 319 
USA Toll-free Fax: 
+1-866-234-1751 
Tel: +44 (0)1223 233 410 
Sponsor: 
GW Pharma Ltd 
Sovereign House 
Vision Park 
Chivers Way 
Histon 
Cambridge CB24 9BZ 
United Kingdom 
Tel: +44 (0) 1223 266 800 
Fax: +44 (0) 1223 235 667 
Medical Advisor & Clinical Project Manager: 
Please refer to the Sponsor and Related 
Contact Details form in the trial site file. 
Clinical Trial Supplies: 
GW Pharma Ltd 
Tel: +44 (0) 1795 435 029 
Fax: +44 (0) 1795 475 439 
Appendix 2.3 
Contract Research Organizations 
At the time of protocol production, the contract research organizations, and the central and 
bioanalytical laboratories for the trial had not been confirmed. A corresponding list will be 
maintained within the GW master files (electronically and added to the trial master file at the 
end of the trial). 
 
 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
Confidential 
Page 93 of 94 
 
Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
Appendix 3 
QUESTIONNAIRES/ASSESSMENTS 
At the time of protocol finalization, questionnaire/assessment licensing has not yet been 
obtained. Copies of the questionnaires/assessments will be made available to all investigators. 
 
 


Study Code: GWSP20105 
SPONSOR: GW PHARMA LIMITED 
EudraCT Number: 2020-003271-18 
GWSP20105_Protocol V1_22Jul2020 
 
Confidential 
Page 94 of 94 
 
Clinical Protocol Template (Phase 2–4) 
V1, 24Sep15 
Appendix 4 
PROHIBITED MEDICATIONS SOLELY 
METABOLIZED BY UGT1A9 AND UGT2B7 
Examples of medications that are solely metabolized by UGT1A9 and UGT2B7 and 
prohibited for the duration of the trial are provided in the sections below. 
Appendix 4.1 
Prohibited Medications Metabolized Solely by UGT1A9 
x Flavopiridol 
x Propofol 
Appendix 4.2 
Prohibited Medications Metabolized Solely by UGT2B7 
x Benoxaprofen 
x Carbamazepine 
x Codeine 
x Cyclosporin A 
x Epirubicin 
x Indomethacin 
x Tacrolimus 
x Tiaprofenic acid 
x Zaltoprofen 
x Zomepirac 
x Zidovudine 

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GW Pharma Limited
Addendum to Statistical Analysis Plan for Protocol GWSP20105 (21Feb2023)
CONFIDENTIAL 
Page 1 of 6
Addendum to Statistical Analysis Plan (SAP)
Protocol Title:
A Randomized, Double-blind, Placebo-controlled, 2-way Crossover 
Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical 
Measures of Spasticity in Patients with Multiple Sclerosis
Study Code:
GWSP20105
Protocol Version No. /Date:
V1.0/22-Jul-2020
CRF Version No. / Date:
V1.0/07-Apr-2021
SAP Version No. / Date:
V1.0 / 08Jun2022
SAP Addendum Version No. / Date
V1.0 / 21Feb2023
Approvals
Author / Title:
 Contract Statistician
Signature / Date:
NA - approved with eSignature
Reviewer 
Biostatistician / Title:
 Associate Director, Biostatistics
Signature / Date:
NA - approved with eSignature
Reviewer
Clinical Development:
 Global Development Lead, Clinical Development, 
Neuroscience
Signature / Date:
NA - approved with eSignature
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GW Pharma Limited
Addendum to Statistical Analysis Plan for Protocol GWSP20105 (21Feb2023)
CONFIDENTIAL 
Page 2 of 6
Change History
Version/Date
Change Log
0.1 / 20Jan2023
Created as new
1.0/01Feb2023
Changes to abbreviations to reflect Jazz style guide, that abbreviations are not defined 
in text (even at first use)
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GW Pharma Limited
Addendum to Statistical Analysis Plan for Protocol GWSP20105 (21Feb2023)
CONFIDENTIAL 
Page 3 of 6
Table of Contents, List of Tables and Figures 
3.1 Table of Contents
Approvals 1
Change History .......................................................................................................................................2
Table of Contents, List of Tables and Figures ........................................................................................3
3.1 Table of Contents................................................................................................................................3
3.2 List of Tables.......................................................................................................................................4
Purpose……………………......................................................................................................................5
Scope……………… ................................................................................................................................5
Introduction .............................................................................................................................................5
Statistical Methods..................................................................................................................................5
Glossary of Abbreviations .......................................................................................................................6
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GW Pharma Limited 
Addendum to Statistical Analysis Plan for Protocol GWSP20105 (21Feb2023) 
CONFIDENTIAL  
Page 4 of 6 
 
3.2 List of Tables 
Table 3.2-1 Strategy for abbreviated reporting ...................................................................... 5 
 
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GW Pharma Limited
Addendum to Statistical Analysis Plan for Protocol GWSP20105 (21Feb2023)
CONFIDENTIAL 
Page 5 of 6
Purpose
This addendum to the SAP describes the reporting and analyses of data collected under Protocol 
GWSP20105 V1.0 dated 22Jul2020 following the early termination of the study.
Scope
This addendum supplements the SAP.
Introduction
This SAP addendum should be read in conjunction with the study protocol V1.0 dated 22Jul2020, CRF 
V1.0 04Jul2021 and SAP V1.0 08Jun2022. 
Final approval of the SAP addendum will occur prior to study unblinding.
The decision was made on 9th November 2022 to discontinue the study and halt any further enrollment of 
patients without the planned number of patients being recruited.  As a result of this, an abbreviation of the 
planned analysis and reporting as detailed in the protocol and SAP will be conducted.
Statistical Methods
The abbreviated reporting will follow the strategy as detailed in Table 3.2-1.
Table 3.2-1 Strategy for abbreviated reporting
Hierarchy
GWSP20105
Primary
LLMT-6
Inferential and descriptive statistics; 
no supplementary, no subgroup 
analyses and no imputations for 
missing data
Secondary
LLMT-4
TEAEs
As established in study SAP to 
support safety assessment of 
Nabiximols as a globally marketed 
product
Vital signs
Labs
ECG
C-SSRS
PK
No processing, analyses, or 
reporting
Exploratory
T25FW
Data cleaning for inclusion in 
listings; no descriptive or inferential 
statistics
NRS spasticity
Daily spasm count
MSSS-88
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GW Pharma Limited
Addendum to Statistical Analysis Plan for Protocol GWSP20105 (21Feb2023)
CONFIDENTIAL 
Page 6 of 6
Glossary of Abbreviations
Glossary of Abbreviations:
CRF
Case report form
SAP
Statistical analysis plan
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