Clinical trial NCT03848832
Conditions: Rett Syndrome RTT
Keywords: Cannabidiol CBD Epidiolex GWP42003-P
Sponsor: Jazz Pharmaceuticals
Start date: 2019-07-29; Completion date: 2021-01-21
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of cannabidiol oral solution (GWP42003-P, CBD-OS) in reducing symptom severity when compared with placebo, in participants with Rett syndrome.

Detailed description:

Arms: arm 1: 100 milligrams per milliliter (mg/mL) GWP42003-P oral solution. Taken twice daily (morning and evening). arm 2: 100 mg/mL GWP42003-P oral solution. Taken twice daily (morning and evening). arm 3: Placebo oral solution (0 mg/mL GWP42003-P) volume matched to 5 mg/kg/day or 15 mg/kg/day GWP42003-P. Taken twice daily (morning and evening).
Interventions: intervention 1: GWP42003-P intervention 2: Placebo
Intervention descriptions: intervention 1: GWP42003-P presented as an oral solution containing cannabidiol intervention 2: Matching placebo oral solution

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 
 
AD-ST-33.06  Effective date: 12-Nov-2020 
Version 2.0   |    30-MAR-2021    |    AD-PR-109.02  Effective date: 17-Aug-2020 
         Page 1 of 50 
Statistical Analysis Plan
Sponsor 
GW Research Ltd 
Protocol Title: 
A 
RANDOMIZED, 
DOUBLE-BLIND, 
PLACEBO-
CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY 
AND SAFETY OF CANNABIDIOL ORAL SOLUTION 
(GWP42003-P, 
CBD-OS) 
IN 
PATIENTS 
WITH 
RETT 
SYNDROME 
Protocol Number: 
GWND18064 
Premier Research PCN: 
GWRE166121 
EudraCT number: 
2018-003370-27 
ClinicalTrials.gov 
identifier 
NCT03848832 
Document Version: 
Final 2.0 
Document Date:  
30-MAR-2021 
Approvals 
Role 
Signatures 
Date(dd-Mmm-yyyy) 
Biostatistician 
Print Name:
Senior Manager, Biostatistics, Premier Research 
 
Sign Name: 
 
 
 
 
 
GW Research Ltd 
Representative 
Print Name:
Senior Manager, Biostatistics 
 
Sign Name: 
 
 
 
 
 
 
	



	



 
Statistical Analysis Plan,  
 
GW Research Ltd 
 
Protocol Number GWND18064  
 
PCN Number GWRE166121 
AD-ST-33.06  Effective date: 12-Nov-2020 
Version 2.0   |    30-MAR-2021    |    AD-PR-109.02  Effective date: 17-Aug-2020 
         Page 2 of 50 
 
Document History 
Version 
Date 
Author 
Description 
Final 1.0 
02FEB2021 
 
Initial Version 
Final 2.0 
30MAR2021 
 
Update to add clarification on: 
- 
Derivation of treatment received 
- 
Imputation of AE dates for time to 
onset/resolution calculation 
- 
Exposure outputs to produce 
- 
AE analysis based on resolution 
- 
Classification of ALT/AST 
- 
ECG triplicates analysis 
 
 
 


 
Statistical Analysis Plan,  
 
GW Research Ltd 
 
Protocol Number GWND18064  
 
PCN Number GWRE166121 
AD-ST-33.06  Effective date: 12-Nov-2020 
Version 2.0   |    30-MAR-2021    |    AD-PR-109.02  Effective date: 17-Aug-2020 
         Page 3 of 50 
 
 
Table of Contents 
Approvals ........................................................................................................................................ 1 
Document History ........................................................................................................................... 2 
Table of Contents ............................................................................................................................ 3 
List of Tables .................................................................................................................................. 5 
1. 
Overview ............................................................................................................................. 7 
2. 
Study Objectives and Endpoints ......................................................................................... 7 
2.1 
Study Objectives ........................................................................................................... 7 
2.1.1 Primary Objective ......................................................................................................... 7 
2.1.2 Secondary Objectives.................................................................................................... 7 
2.1.3 Exploratory Objectives ................................................................................................. 8 
2.2 
Study Endpoints ............................................................................................................ 8 
2.2.1 Efficacy Endpoints ........................................................................................................ 8 
2.2.2 Safety Endpoints ........................................................................................................... 9 
3. 
Overall Study Design and Plan ......................................................................................... 10 
3.1 
Overall Design ............................................................................................................ 10 
3.2 
Sample Size and Power ............................................................................................... 10 
3.3 
Study Population ......................................................................................................... 10 
3.4 
Treatments Administered ............................................................................................ 11 
3.5 
Method of Assigning Subjects to Treatment Groups .................................................. 11 
3.6 
Blinding and Unblinding............................................................................................. 11 
3.7 
Schedule of Assessments ............................................................................................ 11 
4. 
Statistical Analysis and Reporting .................................................................................... 15 
4.1 
Introduction ................................................................................................................. 15 
4.2 
Interim Analysis, Data Review ................................................................................... 15 
4.2.1 Interim analysis ........................................................................................................... 15 
4.2.2 Data review ................................................................................................................. 15 
5. 
Analysis Populations ......................................................................................................... 15 
6. 
General Issues for Statistical Analysis .............................................................................. 16 
6.1 
Statistical Definitions and Algorithms ........................................................................ 16 
6.1.1 Conventions for treatment/visit naming...................................................................... 16 
6.1.2 Baseline ....................................................................................................................... 17 
6.1.3 Last Visit ..................................................................................................................... 17 
6.1.4 Study Periods .............................................................................................................. 17 
6.1.5 Day Numbering ........................................................................................................... 17 
6.1.6 Multiple Comparisons ................................................................................................. 18 


 
Statistical Analysis Plan,  
 
GW Research Ltd 
 
Protocol Number GWND18064  
 
PCN Number GWRE166121 
AD-ST-33.06  Effective date: 12-Nov-2020 
Version 2.0   |    30-MAR-2021    |    AD-PR-109.02  Effective date: 17-Aug-2020 
         Page 4 of 50 
 
6.1.7 Handling of Dropouts or Missing Data ....................................................................... 18 
6.1.8 Pooling of Sites ........................................................................................................... 19 
6.1.9 Derived Variables ....................................................................................................... 19 
6.1.10 Data Adjustments/Handling/Conventions .................................................................. 20 
7. 
Study Patients and Demographics .................................................................................... 20 
7.1 
Disposition of Patients and Withdrawals .................................................................... 20 
7.2 
Protocol Deviations ..................................................................................................... 21 
7.3 
Demographics and Other Baseline Characteristics ..................................................... 21 
7.3.2 Medical and Surgical History and Current Medical Conditions ................................. 22 
7.4 
Exposure and Compliance .......................................................................................... 22 
8. 
Efficacy Analysis .............................................................................................................. 22 
8.1 
Primary Efficacy Endpoint ......................................................................................... 22 
8.2 
Key Secondary Efficacy Endpoint .............................................................................. 23 
8.3 
Other Secondary Efficacy Endpoints .......................................................................... 23 
8.3.1 RSBQ Subscales ......................................................................................................... 23 
8.3.2 Caregiver Global Impression of Severity ................................................................... 23 
8.3.3 MBA-9 ........................................................................................................................ 24 
8.3.4 Children’s Sleep Habit Questionnaire ........................................................................ 24 
8.4 
Exploratory Efficacy Endpoints .................................................................................. 24 
8.4.1 Caregiver Quality of Life Questionnaire .................................................................... 25 
8.4.2 Patient Quality of Life Questionnaire ......................................................................... 26 
8.4.3 Hospital Services Use Questionnaire .......................................................................... 27 
8.4.4 Caregiver Assessment of Rett Symptoms ................................................................... 27 
9. 
Safety and Tolerability Analysis ....................................................................................... 27 
9.1 
Adverse Events ........................................................................................................... 27 
9.2 
Clinical Laboratory Evaluation ................................................................................... 29 
9.2.1 Hematology and Biochemistry ................................................................................... 29 
9.2.2 Urinalysis .................................................................................................................... 30 
9.2.3 Pregnancy Test and Urine THC Screen ...................................................................... 31 
9.2.4 MECP2 ........................................................................................................................ 31 
9.3 
Vital Signs, Other Physical Findings and Other Safety Data ..................................... 31 
9.3.1 Vital Signs ................................................................................................................... 31 
9.3.2 Electrocardiogram ....................................................................................................... 31 
9.3.3 Physical Examination.................................................................................................. 32 
9.3.4 Suicidality Assessment ............................................................................................... 32 
9.3.5 Growth and Development ........................................................................................... 32 
9.3.6 Menstruation ............................................................................................................... 32 


 
Statistical Analysis Plan,  
 
GW Research Ltd 
 
Protocol Number GWND18064  
 
PCN Number GWRE166121 
AD-ST-33.06  Effective date: 12-Nov-2020 
Version 2.0   |    30-MAR-2021    |    AD-PR-109.02  Effective date: 17-Aug-2020 
         Page 5 of 50 
 
9.4 
Other Measures ........................................................................................................... 33 
9.4.1 Concomitant Medication ............................................................................................. 33 
9.4.2 Procedures and Non-Drug Therapies .......................................................................... 33 
9.4.3 Pregnancy Monitoring Form ....................................................................................... 33 
9.4.4 Plasma Concentrations of CBD and its Main Metabolites ......................................... 33 
9.4.5 Blood Levels of Exploratory Biomarkers ................................................................... 34 
9.4.6 Patients Impacted by COVID-19 ................................................................................ 34 
9.5 
Changes in the Conduct of the Trial or Planned Analysis .......................................... 34 
10. 
References ......................................................................................................................... 35 
11. 
Tables, Listings, and Figures ............................................................................................ 36 
11.1 
Planned Table Descriptions ........................................................................................ 36 
11.2 
Planned Listing Descriptions ...................................................................................... 36 
11.3 
Planned Figure ............................................................................................................ 36 
12. 
Tables, Listings, and Listing Shells .................................................................................. 37 
12.1 
Standard Layout for all Tables, Listings, and Figures ................................................ 37 
APPENDIX 1: Abbreviations ....................................................................................................... 38 
APPENDIX 2 
Adverse Events of Special Interest – Abuse Liability based on preferred term 40 
APPENDIX 3 
Ranges for Clinically Significant Changes and Other Defined Flagged Values 
in Vital Signs/ECG ........................................................................................................... 41 
APPENDIX 4 
Toxicity Criteria for Laboratory Parameters ..................................................... 42 
APPENDIX 5 
Scoring the CHQ-PF50 ..................................................................................... 44 
 
List of Tables 
Table 1 Schedule of assessments .................................................................................................. 12 
Table 2 
Study treatments.......................................................................................................... 16 
Table 3 
Study Visits ................................................................................................................. 17 
Table 4 
RSBQ Subscales ......................................................................................................... 23 
Table 5 
CHSQ Subscales ......................................................................................................... 24 
Table 6 
SF-36 Subscales .......................................................................................................... 25 
Table 7 
CHQ-PF50 Health Concepts ....................................................................................... 26 
Table 8 
Ranges for Potentially Clinically Significant Changes in Vital Signs ........................ 41 
Table 9 
Other Defined Flagged Values for Vital Signs ........................................................... 41 
Table 10 Defined Flagged Values for ECG Parameters ............................................................ 41 
Table 11 Toxicity Criteria for Biochemistry Parameters ........................................................... 42 
Table 12 Toxicity Criteria for Hematology Parameters............................................................. 42 


 
Statistical Analysis Plan,  
 
GW Research Ltd 
 
Protocol Number GWND18064  
 
PCN Number GWRE166121 
AD-ST-33.06  Effective date: 12-Nov-2020 
Version 2.0   |    30-MAR-2021    |    AD-PR-109.02  Effective date: 17-Aug-2020 
         Page 6 of 50 
 
Table 13 Scoring of Global Health Item .................................................................................... 44 
Table 14 Scoring of Item 4.1 for Bodily Pain and Discomfort .................................................. 45 
Table 15 Scoring of Item 4.2 for Bodily Pain and Discomfort .................................................. 45 
Table 16 Scoring of Behavior .................................................................................................... 46 
Table 17 Scoring of Global Behavior Item ................................................................................ 46 
Table 18 Scoring of Mental Health ............................................................................................ 46 
Table 19 Scoring of Self Esteem................................................................................................ 47 
Table 20 Scoring of Global Health Perceptions......................................................................... 47 
Table 21 Scoring of Change in Health Item .............................................................................. 48 
Table 22 Scoring of Emotional Impact on Parent ...................................................................... 48 
Table 23 Scoring of Family Cohesion Item ............................................................................... 49 
 


 
Statistical Analysis Plan,  
 
GW Research Ltd 
 
Protocol Number GWND18064  
 
PCN Number GWRE166121 
AD-ST-33.06  Effective date: 12-Nov-2020 
Version 2.0   |    30-MAR-2021    |    AD-PR-109.02  Effective date: 17-Aug-2020 
         Page 7 of 50 
 
1. 
Overview 
This statistical analysis plan (SAP) describes the planned analysis and reporting for GW protocol 
number GWND18064 (A randomized, double-blind, placebo-controlled trial to investigate the 
efficacy and safety of cannabidiol oral solution (GWP42003-P; CBD-OS) in patients with Rett 
syndrome (RTT), dated 07 Jul 2020 version #4.1. Reference materials for this statistical plan 
include the protocol and the accompanying sample data collection documents. Operational aspects 
related to collection and timing of planned clinical assessments are not repeated in this SAP unless 
relevant to the planned analysis. 
The study objectives listed below are according to latest Clinical Study Protocol. The concept of 
statistical analysis has been changed, no inferential analysis will be performed in the study, the 
statistical analysis will be purely descriptive. The reason for this, as described in Section 8.5, is 
that due to potential impact of the COVID-19 pandemic to patients and site personnel the Sponsor 
made the decision to discontinue the trial. 
The structure and content of this SAP provides sufficient detail to meet the requirements identified 
by the Food and Drug Administration (FDA), European Medicines Agency (EMA), and 
International Conference on Harmonization (ICH) of Technical Requirements for Registration of 
Pharmaceuticals for Human Use: Guidance on Statistical Principles in Clinical Trials1.  
The planned analyses identified in this SAP may be included in clinical study reports (CSRs), 
regulatory submissions, or future manuscripts. Also, post-hoc exploratory analyses not necessarily 
identified in this SAP may be performed to further examine study data. Any post-hoc or unplanned, 
exploratory analysis performed will be clearly identified as such in the final CSR. 
The statistical plan described hereafter is an a priori plan. It will be finalized prior to any unblinded 
inferential or descriptive analysis of data pertaining to study GWND18064. 
2. 
Study Objectives and Endpoints 
2.1 
Study Objectives 
2.1.1 
Primary Objective 
The primary objective is to evaluate the efficacy of 15 mg/kg/day GWP42003-P, compared with 
placebo, at the end of 24 weeks’ treatment in reducing symptom severity in patients with RTT 
using the Rett Syndrome Behaviour Questionnaire (RSBQ). 
2.1.2 
Secondary Objectives 
Key Secondary Objective: 
x To evaluate the efficacy of 15 mg/kg/day GWP42003-P, compared with placebo, at the end of 
24 weeks’ treatment in reducing symptom severity in patients with RTT using the Clinical 
Global Impressions - Improvement (CGI-I). 
Other Secondary Objectives: 


 
Statistical Analysis Plan,  
 
GW Research Ltd 
 
Protocol Number GWND18064  
 
PCN Number GWRE166121 
AD-ST-33.06  Effective date: 12-Nov-2020 
Version 2.0   |    30-MAR-2021    |    AD-PR-109.02  Effective date: 17-Aug-2020 
         Page 8 of 50 
 
x To evaluate the efficacy of 5 mg/kg/day GWP42003-P, compared with placebo in: 
o RSBQ 
o CGI-I 
x To evaluate the effect of GWP42003-P, compared with placebo, in other measures of disease 
severity. 
o RSBQ subscales. 
o Clinical Global Impressions - Severity (CGI-S). 
o 9-items Motor Behavioral Assessment (MBA-9). 
o Children’s Sleep Habits Questionnaire (CSHQ). 
x To evaluate the safety of GWP42003-P, compared with placebo, in patients with RTT. 
2.1.3 
Exploratory Objectives 
Exploratory Objectives: 
x To evaluate the effect of GWP42003-P on caregiver and patient quality of life (QoL). 
o 36-item Short Form [SF-36] and Child Health Questionnaire Parent Form 50 [CHQ-
PF50], respectively. 
x To evaluate the effect of GWP42003-P on health utilization. 
o Hospital Services Use Questionnaire. 
x Caregiver assessment of Rett symptoms (symptom diary). 
x To determine the plasma concentrations of cannabidiol (CBD) and its major metabolites with 
the aim of evaluating exposure versus efficacy and safety and collecting data for population 
pharmacokinetic (PK) analysis. 
x To evaluate the effect of GWP42003-P on exploratory biomarkers. 
2.2 
Study Endpoints 
2.2.1 
Efficacy Endpoints 
2.2.1.1 
Primary Efficacy Endpoint 
The primary efficacy endpoint is the RSBQ (total score) for the 15 mg/kg/day GWP42003-P dose 
level compared with placebo at the end of 24 weeks. 
2.2.1.2 
Secondary Efficacy Endpoints 
Key Secondary Endpoint: 
x CGI-I for the 15 mg/kg/day GWP42003-P dose level compared with placebo at the end of 
24 weeks. 
Other Secondary Efficacy Endpoints: 
x To compare 5 mg/kg/day GWP42003-P with placebo using: 
o RSBQ (total score) 
o CGI-I 


 
Statistical Analysis Plan,  
 
GW Research Ltd 
 
Protocol Number GWND18064  
 
PCN Number GWRE166121 
AD-ST-33.06  Effective date: 12-Nov-2020 
Version 2.0   |    30-MAR-2021    |    AD-PR-109.02  Effective date: 17-Aug-2020 
         Page 9 of 50 
 
x To compare 15 mg/kg/day GWP42003-P and 5 mg/kg/day GWP42003-P with placebo 
using: 
o RSBQ subscales. 
o CGI-S. 
o MBA-9. 
o CSHQ. 
2.2.1.3 
Exploratory Efficacy Endpoint(s) 
x To compare 15 mg/kg/day GWP42003-P and 5 mg/kg/day GWP42003-P with placebo for 
the following endpoints: 
o Caregiver QoL questionnaire (SF-36). 
o Patient QoL questionnaire (CHQ-PF50). 
o Hospital Services Use Questionnaire. 
o Caregiver assessment of Rett symptoms (symptom diary).  
o Blood levels of exploratory biomarkers. 
2.2.1.4 
Other Exploratory Endpoint(s) 
o Plasma concentrations of CBD and its main metabolites. 
2.2.2 
Safety Endpoints 
The safety profile of GWP42003-P compared with placebo will be assessed by measuring:  
x Adverse Events (AEs). 
x Clinical laboratory parameters. 
x Vital signs. 
x Physical examination procedures. 
x 12-lead electrocardiogram (ECG). 
x Effects on menstruation cycles. 
x Suicidality. 
x Change in growth and development by measurement of height, weight, serum insulin-like 
growth factor-1 (IGF-1) levels and Tanner Staging (for patients aged ≥ 7 years, or earlier 
if clinically indicated by onset of menarche or other signs of precocious puberty). 


 
Statistical Analysis Plan,  
 
GW Research Ltd 
 
Protocol Number GWND18064  
 
PCN Number GWRE166121 
AD-ST-33.06  Effective date: 12-Nov-2020 
Version 2.0   |    30-MAR-2021    |    AD-PR-109.02  Effective date: 17-Aug-2020 
         Page 10 of 50 
 
3. 
Overall Study Design and Plan 
3.1 
Overall Design 
This multisite trial consists of a double-blind, randomized, placebo-controlled design which will 
compare the efficacy of GWP42003-P versus placebo over a 24-week treatment period.  
Patients will be randomized to receive 5 mg/kg/day GWP42003-P, 15 mg/kg/day GWP42003-P or 
matching volumes of placebo in a 2:2:1:1 ratio.  
Following screening, eligible patients will complete a 2 to 4-week baseline period (patients can be 
randomized as soon as they have completed at least 2 weeks of baseline and all eligibility criteria are 
confirmed [including review of all clinical laboratory results and, if applicable, confirmation of 
MECP2 pathogenic genetic mutation]). All patients entering the trial will be stratified by severity, 
based on their Clinical Severity Scale (CSS) score (either a CSS score within the range of 10–22, or a 
CSS score within the range 23–36). Patients will be randomized and will commence the 24-week 
treatment period, including up to 2- weeks dose escalation. The treatment period ends at Visit 9 (Day 
169), after which patients will commence a 10-day taper period followed by the 4-week follow-up 
period. The 10-day taper period and 4-week follow-up period may not be required for patients 
continuing CBD-OS treatment under a separate protocol.  
If a patient permanently discontinues treatment at any point during the trial, the investigational 
medicinal product (IMP) should be gradually reduced over 10 days (unless inadvisable due to an AE). 
Patients and caregivers will be encouraged to remain in the trial and continue to complete trial 
assessments and visits as per protocol.  
If a patient withdraws from the trial at any point during the trial, they will be required to attend a 
withdrawal visit, if applicable taper the IMP and attend the end of taper visit, and then complete the 4-
week follow-up period. 
3.2 
Sample Size and Power 
252 patients will be randomized to receive 1 of 2 dose levels of GWP42003-P (5 mg/kg/day or 
15 mg/kg/day) or matching placebo (5 mg/kg/day dosing volumes or 15 mg/kg/day dosing 
volumes) on a 2:2:1:1 basis.  The placebo data for the 2 dose groups will be pooled for analysis. 
Pooling of the placebo dose groups will be implemented for efficacy and safety analyses. For 
safety analysis, summaries by placebo dose will also be presented. 
Assuming a common standard deviation of 9.38 and using a 2-sided test at a 0.05 α-level, a total 
sample size of 252 patients (84 patients per active dose group and 42 patients per placebo group) 
will provide 90% power to detect a mean difference of 5 points in change from baseline to Visit 9 
in RSBQ (total score) between 15 mg/kg/day of GWP42003-P and placebo, allowing for 10% 
withdrawals.    
3.3 
Study Population 
Female or male patients aged 2–18 years (inclusive), who weigh at least 10 kg may enter the trial.  
Patients must have a clinical diagnosis of RTT (typical or atypical), defined according to 
RettSearch Consortium criteria. Patients must have a confirmed pathogenic genetic mutation of 
the MECP2 gene. Patients can be enrolled if they qualify for inclusion criteria and if they do not 
meet any exclusion criteria. For complete list of inclusion/exclusion criteria, please consult clinical 
study protocol.  


 
Statistical Analysis Plan,  
 
GW Research Ltd 
 
Protocol Number GWND18064  
 
PCN Number GWRE166121 
AD-ST-33.06  Effective date: 12-Nov-2020 
Version 2.0   |    30-MAR-2021    |    AD-PR-109.02  Effective date: 17-Aug-2020 
         Page 11 of 50 
 
3.4 
Treatments Administered 
The administered treatment is GWP42003-P oral solution or placebo oral solution. Mode of 
administration: to be taken orally twice daily (morning and evening) using the syringe(s) provided, 
preferentially with food i.e., within 30 minutes after the end of a meal and in line with the patients’ 
normal feeding schedule and dietary habits.  The time of IMP administration in relation to food 
should be kept consistent throughout the trial.  Patients will take their first dose of IMP in the clinic 
at the end of Visit 2 (Day 1) and caregivers will be instructed how to measure and administer the 
IMP to the patient.   
Patients will escalate IMP to the target dose level for their dose group over a period of up to 2 
weeks depending on the target dose (e.g., no titration is required to 5 mg/kg/day while titration to 
15 mg/kg/day takes 2 weeks [weekly increments of 5 mg/kg/day]).  Following escalation patients 
will remain at their assigned target dose level for the duration of the maintenance period of the 
trial. 
3.5 
Method of Assigning Subjects to Treatment Groups  
At the start of Visit 1 (screening), enrolled patients will be allocated a unique patient number. After 
completion of assessments and confirmation of eligibility at Visit 2, patients will be randomized 
to receive 5 mg/kg/day GWP42003-P, 15 mg/kg/day GWP42003-P or matching volumes of 
placebo in a 2:2:1:1 ratio. All patients entering the trial will be stratified by severity, based on their 
Clinical Severity Scale (CSS) score (either a CSS score within the range of 10–22, or a CSS score 
within the range 23–36). GW will provide all IMP in a packed and labeled state and the RTSM 
system will identify the pack number(s) to be dispensed to the patient at each relevant visit, 
according to the treatment assigned in the randomization schedule. 
3.6 
Blinding and Unblinding  
The identity of IMP assigned to patients will be held by the RTSM system. The principal 
investigator (PI) at each site, or his/her designee, is responsible for ensuring that information on 
how to access the RTSM system 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 reason will be considered a protocol deviation. 
3.7 
Schedule of Assessments  
A detailed schedule of events for the study is provided in Table 1 .  
 


Statistical Analysis Plan,  
GW Research Ltd 
Protocol Number GWND18064  
PCN Number GWRE166121 
AD-ST-33.06  Effective date: 12-Nov-2020 
Version 2. 30-MAR-2021    |    AD-PR-109.02  Effective date: 17-Aug-2020 
Page 12 of 50 
Table 1 Schedule of assessments 
Visit Number 
1 
2 
3a 
4a 
5 
6 
7 
8 
9b,c 
10d 
11a 
Day Number 
(Visit window) 
−28 to 
−14* 
1 
(+3) 
8 
(± 3) 
15 
(± 3) 
29 
(± 3) 
57 
(± 3) 
85 
(± 3) 
127 
(± 3) 
169 
(± 3) 
179 
(+3) 
207 
(+3) 
Informed consent and assente 
X 
 
 
 
Demographics 
X 
 
 
 
Medical history 
X 
 
 
 
CSS 
X 
 
 
 
Eligibility check 
X 
X 
 
 
Genetic analysis of MECP2 (if unknown)f 
X 
 
 
 
Randomization 
 
X 
 
 
Concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Menstruation question (where appropriate)  
X 
 
X 
 
Physical examination (including weight) 
X 
 
 
X 
X 
X 
 
Height 
X 
 
 
X 
 
ECG 
X 
 
 
X 
X 
X 
X 
X 
 
Vital signs 
X 
X 
 
X 
X 
X 
X 
X 
X 
 
Clinical laboratory blood sampling 
(hematology and biochemistry)g 
X 
 
 
X 
X 
X 
Xh 
X 
 
Dipstick urinalysis (where possible) 
X 
 
 
X 
 
Visit Number 
1 
2 
3a 
4a 
5 
6 
7 
8 
9b,c 
10d 
11a 
Day Number 
(Visit window) 
−28 to 
−14* 
1 
(+3) 
8 
(± 3) 
15 
(± 3) 
29 
(± 3) 
57 
(± 3) 
85 
(± 3) 
127 
(± 3) 
169 
(± 3) 
179 
(+3) 
207 
(+3) 
Urine/Serum THC screeni 
X 
 
 
 
Serum pregnancy test (if appropriate) 
X 
 
 
X 
 
PK blood sampling (IMP) 
 
 
 
Xj,k,l 
Xj,k,l 
Xj,k,l 
Xj,k,l 
 


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Biomarker blood sampling 
X 
 
 
X 
 
Caregiver 
completed 
questionnaire 
RSBQ 
X 
X 
 
X 
X 
X 
X 
X 
 
CSHQ 
 
X 
 
X 
X 
X 
X 
X 
 
Caregiver QoL questionnaire 
(SF-36) 
 
X 
 
X 
 
Patient QoL questionnaire 
(CHQ-PF50) 
 
X 
 
X 
 
Symptom diaryn 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Time and date of last IMP dose 
 
 
 
X 
X 
X 
X 
 
MBA-9 
 
X 
 
X 
X 
 
CGI-S 
 
X 
 
X 
X 
X 
X 
X 
 
CGI-I 
 
 
 
X 
X 
X 
X 
X 
 
  
*Patients can be randomized as soon as they have completed at least 2 weeks of baseline and all eligibility criteria are confirmed (review of clinical laboratory 
results and, if applicable, genetic analysis)  
a Visit to be conducted by telephone. 
b To be performed for all patients completing or withdrawing from the trial. Patients who withdraw early should commence the 10-day IMP taper 
period, if possible. 
c A safety follow-up visit 4 weeks after last IMP dose is required for all patients who withdraw from the trial or complete the trial but do not enroll 
in the OLE. 
d Only required for those patients who do not participate in the OLE trial or for those who withdraw from the trial early and taper IMP. For patients 
Visit Number 
1 
2 
3a 
4a 
5 
6 
7 
8 
9b,c 
10d 
11a 
Day Number 
(Visit window) 
−28 to 
−14* 
1 
(+6) 
8 
(± 
3) 
15 
(± 3) 
29 
(± 
3) 
57 
(± 3) 
85 
(± 3) 
127 
(± 3) 
169 
(± 3) 
179 
(+3) 
207 
(+3) 
Hospital Services Use Questionnaire 
 
X 
 
X 
X 
X 
X 
X 
 
Tanner Staging (where appropriate) 
X 
 
 
X 
 
Suicidality assessment 
X 
 
 
X 
X 
X 
X 
X 
X 
 
IMP dispensingo 
 
X 
 
X 
X 
X 
X 
X 
 
IMP collection and compliance review 
 
 
 
X 
X 
X 
X 
X 
X 
 
Dosing diaryp 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 


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Protocol Number GWND18064  
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who complete treatment but do not participate in the OLE trial, Visit 10 should be 10 (+3) days after Visit 9. For patients who withdraw early and 
taper IMP, this visit should occur 10 (+3) days after the withdrawal visit. 
e Informed consent must be obtained prior to any trial-related procedures. In cases where the patient possesses adequate understanding, assent will 
be taken along with parental/legal representative consent. 
f For patients weighing < 13 kg and without documented pathogenic MECP2 mutation, a blood sample for pathogenic MECP2 genetic mutation 
genetic analysis must be in advance of Visit 1 (following informed consent [and where applicable, patient assent]).  
g Determination of serum IGF-1 levels at Visit 1 and 9 only. IGF-1 laboratory results will remain blinded throughout the trial. 
h For patients taking concomitant valproic acid only. 
i THC screen using urine or serum , may be carried out at the site using a drug of abuse urine dipstick; otherwise a urine or blood sample at Visit 1        
may be analyzed and sent to the central laboratory (note: patient weighing < 12 kg, must not provide a serum sample can be collectedfor THC 
screen at Visit 1 instead; if there are difficulties obtaining sufficient urine for THC testing atVisit 1 , then a blood or urine sample must be collected 
at the site on another day within ± 7 days of Visit 1). 
j To be taken together with the safety laboratory sample collection, as appropriate considering the patient’s weight (patient must weigh ≥ 12 kg). 
k Trough sample at Visit 9 (and preferentially also trough sample at Visits 5, 6 and 7, if possible) i.e., collected 9–18 hours after IMP dose. Caregivers 
should be advised not to administer the IMP prior to attending Visit 9 (and preferentially advised not to administer IMP prior to attending Visits 5, 
6, and 7, if possible). The IMP can then be administered during the visit, once the PK sample has been collected. 
l The time of the patients’ sample collection, time of latest IMP dose, time and type of meal consumed by the patient closest to the latest IMP dose 
will be recorded, as well as the time of latest concomitant medications.For patients weighing < 16 kg, no blood sample will be collected for 
biomarker analysis.  
m Completed weekly throughout the trial. 
n 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. 
o Completed daily throughout the trial. 


 
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4. 
Statistical Analysis and Reporting 
Statistical analyses will be performed after the database is locked. Only after the database has 
been locked will the unblinded statistician make the treatment allocations available.  
4.1 
Introduction 
Data processing, tabulation of descriptive statistics, calculation of inferential statistics, and 
graphical representations will be performed primarily using SAS (release 9.4 or higher). If the use 
of other software is warranted, the final statistical methodology report will detail what software 
was used for what purposes. 
Continuous (quantitative) variable summaries will include the number of patients (n) with 
non-missing values, the number of missing values, mean, standard deviation (SD), median, 
minimum, and maximum, unless otherwise specified.  
Categorical (qualitative) variable summaries will include the frequency and percentage of patients 
who are in the particular category for each possible value. In general, the denominator for the 
percentage calculation will be based upon the total number of patients in the study population for 
the treatment groups, unless otherwise specified.  
The number of missing values will be calculated as difference between the total number of patients 
in the study population for the treatment group and the number of non-missing values.  
The minimum and maximum will be reported with the same degree of precision (i.e. the same 
number of decimal places) as the observed data. Measures of location (mean and median) will be 
reported to 1 degree of precision more than the observed data and measures of spread (SD) will be 
reported to 2 degrees of precision more than the observed data. 
Percentages will be presented to 1 decimal place, unless otherwise specified. 
4.2 
Interim Analysis, Data Review 
4.2.1 
Interim analysis 
No formal interim analysis will be conducted. 
4.2.2 
Data review 
No blinded data review meeting will take place. After database lock, the study will be unblinded 
and descriptive statistical outputs will be created using the unblinded data.  
5. 
Analysis Populations 
The following analysis sets will be used for the statistical analysis:  
Screened 
• 
All patients screened.   


 
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Randomized 
• 
All patients randomized.   
Intent-to treat set (ITT) 
• 
All patients who are randomized, receive at least 1 dose of IMP in the trial, and have 
baseline efficacy data will be included and analyzed according to their randomized 
treatment arm.  
• 
The ITT set is the primary analysis set for all efficacy endpoints.  
Safety Analysis Set  
• 
All patients who receive at least 1 dose of IMP in the trial will be included and analyzed 
according to the treatment received. Only patients for whom it has been confirmed that 
they did not take any IMP will be excluded from this safety analysis set. This analysis set 
will be used to report the safety data. Treatment received will be derived using the real kits 
dispensed (reported in database) as following: 
- 
If patient took only placebo, assign to placebo.  
- 
If patient took mostly placebo but one dose of 5 mg/kg/day (or 15 mg/kg/day) 
then assign to 5 mg/kg/day (or 15 mg/kg/day). 
- 
If patient was assigned to CBD and took CBD then assign them to the dose group 
they were meant to be assigned to. 
Analysis sets will be identified prior to database lock and unblinding of the trial data. 
6. 
General Issues for Statistical Analysis 
All data collected in the study will be listed, ordered by site, treatment, patient number and, 
where applicable, chronological order of the assessment. Visit date is not needed to be included 
in the listings, day numbers will be included where appropriate.  
Other derived variables (e.g. change from baseline values) that are calculated for analysis 
purposes or to aid interpretation of the data will be included in the data listings.  
6.1 
Statistical Definitions and Algorithms 
6.1.1 
Conventions for treatment/visit naming 
In all tables, listings and figures, the treatment arms will be referred to and labelled as per Table 2
 
Study treatments 
Table 2 
Study treatments 
Endpoint 
Actual Treatment 
Treatment Label (Table 
column/Figure legend) 
Sorting order in listings, 
column order in tables 
Efficacy 
Pooled Placebo 
Placebo 
3  
Safety,  
Demographics 
and Baseline 
5 mg/kg/day Placebo 
Placebo 5 mg/kg 
3 
15 mg/kg/day Placebo 
Placebo 15 mg/kg 
4 
Pooled Placebo 
Placebo 
5 
All 
5 mg/kg/day GWP42003-P 
GWP42003-P 5 mg/kg 
1 
All 
15 mg/kg/day GWP42003-P 
GWP42003-P 15 mg/kg 
2 


 
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For safety tables where placebo is split by dosage, an additional Pooled Placebo column will be 
included. 
In all tables, listings and figures, the study visits will be referred to and labelled as per Table 3. 
Table 3 
Study Visits 
Actual Visit 
Visit Label 
Visit 1: Screening 
Screening 
Visit 2: Day 1, baseline visit 
Day 1 
Visit 3: Day 8 
Day 8 
Visit 4: Day 15 
Day 15 
Visit 5: Day 29 
Day 29 
Visit 6: Day 57 
Day 57 
Visit 7: Day 85 
Day 85 
Visit 8: Day 127 
Day 127 
Visit 9: Day 169  
End of Treatment 
Visit 10: Day 179 
End of Taper 
Visit 11: Day 207 
Safety Follow-Up 
No derivation will be used for visits; data will be tabulated and listed according to the visit it was 
recorded under in eCRF. 
6.1.2 
Baseline 
For all efficacy endpoints Visit 2 will be used as the baseline observation for all calculations. The 
baseline value for the symptom diary will be the mean of the symptom diary scores prior to first 
dose.  
For all safety endpoints, the last non-missing observation recorded prior to the first drug 
administration will be used as the baseline observation for all calculations.  
6.1.3 
Last Visit 
The last visit for efficacy endpoints assessed at clinic visits is defined as the last scheduled visit 
at which a patient’s last evaluation (up to Visit 9/end of treatment visit/any other last visit) is 
performed.  
6.1.4 
Study Periods 
Treatment period: Day 1 to Day 169. 
For 15 mg/kg/day group only: 
Titration period: Day 1 to Day 14 
Maintenance period: Day 15 to Day 169. 
6.1.5 
Day Numbering 
The first day of treatment (Day 1) will be the date on the ‘First IMP Dose’ eCRF. 


 
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Any days prior to Day 1 will be numbered relative to this day and calculated as: 
Date − (Date of Day 1) 
to give Day −1, −2, −3 etc. 
Any days post Day 1 will be calculated as:  
1 + Date − (Date of Day 1) 
6.1.6 
Multiple Comparisons 
Multiple comparisons with regards to primary/key secondary/secondary endpoints are detailed in 
Efficacy Analysis section 8.  
6.1.7 
Handling of Dropouts or Missing Data 
Every effort has been made to minimize missing data for this trial.  The patient reported outcomes 
will be completed by the patient’s primary caregiver on electronic devices.  These assessments 
have been set up in such a way that the caregiver cannot proceed to the next question if they have 
not entered a response for the current question.  In addition, on the off chance that the device does 
not function correctly, paper alternatives of the assessments are available.  
6.1.7.1 
Handling of Missing Data for Efficacy Endpoint (Primary, Secondary and 
Exploratory) 
If a questionnaire has subscales then the missing items in a subscale can be imputed as the mean 
of the non-missing items in that subscale, provided that at least half of the items in the subscale 
were answered. If more than half the items in the subscale are missing then the missing items will 
be imputed as LOCF. 
If a questionnaire does not have subscales (eg MBA-9, CSHQ single item scale) the missing 
items will be imputed using LOCF. 
6.1.7.1.1 SF-36 
The SF-36 assessment will be scored by the QualityMetric Health Outcomes Scoring Software 5.0 
(Maruish, 2011) which assumes that the response to a missing item in a particular scale is the same 
as the mean of the responses to the scale’s answered items.  This approach cannot be used to 
estimate item responses on the physical functioning scale due to the hierarchical nature of the items 
included in this scale.  If items on the physical functioning scale are missing, the QualityMetric 
Health Outcomes Scoring Software v5.0 estimates the PF score using item response theory. If any 
SF-36 is logged as completed by an alternative caregiver, it will be counted as missing. 
6.1.7.1.2 CHQ-PF50 
Appendix 5 describes the methods of handling missing data for the CHQ-PF50 health scales. 
6.1.7.1.3 Adverse Events 
Missing and/or incomplete dates for AEs will be imputed in a manner resulting in the earliest onset 
or the longest duration during the treatment period, while ensuring that the start date is not after 
the stop date, i.e. missing start dates will be imputed as the first day of the month/first month of 


 
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the year and missing stop dates will be imputed as the last day of the month/last day of the year, 
while ensuring that the start date is not after the stop date. Upper and lower limits of imputation 
will be date of Visit 2 and date of Visit 9, and events occurring on date of Visit 2 will be assumed 
post-IMP as per Section 6.1.9.1 Stop dates will not be imputed if the AE is ongoing. 
The imputation method will be used to determine treatment emergence and time to onset/resolution 
of an AE, and imputed dates/times will not be presented in AE outputs. 
A worst-case approach will be followed in the event of missing severity or causality data.  If the 
severity is missing, ‘Severe’ will be imputed.  If causality data is missing for a treatment emergent 
AE (TEAE), ‘Yes’ will be imputed for the question ‘Plausible relationship to study medication’. 
6.1.7.1.4 Concomitant Medication 
Missing concomitant medication dates will be handled in a similar fashion as described for AEs 
in Section 6.1.7.1.3. 
6.1.8 
Pooling of Sites 
As there are expected to be relatively few patients per site, the site will not be taken into account 
in the analyses. Therefore the question of pooling of sites does not arise.  
6.1.9 
Derived Variables 
For derivations of the efficacy variables, see Section 8.  The following additional derived and 
computed variables have been initially identified as important for the analyses to be performed for 
this trial.  
In case additional derived variables may be required: the SAP will not be amended for additional 
variables that are not related to the primary or secondary endpoints. Any additional derived or 
computed variables will be identified and documented in the SAS programs that create the analysis 
files. If the SAP is not amended, further derivations related to the primary and secondary endpoints 
will be described in the CSR.  
6.1.9.1 Adverse events 
A TEAE is defined as an AE with a start date on or after the first dose of IMP.  If an AE has a 
partial start date and it is unclear from the partial date (or the stop date) whether the AE started 
prior to or post first dose of IMP then the AE will be considered treatment emergent.  If the start 
date of the AE is the same as the date of first dose of IMP then the AE will be considered treatment 
emergent. 
A TEAE will be considered treatment-related if the plausibility relationship to IMP is recorded on 
the eCRF as ‘yes’.  If the data on plausibility relationship to IMP is missing then the TEAE will 
be considered treatment-related. 
A TEAE will be considered leading to permanent discontinuation of IMP (leading to withdrawal) 
if the action taken with IMP is recorded on the eCRF as ‘trial medication stopped’ or the outcome 
is recorded on the eCRF as ‘patient died’. 
A treatment-related TEAEs leading to withdrawal is a TEAE leading to permanent IMP 


 
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discontinuation and considered treatment-related as per above definition.  
A TEAE will be considered leading to IMP temporary discontinuation if the action taken with IMP 
is recorded on the eCRF as ‘trial medication interrupted’. 
A TEAE will be considered leading to permanent IMP dose reduction excluding permanent 
discontinuation if the action taken with IMP is recorded on the eCRF as ‘dose reduced’. 
An AE will be considered fatal if the outcome is recorded on the eCRF as ‘patient died’. 
The time to first onset of AE will be calculated for TEAEs as: 
Start date of AE – Date of first dose of IMP + 1 
The time to AE resolution will be calculated for TEAEs as: 
Stop date of AE – Start date of AE + 1 
6.1.9.2 Prior and concomitant medications  
Medications that started and stopped prior to the first study drug intake will be considered prior 
medications. A concomitant medication is defined as any medication that was administered during 
the treatment period. This includes medications that started before the treatment period and 
continued while on treatment and medications that started during the treatment period.  
If the start/stop dates of a medication are partially or completely missing, then the medication will 
be assumed to be concomitant if it cannot be definitely shown that it was not administered during 
the treatment period. Missing dates will not be replaced.  
6.1.9.3 Age 
Age will be calculated as: 
(Date of screening – date of birth) ÷ 365.25. 
6.1.9.4 Exposure 
The total number of dosing days in the treatment period will be calculated as: 
(Date of last dose in the treatment period – Date of Day 1) + 1 
6.1.10 Data Adjustments/Handling/Conventions  
All collected data will be presented in listings. Data not subject to analysis according to this plan 
will not appear in any tables or graphs but will be included only in the data listings.  
7. 
Study Patients and Demographics 
7.1 
Disposition of Patients and Withdrawals 
Patient disposition, by site, by country and overall, will be summarized by treatment group and 
overall using standard summary statistics.  The number screened, number of screen failures and 
number randomized will be included. 


 
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A screen failure disposition table will be presented, including number of patients screened, number 
failing screening, number randomized and the reasons for failing screening. 
Patient disposition, including patients treated, patients who completed the treatment period and the 
taper phase, patients entering the OLE, patients discontinued (including reason for discontinuation) 
from the treatment but completed trial, patients that withdrew from trial, and taper phases will be 
summarized by absolute counts (n) and percentages (%).  A further table split by site, and by 
country will be produced, showing number of patients randomized, withdrawn and completed the 
treatment period and entering the OLE at each site or in each country. 
7.2 
Protocol Deviations 
Protocol deviations will be identified and classified. 
Major protocol deviations will be summarized by type of violations for the randomized population. 
Protocol deviations will be listed. Protocol deviations due to COVID-19 will be listed separately. 
7.3 
Demographics and Other Baseline Characteristics 
The following demographic data will be summarized by treatment group and overall for the safety 
and ITT analysis sets: 
• 
Age (years); 
• 
Age group (2-5 years, 6-12 years and 13-18 years); 
• 
Sex; 
• 
Race; 
• 
Ethnicity 
• 
Country; 
• 
Region (United States, Rest of the World); 
• 
Weight at baseline (kg); 
• 
Height at baseline (cm); 
• 
Body mass index at baseline (kg/m2); 
The following baseline characteristics will be summarized by treatment group and overall for the 
safety and ITT analysis sets: 
• 
CSS Score; 
• 
CSS stratum; 
• 
Previous use of cannabis. 
7.3.1.1 
History of RTT 
The following history of RTT data will be summarized by treatment group and overall for the 
safety analysis set: 
• 
Type of diagnosis (Typical, Atypical). 
• 
Main and supportive criteria for RTT diagnosis. 
• 
Age at diagnosis (months) 
• 
Time since last known loss of hand use or verbal language or gross motor regression 
(months). 


 
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• 
Information about the MECP2 mutation (whether a known mutation is documented and if 
available, the type of mutation). 
• 
Communication methods used by the child. 
• 
Types of seizures that are ongoing. 
• 
Status epilepticus. 
• 
Whether the child lives at home or at a care home/institution. 
• 
Most common feeding method. 
• 
Planned method for IMP administration. 
7.3.2 
Medical and Surgical History and Current Medical Conditions 
All conditions and diagnoses on the ‘medical and surgical history’ eCRF page will be coded using 
Version 21.1 of the Medical Dictionary for Regulatory Activities (MedDRA v21.1) or later 
version. 
The number of patients with relevant or significant medical or surgical history and medical history 
by system organ class, and preferred term, will be summarized by absolute counts (n) and 
percentages (%).  Percentages will be calculated based on the number of patients in the specific 
treatment group.  Two tables will be produced, one including any events classified as resolved at 
screening, and the other including all current conditions. 
7.4 
Exposure and Compliance 
IMP is to be administered twice daily (morning and evening).  The first dose will be taken in the 
clinic on Day 1.  The date of final dose in the treatment period will be recorded on the eCRF.  The 
date of final dose, for patients who enter the taper period, will be recorded on the eCRF at the end 
of taper visit.   
For dosing during the treatment period, the following data will be presented: total number of dosing 
days, number of days with diary reported, number of days with doses not taken according to the 
diary will be reported as continuous variables. Number and percentagesof dose adjustments 
(escalation, decrease, other) as well as methods of IMP administration will be described. 
8. 
Efficacy Analysis 
The primary analyses will use the ITT analysis set.  
No formal hypothesis testing will be carried out for this study. Statistical analysis will be 
descriptive.  
8.1 
Primary Efficacy Endpoint 
The RSBQ is a caregiver-completed questionnaire that measures the frequency of current disease 
characteristics (45 items) that may or may not apply to the patient.  Each item is rated on a 3-point 
numerical scale, where all items except for item 31 (“Uses eye gaze to convey feelings, needs and 
wishes”) is scored as follows: 0 indicating an item that is ‘not true as far as you know’, 1 indicating 
an item is ‘somewhat or sometimes true’, and 2 indicating an item that is ‘very true or often true’.   
Item 31 is to be reverse scored, where 0 indicates that this item is ‘very true or often true’, 1 


 
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indicating that this item is ‘somewhat or sometimes true’, and 2 indicating that this item is ‘not 
true as far as you know’. The total maximum score is 90 and higher total scores represent greater 
severity. 
The RSBQ score and its change from baseline will be summarized on a numerical scale by visit 
and treatment group.  
8.2 
Key Secondary Efficacy Endpoint 
The CGI-I is a 7-point scale that requires the clinician to assess how much the patient’s illness has 
improved or worsened relative to a baseline state at the beginning of the intervention. This is rated 
as: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = 
minimally worse; 6 = much worse; or 7 = very much worse. 
The CGI-I score will be summarized on both a categorical scale and a numerical scale by visit and 
treatment group.   
The analyses described above will be performed on the ITT analysis set. 
8.3 
Other Secondary Efficacy Endpoints 
8.3.1 
RSBQ Subscales 
The RSBQ includes 8 subscales: general mood, breathing problems, hand behaviors, face 
movements, body rocking/expressionless face, night-time behaviors, anxiety/fear, and 
walking/standing.  The items included in each subscale are presented in Table 4. 
Table 4 
RSBQ Subscales 
Subscale 
Items Included 
General Mood 
2, 14, 15, 16, 22, 29, 30, 36  
Breathing Problems 
1, 5, 6, 19, 25 
Hand Behaviors 
18, 20, 21, 24, 35, 43 
Face Movements 
4, 28, 32, 34 
Body Rocking/Expressionless Face 
12, 17, 31*, 33, 40, 41 
Night-time Behaviors 
13, 37, 42 
Anxiety/Fear 
7, 9, 10, 38 
Walking/Standing 
23, 39 
* Item 31 is to be reverse scored as described in section 5.5.2. 
The subscale scores are calculated by summing the scores of the items in each subscale. 
Subscale scores and their change from baseline will be summarized by treatment and visit for each 
subscale.  
The analysis will be performed on the ITT analysis set. 
8.3.2 
Caregiver Global Impression of Severity 
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at 
the time of assessment, relative to the clinician’s experience with patients who have the same 
diagnosis. Considering total clinical experience, a patient will be assessed on severity of illness at 


 
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the time of rating. This is rated as: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = 
moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill. 
CGI-S scores and their change from baseline will be summarized by treatment and visit. Frequency 
table will be created for CGIS categories by treatment and visit.  
8.3.3 
MBA-9 
The MBA-9 scale is completed by the investigator and addresses core symptoms of RTT. MBA-9 
was derived from the full MBA scale (37 RTT symptoms) by selecting the items that are deemed 
to be amenable to change and that reflect areas of meaningful clinical change. The severity of 
current symptoms is rated on a 5-point numerical scale; 0 = normal or never; 1 = mild or rare; 2 = 
moderate or occasional; 3 = marked or frequent; 4 = very severe or constant. The MBA-9 score is 
calculated by summing the scores of the individual items.  The maximum score is 36 and higher 
scores represent greater severity. 
MBA-9 scores and their change from baseline will be summarized by treatment and visit.  
8.3.4 
Children’s Sleep Habit Questionnaire 
The CSHQ includes a total sleep disturbance score and 8 sleep subscales: bedtime resistance, sleep 
onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing 
and daytime sleepiness.  The items included in each subscale are presented in Table 5. 
Table 5 
CHSQ Subscales 
Subscale 
Items Included 
Bedtime resistance 
1*, 3*, 4, 5, 6, 8 
Sleep onset delay 
2* 
Sleep duration 
9, 10*, 11* 
Sleep anxiety 
5, 7, 8, 21  
Night wakings 
16, 24, 25 
Parasomnias 
12, 13, 14, 15, 17, 22, 23 
Sleep disordered breathing 
18, 19, 20 
Daytime sleepiness 
26*, 27, 28, 29, 30, 31, 32, 33 
* These items are to be reverse scored. 
The responses to each item of the CSHQ are to be scored as Usually=3, Sometimes=2, Rarely=1, 
except for the items marked with * in Table 5, which are considered to be “desirable” sleep 
behaviors and are therefore reverse scored.  Items 32 and 33 are scored 1 for “not sleepy”, 2 for 
“very sleepy”, 3 for “falls asleep”.  
CSHQ scores and CSHQ subscale scores along with their change from baseline will be 
summarized by treatment and visit.  
8.4 
Exploratory Efficacy Endpoints 
The analysis of exploratory efficacy endpoints will be descriptive, using summaries by treatment 
arms.  


 
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8.4.1 
Caregiver Quality of Life Questionnaire 
The caregiver’s health-related quality of life will be assessed using the 36-item short form (SF-
36). The SF-36 measures 8 domains of health-related quality of life: 1) limitations in physical 
activities because of health problems; 2) limitations in social activities because of physical or 
emotional problems; 3) limitations in usual role activities because of physical health problems; 4) 
bodily pain; 5) general mental health (psychosocial distress and well-being); 6) limitations in usual 
role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health 
perceptions.  These domains are used to calculate 2 composite scores, the physical health 
composite score (PCS) and the mental health composite score (MCS). 
The items included in each subscale are presented in Table 6. 
Table 6 
SF-36 Subscales 
Subscale 
Items Included 
Physical functioning 
3 (a to j) 
Role-physical 
4 (a to d) 
Bodily pain 
7 and 8 
General health 
1 and 11 (a to d) 
Vitality 
9 (a, e, g and i) 
Social functioning 
6 and 10 
Role-emotional 
5 (a to c) 
Mental health 
9 (b, c, d, f and h) 
 
The raw SF-36 data will be sent to Optum via Rave Web Services so that the subscales and 
composite scales can be scored by the QualityMetric Health Outcomes™ Scoring Software 5.0.  
The scores will then be uploaded into the electronic database. 
The scoring of the SF-36 questionnaire via the QualityMetric Health Outcomes™ Scoring 
Software 5.0 is based on norm-based scoring which ensures that the scores for the subscales have 
a mean of 50 and a standard deviation of 10, based on the 2009 US general population (Maruish, 
2011). A higher score is indicative of a better health state. 
The steps that the software follows to score the scales and composite scales are summarized below: 
1. Some of the items are recoded to ensure that a higher score corresponds to a better health 
state for all items in the SF-36. 
2. The raw scores for the health domain scales are calculated as the sum of the final response 
values for the items included in each scale. 
3. Transform the score to a 0-100 scale score: 
Transformed scale score = (Actual raw score - Lowest possible raw score)/Possible raw 
score range x 100 
4. Transform to z-scores ~ Normal(0,1) according to the 2009 US general population norms. 
5. Calculate T scores for each domain = T score = 50 + (domain z-score x 10).  T scores 
calculated to aid interpretation. 
6. Finally calculate MCS and PCS using a 3 step procedure: 
First, the eight health domain scales are standardized using means and standard deviations 


 
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from the 2009 U.S. general population. Second, these standardized scores are aggregated 
using weights (factor score coefficients) from the 1990 U.S. general population. Third, 
aggregate PCS and MCS scores are standardized using a linear Tscore transformation with 
a mean of 50 and a standard deviation of 10. 
SF-36 composite scores and SF-36 subscale scores along with their change from baseline will be 
summarized by treatment and visit.  
8.4.2 
Patient Quality of Life Questionnaire 
This instrument is a well-validated general QoL measure in pediatric populations with chronic 
illness. It measures QoL of the child and the family by parent or child report. The caregiver will 
be asked to complete the questionnaire on behalf of the patient. The CHQ-PF50 covers 
multidimensional health concepts including Physical Functioning, Role/Social Limitations–
Emotional/Behavioral, Role/Social Limitations– Physical, Behavior, Mental Health, Self-Esteem, 
General Health , Bodily Pain, Family Activities, Parent Impact–Time, Parent Impact–Emotional, 
and Family Cohesion. Scores for specific items and subscales, as well as a standardized physical 
summary (PhS) score and a standardized psychosocial summary (PsS) score, can be calculated 
from the CHQ-PF50 questionnaire. Scores are based on a 0 to 100 scale and higher scores indicate 
better quality of life. 
Table 7 presents the items included in each health concept. 
Table 7 
CHQ-PF50 Health Concepts 
Health Concept 
Items Included 
Global health item 
1.1 
Physical functioning 
2.1 (a to f) 
Role/social limitations due to emotional/behavioral difficulties 
3.1 (a to c) 
Role/social limitations due to physical health 
3.2 (a to b) 
Bodily pain and discomfort 
4.1 and 4.2 
Behavior  
5.1 (a to e) and 5.2 
Global behavior item 
5.2 
Mental health 
6.1 (a to e) 
Self esteem 
7.1 (a to f) 
General health perceptions 
8.1 (a to e) and 1.1 
Change in health item 
8.2 
Emotional impact on parent 
9.1 (a to c) 
Time impact on parent 
9.2 (a to c) 
Family activities 
9.3 (a to f) 
Family cohesion item 
9.4 
 
Details regarding the scoring of the health concepts of CHQ-PF50 and of the PhS and PsS can be 
found in Appendix 5.  All of the health concepts and scales included in CHQ-PF50, except for the 
change in health item are continuous. 
CHQ-PF50 standardized scores (as per Appendix 5) CHQ-PF50 subscale scores, PhS and PsS 
scores along with their change from baseline will be summarized by treatment and visit.  


 
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8.4.3 
Hospital Services Use Questionnaire 
The Hospital Services Use Questionnaire captures the frequency of hospital visits and patient 
hospitalizations.  The responses to this questionnaire will be summarized by treatment group for 
the baseline and treatment periods. 
8.4.4 
Caregiver Assessment of Rett Symptoms 
The Caregiver Assessment of Rett Symptoms is a symptom diary, including 12 items, each scored 
between 0 and 10, where a higher score for all items except items 1 and 9 represents a greater 
severity.  Items 1 and 9 will be reverse-scored and a total score will be calculated as the sum of 
items 1 to 10, 11a and 12a. For items 11 and 12, if 11 is ‘No’ then 11a should be scored 10 and if 
12 is ‘No’ then 12a should be scored 0.  A visit score will be derived for each item and for the total 
score as the mean of the scores since the previous visit. 
The total scores and the scores for each item of the Caregiver Assessment of Rett Symptoms along 
with change from baseline will be summarized by visit and treatment group.  
9. 
Safety and Tolerability Analysis 
9.1 
Adverse Events 
All reported AEs will be classified by system organ class (SOC), preferred term and lower level 
term using Version 21.1 of MedDRA or higher.  
Summaries will be presented by treatment group as well as SOC and preferred term. 
The following summaries will be generated (counts are by patient unless specified otherwise): 
Overall summary of AEs, including number of patients reporting each of; Treatment Emergent 
Adverse Events (TEAEs), TEAEs that started during the titration period as applicable, treatment-
related TEAEs, treatment-related TEAEs that started during the titration period, TEAEs leading to 
withdrawal, treatment-related TEAEs leading to withdrawal, serious TEAEs, treatment-related 
serious TEAEs. 
• 
Summary of TEAEs. 
• 
Summary of TEAEs by event (PT). 
• 
Summary of treatment-related TEAEs. 
• 
Summary of treatment-related TEAEs by event 
• 
Summary of TEAEs by maximal severity. 
• 
Summary of TEAEs by sex. 
• 
Summary of serious TEAEs. 
• 
Summary of serious TEAEs by event. 
• 
Summary of non-serious TEAEs. 
• 
Summary of non-serious TEAEs by event (PT). 
• 
Summary of treatment-related serious TEAEs. 
• 
Summary of treatment-related serious TEAEs by event (PT). 
• 
Summary of TEAEs leading to permanent discontinuation of IMP. 
• 
Summary of treatment-related TEAEs leading to permanent discontinuation of IMP. 


 
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• 
Summary of TEAEs leading to IMP dose reduction excluding permanent discontinuation 
(by resolution and overall). 
• 
Summary of treatment-related TEAEs leading to IMP dose reduction excluding permanent 
discontinuation (by resolution and overall). 
• 
Summary of TEAEs leading to temporary IMP dose reduction (by resolution and overall). 
• 
Summary of treatment-related TEAEs leading to temporary IMP dose reduction (by 
resolution and overall). 
• 
Summary of TEAEs leading to permanent IMP dose reduction excluding permanent 
discontinuation (by resolution and overall). 
• 
Summary of treatment-related TEAEs leading to permanent IMP dose reduction excluding 
permanent discontinuation (by resolution and overall). 
• 
Summary of fatal TEAEs. 
• 
Summary of TEAEs by time of first onset of AE. 
• 
Summary of TEAEs by time to AE resolution. 
• 
Summary of TEAEs reported in ≥ 2% of patients (after rounding) in the GWP42003-P 
treatment groups and where the incidence is greater than the (pooled) placebo treatment 
group. 
• 
List of patients experiencing TEAEs by SOC and preferred term. 
• 
Summary of pre-treatment AEs. 
For the summary of TEAEs by maximal severity, for each patient, the worst severity recorded by 
preferred term, SOC and overall will be used for summary purposes.  If severity is missing, the 
worst case (severe) will be assumed. 
For summaries by resolution, AEs with an outcome of ‘recovered’ or ‘recovered with sequelae’ 
will be summarized as ‘Resolved’ and AEs with an outcome of ‘continuing’, ‘patient died’ or those 
with a missing outcome will be summarized as ‘Continuing’. For each patient, preferred term and 
SOC, if both ‘Resolved’ and ‘Continuing’ AE are present in database, only the ‘Continuing’ one 
will be presented in outputs. 
For the summary of TEAEs by time of first onset of AE, data will be summarized under the 
following categories: 
• 
Week 1 (Day 1–7). 
• 
Week 2 (Day 8–14).  
• 
Weeks 3–6 (Day 15–42). 
• 
Weeks 7–10 (Day 43–70). 
• 
Weeks 11–14 (Day 71–98). 
• 
Weeks 15–18 (Day 99–126). 
• 
Weeks 19–22 (Day127–154). 
• 
>22 weeks (> Day 154). 
If patients have multiple occurrences of an AE then the AE will be counted once for the first 
occurrence only.  Percentages will be based on the number of patients in the safety analysis set 
who have a visit or follow-up call within each time period above.In case there is no planned visits 
in the interval, percentages will be based on the number of patients in the safety analysis set. 


 
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For the summary of TEAEs by time to AE resolution, data will be summarized under the following 
categories: 
• 
1 week (≤7 days). 
• 
2 weeks (8–14 days). 
• 
3 weeks (15–21 days). 
• 
4 weeks (22–28 days). 
• 
>4 weeks (>28 days). 
• 
Ongoing (for AEs not resolved). 
If patients have multiple occurrences of an AE then the AE will be counted once for the occurrence 
with the longest time to AE resolution.  However, if any of the AEs are not resolved then the AE 
will be counted once within the ‘Ongoing’ category. 
The start and stop day of the AE relative to the first dose of IMP (as recorded on the eCRF) will 
be calculated as per Section 6.1.56.1.5.  For partial dates, if it is clear from the partial date that the 
start/stop day was prior to the first dose of IMP, then ‘pre’ will be listed, similarly if it is clear that 
the event was post the first dose of IMP then ‘post’ will be listed as the start/stop day as appropriate. 
If it is not clear whether it is pre or post first dose of IMP, then day is not calculated, field is left 
blank. 
All AEs will be listed.  Listings will include the start and stop day of the AE, a flag for treatment 
emergence, and limited demographic information about the patient (age, sex, race and weight at 
screening).  A separate listing will be provided for pre-treatment AEs, serious AEs and events of 
special interest (see APPENDIX Appendix 2). 
9.2 
Clinical Laboratory Evaluation 
9.2.1 
Hematology and Biochemistry 
Hematology and biochemistry safety parameters are measured at Visit 1 (screening), Visit 5, Visit 
6, Visit 7, Visit 8 (for patients taking valproic acid only) and Visit 9 (end of treatment). 
Summaries will be presented by treatment group for each laboratory parameter at each visit.  
Change from baseline and percent change from baseline to each post-baseline visit will also be 
presented. 
If values for any of the parameters are below or above the limit of quantification of the assay (BLQ 
or ALQ), then they will be included in the summary tables at the BLQ or ALQ thresholds.   
Where laboratory samples are repeated, the baseline value is defined as the final recorded value 
prior to the first dose of IMP.   
Shift tables for hematology and biochemistry parameters will be produced, based upon normal 
ranges and GW toxicity limits (See Appendix 4), to determine the categorical shifts from baseline 
to each post-baseline visit.  Values will be categorized as ‘Normal’, ‘Low’ or ‘High’ based on 
normal ranges and ‘Toxically Low’, ‘Toxically Normal’ or ‘Toxically High’ based on GW toxicity 
limits. 


 
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For eGFR, results will be assigned to the following grades: 
• 
Normal: >60 ml/min/1.73 m2 
• 
Grade 1: 60 ml/min/1.73 m2 
• 
Grade 2: ≥30 and <60 ml/min/1.73 m2 
• 
Grade 3: ≥15 and <30 ml/min/1.73 m2 
• 
Grade 4:  <15 ml/min/1.73 m2 
A separate shift table will be produced for eGFR based upon the above grades to determine the 
categorical shifts from baseline to each post-baseline visit. 
An additional table will be produced, summarizing the number of patients meeting the following 
criteria:  
• 
Alanine aminotransferase (ALT) > 1×ULN at baseline 
• 
Aspartate aminotransferase (AST) > 1×ULN at baseline 
• 
AT > 1×ULN at baseline 
• 
Treatment-emergent ALT > 3×ULN, > 5×ULN and > 8×ULN 
• 
Treatment-emergent AST > 3×ULN, > 5×ULN and > 8×ULN 
• 
Treatment-emergent AT > 3×ULN, > 5×ULN and > 8×ULN 
• 
Treatment-emergent AT > 3×ULN and either bilirubin > 2×ULN or INR > 1.5 
where AT is AST or ALT, and treatment emergent is defined as criteria not met at baseline, but 
met at any time post-baseline.  For each of these parameters, a patient with value > 8 ULN will 
also fall into the >3 and >5 ULN categories. 
The above will be summarized overall and for the following subgroups:  
• 
Valproic acid use (as a concomitant medication) (Yes, No).  
• 
Clobazam use (as a concomitant medication) (Yes, No).  
• 
Valproic acid use and Clobazam use (as concomitant medications) (Yes/Yes, Yes/No, 
No/Yes, No/No).  
(A medication will be considered concomitant if it has a start date on or after the first dose 
of IMP or if it was started prior to the first dose of IMP and was ongoing.) 
• 
Patients taking 3 or more current AEDs.  
• 
Patients taking 4 or more current AEDs.  
All laboratory data will be listed; listings will include limited demographic information about the 
patient (age, sex, race and weight at baseline).  Abnormal laboratory values will be listed 
separately.  A further listing will be created for the laboratory reference ranges and toxicity limits.  
A listing of liver parameters (ALT, AST, bilirubin and INR) will be produced that includes the 
baseline result, result at the particular visit, change from baseline, upper limit of normal (ULN) 
value, ratio of result to baseline and ratio of result to ULN. 
9.2.2 
Urinalysis 
Urinalysis is assessed, using dipsticks, at the same visits as biochemistry and hematology. 
Urinalysis results will be listed only. 


 
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9.2.3 
Pregnancy Test and Urine THC Screen 
Serum pregnancy test results and urine THC screen results will be summarized by treatment group 
and visit. 
9.2.4 
MECP2 
Results from the MECP2 genetic mutation assessment at screening will be listed, along with 
demographic data in one listing. The listing will indicate whether the MECP2 genetic mutation 
was known at screening or whether it was obtained from laboratory results. 
9.3 
Vital Signs, Other Physical Findings and Other Safety Data 
9.3.1 
Vital Signs 
Vital signs (systolic blood pressure, diastolic blood pressure and pulse rate) are measured at Visit 
1 (screening), Visit 2 (Day 1), Visit 5, Visit 6, Visit 7, Visit 8, Visit 9 (end of treatment) and Visit 
10 (end of taper). 
Summaries will be presented by treatment group for each vital sign parameter at each visit.  Change 
from baseline to each post-baseline visit will also be presented. 
A separate table will be produced, by treatment group and visit, presenting the incidence of patients 
with vital signs indicative of a medical condition at Visit 1 and indicative of an AE after Visit 1. 
Based on the criteria presented in Appendix 3, potentially clinically significant changes from 
baseline in vital signs measurements and other defined flagged values will be identified at each 
visit.  The number of patients with a potentially clinically significant change from baseline will be 
summarized by parameter, visit and treatment group.  The number of patients with at least one 
post-baseline flagged vital sign parameter value will be summarized by parameter, flagged criteria 
and treatment group. 
9.3.2 
Electrocardiogram 
An ECG will be performed at Visit 1 (screening), Visit 5, Visit 6, Visit 7, Visit 8 and Visit 9 (end 
of treatment). 
For each visit, ECG parameters are measured 3 times (5 minutes interval). For statistical analysis, 
the mean of those values will be taken into account. 
Summaries will be presented by treatment group for mean heart rate, RR interval, PR interval, 
QRS duration, QT interval, QTcB and QTcF, at each visit.  Change from baseline to each 
post-baseline visit will also be presented. 
A separate table will be produced, by treatment group and visit, presenting the incidence of patients  
Based on the criteria presented in Appendix 3, defined flagged values will be identified at each 
visit.  The number of patients with at least one post-baseline flagged ECG parameter value will be 
summarized by parameter, flagged criteria and treatment group. 


 
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9.3.3 
Physical Examination 
A physical examination which includes body weight measurements will be performed at Visit 1 
(screening), Visit 5, Visit 7 and Visit 9 (end of treatment).  Height will be collected as part of the 
physical examination at Visit 1 (screening) and Visit 9 (end of treatment).  If an accurate 
measurement of height is not possible an estimate will be provided. 
Any relevant findings at screening are included as part of the patient’s medical history.  Any 
changes seen after screening that are indicative of an AE are to be recorded as such on the AE 
form and included as part of the AE summaries. 
Weight along with weight change and height data will be summarized by visit.  
9.3.4 
Suicidality Assessment 
The profound cognitive impairment of RTT patients is such that the Children’s Columbia-Suicide 
Severity Rating Scale is not considered appropriate in this trial. Instead, suicidality will be assessed 
by the investigator via a clinical interview with the caregiver. 
Responses to the suicidality assessment will be summarized by visit and treatment group. 
9.3.5 
Growth and Development 
IGF-1 levels will be analyzed as part of the clinical laboratory testing.  IGF-1 levels will be 
summarized on a continuous scale, including change from baseline, by treatment group. 
Change from baseline to the end of treatment visit for IGF-1 levels will also be plotted against the 
Tanner Stages, weight, and height recorded at baseline. 
The pubic hair growth (both sexes), genital (males only) and breast (females only) development 
of all adolescent patients (i.e., > 7 years of age at the time of signing the informed consent form, 
or earlier if clinically indicated by onset of menarche or other signs of precocious puberty) will be 
assessed using Tanner Staging.  The assessment can either be performed by examination during 
the study visit or the appropriate Tanner Stage can be indicated by the caregiver, with reference to 
the chart provided. 
Patients will be examined at Visit 1 (screening) and Visit 9 (end of treatment).  Once a patient 
reaches a score of V (i.e., 5) the examination need not be performed again. 
Tanner Stages will be summarized on a categorical scale, by treatment group. Shift table will be 
created to display shifts from baseline.  
9.3.6 
Menstruation 
Caregivers will be asked if the female patient is menstruating and details will be recorded at 
Visit 1; any changes in normal cycles will be captured at Visit 9 (end of treatment). 
Menstruation details will be summarized as appropriate, including any changes in normal cycles 
at the end of treatment, by treatment group. 


 
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9.4 
Other Measures 
9.4.1 
Concomitant Medication 
Medications will be coded using the World Health Organization Drug Dictionary, Version B3 
September 2018 or later version. 
A medication will be considered concomitant if it has a start date on or after the first dose of IMP 
or if it was started prior to the first dose of IMP and was ongoing.  If a medication has a partial or 
missing start/stop date and it is unclear from the date whether the medication was taken after the 
first dose of IMP then it will be considered concomitant. 
For summaries and listings of medications the following approach will be used to determine the 
Anatomical Therapeutic Chemical (ATC) term to be presented: 
• 
If coded to level 4 then the level 4 coded term will be presented. 
• 
If coding is not performed at level 4 but level 3 coding is present then level 3 coded term 
will be presented. 
• 
If coding is not performed at level 3 but level 2 coding is present then the level 2 coded 
term will be presented. 
• 
If coding is not performed at level 2 but level 1 coding is present then the level 1 coded 
term will be presented. 
Concomitant medications by ATC term and preferred term will be summarized by absolute counts 
(n) and percentages (%). 
The ATC term, preferred term, reported generic name and reported brand name will be listed. 
The start day and stop day will be included in the listing according to Section 6.1.5.  If the date is 
partial and the exact day is unknown then the text ‘pre’ or ‘post’ will replace the start or stop day 
if it is clear from the partial date that the medication started or stopped prior to or after the first 
dose of IMP. If pre/post determination is not clear, Day will be left blank.  
9.4.2 
Procedures and Non-Drug Therapies 
Procedures and non-drug therapies will be summarized by treatment group. 
9.4.3 
Pregnancy Monitoring Form 
Any patient who has become pregnant whilst receiving IMP, or within 90 days of last dose of IMP, 
must be reported to the GW PVD. Where possible the investigator should provide the outcome of 
the pregnancy and complete the pregnancy monitoring form.  Details of pregnancies will be listed. 
9.4.4 
Plasma Concentrations of CBD and its Main Metabolites 
The plasma concentrations of CBD and its main metabolites will be assessed at Visits 5, 6, 7 and 
9 (if possible and as appropriate considering the patients weight, patient must weigh at least 12 
kg). One trough PK blood sample will be taken at Visit 9 i.e., the sample must be collected before 
the patient’s next dose, 12 hours (−3/+6 hours) since last IMP dose. Visits where PK samples are 
taken will preferentially be scheduled for a time that allows collection of a trough PK sample, 


 
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whenever possible. The IMP can then be administered during the visit, once the PK sample has 
been collected.  
Plasma concentrations of CBD and its main metabolites 7-hydroxy-CBD (7-OH-CBD) and 7-
carboxy-CBD (7-COOH-CBD) will be summarized by visit and GWP42003-P arm, showing the 
number of non-missing values (n), arithmetic mean, standard deviation, coefficient of variation 
(%), median, minimum and maximum. Where samples are reported as BLQ, a value of zero will 
be used in the summaries. Summary statistics will be presented to 3 significant figures. Summaries 
by dosing method (oral/G tube) will be presented. 
Plasma concentration summaries may exclude individual visits for patients deemed to meet certain 
criteria that could affect exposure. These criteria (identified in BDRM) include:  
x Patients vomiting on or 1 day prior to the PK visit.  
x Missed doses prior to the PK visit.  
x IMP dose reduction.  
x Cases of severe diarrhoea.  
x Use of disallowed concomitant medication.  
All data will be listed. Concentrations excluded from summaries will be flagged along with the 
reason for exclusion. 
Patient meal times and details regarding the type of meal (snack, standard meal, high fat meal), 
and information on latest concomitant medicationwill be recorded at Visit 5, Visit 6, Visit 7 and 
Visit 9 (end of treatment).  Meal and latest medication data will be listed only.Blood Levels of 
Exploratory Biomarkers 
Biomarkers (e.g. IGF-1) and their change from baseline will be summarized by visit and 
treatment. 
9.4.6 
Patients Impacted by COVID-19  
A listing of all patients impacted by COVID-19 related study disruption will be provided. The 
listing will include patient ID, site and a description of how the patient’s participation was 
altered.  
Protocol Deviations related to COVID will be provided in a data listing.  
9.5 
Changes in the Conduct of the Trial or Planned Analysis 
After carefully evaluating the study performance and the potential impact of the COVID-19 
pandemic to patients and site personnel the Sponsor made the decision to discontinue the trial. The 
significant challenges to conducting studies in this vulnerable group of patients were magnified by 
the COVID-19 pandemic leading to the conclusion that it was no longer feasible to conduct this 
study. As a result the analyses described in this SAP differ from those that were initially intended 
and presented in the protocol. 
 
 


 
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10. 
References 
1. US Federal Register. (1998) International Conference on Harmonization; Guidance on 
Statistical Principles for Clinical Trials. Department of Health and Human Services: Food and 
Drug Administration [Docket No. 97D-0174]. Federal Register Volume 63, Number 179, 
pages 49583-49598. September 16, 1998. 
 
2. ASA. (2016) Ethical Guidelines for Statistical Practice. Prepared by the Committee on 
Professional Ethics, April 2016. http://www.amstat.org/about/ethicalguidelines.cfm 
3. RSS. 
(2014) 
The 
Royal 
Statistical 
Society: 
Code 
of 
Conduct, 
2014. 
http://www.rss.org.uk/Images/PDF/join-us/RSS-Code-of-Conduct-2014.pdf. 
4. HealthActCHQ. (2013). The CHQ Scoring and Interpretation Manual. Boston, MA: 
HealthActCHQ. 
5. Maruish, M. (2011). User's manual for the SF-36v2 Health Survey (3rd ed.). Lincoln, RI: 
QualityMetric Incorporated. 
6. Rubin, D. (1987). Multiple imputation for nonresponse in surveys. New York: John Wiley & 
Sons. 
 
 


 
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Protocol Number GWND18064  
 
PCN Number GWRE166121 
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11. 
Tables, Listings, and Figures 
All listings, tables, and graphs will have a header showing the sponsor company name and protocol 
and a footer showing the version of SAS, the file name and path, and the source of the data (eCRF 
page or listing number). 
11.1 
Planned Table Descriptions 
Planned summary tables for protocol GWND18064 are fully detailed in the corresponding 
documentation on GWND 18064 TFL shells. Tables will be numbered according to the 
nomenclature used to support the clinical study report (CSR) according to sponsor’s template. 
11.2 
Planned Listing Descriptions 
Planned data and patient/patient data listings for protocol 4.1 are detailed in GW 18064 TFL shells 
document.  Data listings will be numbered according to the nomenclature used to support the CSR 
when the Premier Research CSR template is used. However, the listing numbering structure can 
be modified per the sponsor’s request to meet compatibility with the sponsor’s CSR template. 
In general, one listing will be produced per eCRF domain. All listings will be sorted by treatment, 
site, and patient number. All calculated variables will be included in the listings. 
In all listings a blank line will be placed between each patient. Within a data listing, if an item 
appears line after line (eg, repetition of patient number), then only the first occurrence will be 
displayed. 
In data listings, the information for one patient will be kept on one page if at all possible, rather 
than splitting a patient’s information across pages. 
11.3 
Planned Figure  
Planned figures for protocol 4.1 are detailed in GW 18064 TFL shells document. 
 
 


 
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12. 
Tables, Listings, and Listing Shells 
12.1 
Standard Layout for all Tables, Listings, and Figures 
Table and listing shells are provided as a separate document. The final statistical tables will be 
produced in the format of the shells and will additionally include “double” page numbering in the 
format “page xx of yy”. Note that programming notes may be added or modified if appropriate 
after each TLF shell.  
The final statistical output will be provided as fully bookmarked pdf file including a table of 
contents. 
No shells are provided for figures. 
 
 


 
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Protocol Number GWND18064  
 
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APPENDIX 1: Abbreviations 
Abbreviation 
Definition 
AE 
Adverse event 
CRO 
Contract research organization 
CSR 
Clinical study report 
D 
Day 
eCRF 
Electronical case report form 
ITT 
Intent-to –treat analysis set 
ECG 
Electrocardiogram 
EMA 
European Medicines aAgency 
FDA 
Food and Drug Administration 
ICH 
International Conference on Harmonisation 
MedDRA 
Medical ictionary for regulatory activities 
PD 
Pharmacodynamics 
PP 
Per-protocol population 
PK 
Pharmacokinetics 
QTc 
QT-interval for ECG corrected for heart rate 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SD 
Standard deviation 
SAF 
Safety population 


 
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Abbreviation 
Definition 
SOC 
System organ class 
TEAE 
Treatment-emergent adverse event 
WHO 
World Health Organization 


 
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APPENDIX 2 Adverse Events of Special Interest – Abuse Liability based on preferred term 
Withdrawal 
Drug withdrawal convulsions 
Drug withdrawal headache 
Drug withdrawal maintenance therapy 
Drug withdrawal syndrome 
Drug withdrawal syndrome neonatal 
Drug rehabilitation 
Rebound effect 
Steroid withdrawal syndrome 
Withdrawal arrhythmia 
Withdrawal syndrome 
Drug abuse and dependence 
Dopamine dysregulation syndrome 
Drug abuse 
Drug abuser 
Drug dependence 
Drug dependence, antepartum 
Drug dependence, postpartum 
Intentional drug misuse 
Intentional overdose 
Maternal use of illicit drugs 
Neonatal complications of substance abuse 
Polysubstance dependence 
Substance abuse 
Substance abuser 
Accidental overdose 
Dependence 
Disturbance in social behaviour 
Drug administered at inappropriate site 
Drug detoxification 
Drug diversion 
Drug level above therapeutic 
Drug level increased 
Drug screen 
Drug screen positive 
Drug tolerance 
Drug tolerance decreased 
Drug tolerance increased 
Medication overuse headache 
Narcotic bowel syndrome 
Needle track marks 
Overdose 
Prescribed overdose 
Prescription form tampering 
Substance use 
Substance-induced mood disorder 
Substance-induced psychotic disorder 
Toxicity to various agents 
 
 
 


 
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APPENDIX 3 Ranges for Clinically Significant Changes and Other Defined Flagged Values 
in Vital Signs/ECG 
The range of values that will be used to identify clinically significant changes in vital signs 
parameters (See Section 9.3.1) are presented in Table 8. 
For all classification below, a patient can fall in several categories for the same parameter (for 
example a patient with Diastolic BP > 100 will also be counted under Diastolic BP > 90). 
Table 8 
Ranges for Potentially Clinically Significant Changes in Vital Signs 
Vital Sign 
Range 
Sitting Systolic BP (mmHg) 
Change: < -20, > 20 
Sitting Diastolic BP 
(mmHg) 
Change: < -10, > 10 
Pulse Rate (bpm) 
Change: < -10, > 10 
Weight (kg) 
Percent Change: ≤ -7, ≥ 7 
 
Defined flagged values that will be used to identify low or high vital signs parameters (See 
Section 9.3.1) are presented in Table 9. 
 
Table 9 
Other Defined Flagged Values for Vital Signs 
Vital Sign 
Flag 
Sitting Systolic BP (mmHg) 
< 90, > 140, > 160 
Sitting Diastolic BP 
(mmHg) 
< 50, > 90, > 100 
Pulse Rate (bpm) 
< 60, > 100 
Temperature (°C) 
> 38.0, < 36.0 
Respiratory Rate 
(breaths/min) 
< 12, > 20 
 
Defined Flagged Values in ECG Parameters 
Defined flagged values that will be used to identify low or high ECG parameters (See Section 
9.3.2) are presented in Table 10. 
 
Table 10 
Defined Flagged Values for ECG Parameters 
ECG Parameter 
Flag 
QTc (ms) 
> 450, > 480, > 500 
 
 
 


 
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APPENDIX 4 Toxicity Criteria for Laboratory Parameters 
The toxicity criteria that will be used to identify abnormal laboratory parameters are presented in 
Table 11 and Table 12. 
Table 11 
Toxicity Criteria for Biochemistry Parameters 
Parameter 
Toxicity Decrease 
Toxicity Increase 
Chloride 
d0.96xLL 
t1.04xUL 
Calcium 
d0.89xLL 
t1.16xUL 
Sodium 
d0.96xLL 
t1.04xUL 
Potassium 
d0.90xLL 
t1.10xUL 
Glucose (mmol/L) 
d3.2 
t16 
Phosphate 
d0.79xLL 
 
Cholesterol 
d0.85xLL 
t1.6xUL 
AST 
 
t3xUL 
ALT 
 
t3xUL 
Lactate Dehydrogenase 
 
t2.6xUL 
Alkaline phosphatase 
 
t2xUL 
Gamma GT 
 
t2.6xUL 
Bilirubin 
 
>2xUL 
Albumin 
d0.84xLL 
 
Total protein 
d0.84xLL 
t1.16xUL 
Urea 
 
t2.6xUL 
Blood urea nitrogen 
 
t2.6xUL 
Creatinine 
 
t2.6xUL 
Uric acid 
 
t1.16xUL 
UL = upper limit of reference range 
LL = lower limit of reference range 
 
Table 12 
Toxicity Criteria for Hematology Parameters 
Parameter 
Toxicity Decrease 
Toxicity Increase 
Hemoglobin (g/dL) 
d9.4 
 
Hematocrit (%) 
d28 
 
Red cell count 
d0.84xLL 
 
Mean corpuscular volume 
d0.84xLL 
t1.11xUL 
Mean corpuscular hemoglobin 
d0.84xLL 
 
Mean corpuscular hemoglobin concentration 
d0.84xLL 
 
Platelets (x10^9/L) 
d74 
 
Prothrombin time 
 
>1.5xUL 
Prothrombin international normalized ratio 
 
>1.5 
Total white blood cell count (x10^9/L) 
d2.9 
t21 
Total neutrophil count (x10^9/L) 
d1.36 
t14.7 
Segmented neutrophil count (x10^9/L) 
d0.75 
t12.3 
Eosinophils (x10^9/L) 
 
t1.5 
Basophils (x10^9/L) 
 
t0.31 


 
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Parameter 
Toxicity Decrease 
Toxicity Increase 
Monocytes (x10^9/L) 
 
t2.1 
Lymphocytes (x10^9/L) for patients <18 years 
(auto hematology) 
d1.0 
 
Lymphocytes (x10^9/L) for patients <18 years 
(manual hematology) 
d0.2 
 
Lymphocytes (x10^9/L) for patients ≥18 years 
d0.2 
 
UL = upper limit of reference range 
LL = lower limit of reference range 


 
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APPENDIX 5 Scoring the CHQ-PF50 
The CHQ-PF50 provides information on various health concepts, as well as the PhS and PsS 
scales.  Details for scoring each of these concepts and scales are based on the CHQ scoring and 
interpretation manual (HealthActCHQ, 2013).  
Global Health Item 
The global health item (item 1.1) of the CHQ-PF50 is calculated using the steps below. 
1. The scores for this item are recoded as presented below, where missing scores remain 
missing. 
Table 13 
Scoring of Global Health Item 
Response 
Precoded Item Values 
Final Item Values 
Excellent 
1 
5 
Very Good 
2 
4.4 
Good 
3 
3.4 
Fair 
4 
2.2 
Poor 
5 
1 
2. The final scores are then transformed so that they range from 0 to 100 in the following 
way: 
(Final item value – 1) / 4 × 100 
Physical Function 
Items 2.1 (a to f) are included in this health concept.  Each item is coded with a value from 1 to 
4, where 1 corresponds to a response “Yes, limited a lot”, 2 “Yes, limited some”, 3 “Yes, limited 
a little“ and d 4 corresponds to the response “No, not limited”. 
The score for the physical function health concept is calculated using the following steps: 
1. The mean of the scores (raw score) for items 2.1 (a to f) is calculated if at least 3 of the 
items have been answered.  If less than 3 items have responses this concept is set to missing. 
2. The standardized score which ranges from 0 to 100 is then calculated as follows: 
(Raw score – 1) / 3 × 100 
Role/Social Limitations Due to Emotional or Behavioral Difficulties 
This health concept is based on items 3.1 (a to c).  Each item is coded with a value from 1 to 4, 
where 1 corresponds to a response “Yes, limited a lot” and 4 corresponds to the response “No, 
not limited”. 
The steps below are followed to score this health concept 
1. If at least 2 of the 3 items have been answered, the mean of the scores (the raw score) for 
items 3.1 (a to c) is calculated, otherwise this concept is set to missing. 
2. The standardized score which ranges from 0 to 100 is then calculated as follows: 
(Raw score – 1) / 3 × 100 
Role/Social Limitations Due to Physical Health 
Items 3.2 (a and b) are included in this health concept.  Each item is coded with a value from 1 to 


 
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4, where 1 corresponds to a response “Yes, limited a lot” and 4 corresponds to the response “No, 
not limited”. 
The steps below are followed to score this health concept 
1. The raw score is calculated as the mean of the scoresif at least 1 of the items has been 
answered, otherwise this concept is set to missing. 
2. The standardized score which ranges from 0 to 100 is then calculated as follows: 
(Raw score – 1) / 3 × 100 
Bodily Pain and Discomfort 
The Bodily Pain and Discomfort scale includes items 4.1 and 4.2.  The scores for these items are 
to be reversed as presented in Table 14 and Table 15. 
Table 14 
Scoring of Item 4.1 for Bodily Pain and Discomfort 
Item 4.1 Response 
Precoded Item Values 
Final Item Values 
None  
1 
6 
Very mild 
2 
5 
Mild 
3 
4 
Moderate 
4 
3 
Severe 
5 
2 
Very severe 
6 
1 
Table 15 
Scoring of Item 4.2 for Bodily Pain and Discomfort 
Item 4.2 Response 
Precoded Item Values 
Final Item Values 
None of the time 
1 
6 
Once or twice 
2 
5 
A few times 
3 
4 
Fairly often 
4 
3 
Very often 
5 
2 
Every/almost every day 
6 
1 
 
The Bodily Pain and Discomfort scale score is then calculated as follows: 
1. The mean of the two scores (the raw score) is calculated if at least one of the items has 
been answered. 
2. The standardized score which ranges from 0 to 100 is then calculated as follows: 
(Raw score – 1) / 5 × 100 
Behavior 
Items 5.1 (a to e) and 5.2 are included in this health concept.  Items 5.1 (a to e) are coded with a 
value from 1 to 5, where 1 corresponds to a response “Very often”, 2 to “Fairly often”, 3 to 
“Sometimes”, 4 to “Almost never”, and 5 corresponds to the response “Never”.  
Responses to item 5.2 are recoded using the rules in Table 16. 


 
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Table 16 
Scoring of Behavior 
Response 
Precoded Item Values 
Final Item Values 
Excellent 
1 
5 
Very Good 
2 
4.4 
Good 
3 
3.4 
Fair 
4 
2.2 
Poor 
5 
1 
 
The following steps are then used to calculate the Behavior concept score: 
1. If at least 3 items have been answered the mean is calculated, otherwise this scale is set to 
missing. 
2. The resulting mean, or raw score, is then standardized to range from 0 to 100 as follows: 
(Raw score – 1) / 4 × 100 
Global Behavior Item 
The global behavior item (item 5.2) of the CHQ-PF50 is calculated using the steps below. 
1. The scores for this item are recoded as presented below, where missing scores remain 
missing. 
Table 17 
Scoring of Global Behavior Item 
Response 
Precoded Item Values 
Final Item Values 
Excellent 
1 
5 
Very Good 
2 
4.4 
Good 
3 
3.4 
Fair 
4 
2.2 
Poor 
5 
1 
2. The final score is then transformed to range from 0 to 100 in the following way: 
(Final item value – 1) / 4 × 100 
Mental Health 
Items 6.1 (a to e) are included in this health concept.  Each of the items 6.1 (a to d) is coded with 
a value from 1 to 5, where 1 corresponds to a response of “All of the time” and 5 corresponds to 
the response “None of the time”.  Responses to item 6.1 (e) are reverse scored as indicated in 
Table 18. 
Table 18 
Scoring of Mental Health 
Response 
Precoded Item Values 
Final Item Values 
All of the time 
1 
5 
Most of the time 
2 
4 
Some of the time 
3 
3 
A little of the time 
4 
2 
None of the time 
5 
1 
 
If at least 3 of the items 6.1 (a to e) have been answered the raw score is obtained by calculating 
the mean of the scores.  The raw score is then standardized to range from 0 to 100 as follows: 


 
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(Raw score – 1) / 4 × 100 
Self Esteem 
The self esteem scale includes Items 7.1 (a to f) which are reverse scored as presented in Table 
19. 
Table 19 
Scoring of Self Esteem 
Response 
Precoded Item Values 
Final Item Values 
Very satisfied 
1 
5 
Somewhat satisfied 
2 
4 
Neither satisfied nor 
dissatisfied 
3 
3 
Somewhat dissatisfied 
4 
2 
Very dissatisfied 
5 
1 
 
If at least 3 of the items 7.1 (a to f) have been answered the mean of the scores is calculated.  The 
mean score is then standardized to range from 0 to 100 as follows: 
(Raw score – 1) / 4 × 100 
General Health Perceptions 
Items 8.1 (a to e) and item 1.1 are included in this scale.  Items 8.1 (a, c, e) are scored from 1 to 5 
where 1 represents the response “Definitely true” and 5 represents “Definitely False”.  Items 8.1 
(b and d) are reverse scored as is seen in Table 20. 
Table 20 
Scoring of Global Health Perceptions 
Response 
Precoded Item Values 
Final Item Values 
Definitely true 
1 
5 
Mostly true 
2 
4 
Don’t know 
3 
3 
Mostly false 
4 
2 
Definitely false 
5 
1 
 
Finally, responses to item 1.1 are recoded as presented in Table 13. 
The general health perceptions scale is then scored using the steps below: 
1. If less than 3 of the items 8.1 (a to e) and 1.1 have been answered, this scale is set to 
missing.  Otherwise calculate the raw score by computing the mean of the responses. 
2. The raw score is then standardized so that it ranges from 0 to 100 as follows: 
(Raw score – 1) / 4 × 100 
 
Change in Health Item 
The change in health item (item 8.2) of the CHQ-PF50 is to be reverse scored as displayed in 
Table 21. 


 
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Table 21 
Scoring of Change in Health Item 
Response 
Precoded Item Values 
Final Item Values 
Much better now than 1 year ago 
1 
5 
Somewhat better now than 1 year ago 
2 
4 
About the same now than 1 year ago 
3 
3 
Somewhat worse now than 1 year ago 
4 
2 
Much worse now than 1 year ago 
5 
1 
This is a categorical scale and thus no transformation is necessary. 
Emotional Impact on Parent 
This scale includes items 9.1 (a to c) which are to be reverse scored in accordance with Table 22. 
Table 22 
Scoring of Emotional Impact on Parent 
Response 
Precoded Item Values 
Final Item Values 
Not at all 
1 
5 
A little bit 
2 
4 
Some 
3 
3 
Quite a bit 
4 
2 
A lot 
5 
1 
 
The emotional impact on parent scale score is then calculated as follows: 
1. If at least 2 of the items in this scale have been answered, the raw score is obtained by 
computing the mean of the responses, otherwise this scale is set to missing. 
2. The raw score is then standardized so that it ranges from 0 to 100 as follows: 
(Raw score – 1) / 4 × 100 
Time Impact on Parent 
Items 9.2 (a to c) are included in the time impact on parent scale.  The responses range from 1 to 
4 where 1 corresponds to “Yes, limited a lot” and 4 corresponds to a response of “No, not 
limited”.  If at least 2 items in this scale have been answered the raw score is calculated as the 
mean of the items.  If less than 2 items have been answered the scale is set to missing. 
Finally, the standardized score which ranges from 0 to 100 is calculated as  
(Raw score – 1) / 3 × 100 
Family Activities 
The family activities health concept is comprised of items 9.3 (a to f).  The responses range from 
1 to 5 where 1 represents the response “Very often” and 5 the response of “Never”.  If at least 3 
items in this scale the raw score is calculated as the mean of the responses, otherwise the scale is 
sent to missing.   
The raw score is then standardized as: 
(Raw score – 1) / 4 × 100 
 


 
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Family Cohesion Item 
The family cohesion health concept includes item 9.4 which is recoded using the rules outlined 
inTable 23. 
Table 23 
Scoring of Family Cohesion Item 
Response 
Precoded Item Values 
Final Item Values 
Excellent 
1 
5 
Very good 
2 
4.4 
Good 
3 
3.4 
Fair 
4 
2.2 
Poor 
5 
1 
The score is then transformed so that it ranges from 0 to 100 as follows: 
(Raw score – 1) / 4 × 100 
 
Standardized Physical Summary and Standardized Psychosocial Summary 
The PhS and PsS scales are scored using norm-based methods based on data from from the 
general U.S. population and six clinical samples of children. Table 24 includes the sample means 
and standard deviations, as well as factor score coefficients, used to derive the PhS and PsS scale 
scores. 
 
Table 24 
Information Required for Scoring PhS and PsS Scales 
 


 
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The steps used in calculating PsS and PhS are summarized below: 
1. Calculate each of the CHQ-PF50 scales presented in Table and using the methods outlined 
in this appendix. 
2. Each scale is then standardized using a z-score transformation as follows: 
ݏ݈ܿܽ݁ ݏܿ݋ݎ݁−݉݁ܽ݊ ݋݂ ݏ݈ܿܽ݁
ݏݐ݀ ݀݁ݒ݅ܽݐ݅݋݊ ݋݂ ݏ݈ܿܽ݁
 
 
where the mean and standard deviation for each scale are obtained from Table 24 
3. Calculate PhS and PsS as a weighted sum of each standardized scale, using the factor score 
coefficients from Table 24 as the weights for each item in each scale. 
4. Transform each scale score to obtain t-score with a mean of 50 and standard deviation of 
10 as follows: 
PhS = PhS weighted sum × 10 + 50 
PhS = PhS weighted sum × 10 + 50.