GWPCARE5: An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes

• Sponsor: Jazz Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02224573
• Collaborator: (none)
• Enrollment: 681
• Arm: 1
• Actual Duration (Months): 63.5

Study Details

Study Description

Brief Summary

To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut syndromes.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy; Dravet Syndrome; Lennox-Gastaut Syndrome	Drug: GWP42003-P	Phase 3

Detailed Description

This is a multi-center, open-label extension study for participants with Dravet syndrome or Lennox-Gastaut syndrome who have previously participated in double-blind, placebo-controlled clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], GWEP1424 [NCT02224703], and GWEP1423 [NCT02224690]). The first participant was enrolled into the open-label extension study after the Data Safety Monitoring Committee reviewed the safety data from Part A of study GWEP1332.

Study Design

• Study Type: Interventional
• Actual Enrollment: 681 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Extension Study to Investigate the Safety of Cannabidiol (GWP42003-P; CBD) in Children and Adults With Inadequately Controlled Dravet or Lennox-Gastaut Syndromes.
• Actual Study Start Date: Jun 11, 2015
• Actual Primary Completion Date: Sep 24, 2020
• Actual Study Completion Date: Sep 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GWP42003-P	Drug: GWP42003-P; Other Names: Cannabidiol CBD Epidiolex/Epidyolex®

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group [up to Week 260]

   TEAEs, defined as AEs that started, or worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, are reported. Any AEs that continued from the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) were only classified as treatment emergent if they worsened in this study.

2. Number of Participants With Clinically Significant Changes in the Indicated Vital Sign Values From the Pre-randomization Baseline of the Core Study at Any Time Post-dose [up to Week 260]

   Clinical significance was determined by the investigator. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. bpm = beats per minute; DBP = Diastolic Blood Pressure; mmHg = millimeters of mercury; SBP = Systolic Blood Pressure. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

3. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Body Mass Index (BMI) [up to Week 260]

   BMI is an estimate of body fat based on body weight divided by height squared. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

4. Number of Participants With Clinically Significant Electrocardiogram (ECG) Values at the Pre-randomization Baseline of the Core Study and at Any Time Post-dose [up to Week 260]

   Clinical significance was determined by the investigator. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. msec = milliseconds; QTcB = corrected QT interval with Bazett's correction. The time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

5. Number of Participants With the Indicated Responses to Questions Regarding Suicidal Ideation and Behavior Using the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 1 and at Any Time Post-dose [up to Week 260]

   The C-SSRS questionnaire is a brief, standardized measure that uniquely assesses the essential information (behavior, ideation, lethality, and severity) and distinguishes between suicidal occurrences and non-suicidal self-injury.

6. Mean Cannabis Withdrawal Scale Score at End of Taper (EOT), the Post-Taper Safety Call, and at Safety Follow-up [up to Week 260]

   The Cannabis Withdrawal Scale is a 19-item scale administered to participants (18 years and above), with each item (withdrawal symptom) measured on a 0 to 10 numerical rating scale (0 = Not at all; 5 = Moderately; 10 = Extremely). Total score, calculated as the sum of the 19 item sub-scores ranging from 0-190 are reported. Higher scores indicate more withdrawal symptoms and an increased negative impact to quality of life. The participant or participant's caregiver was asked to record the extent to which each withdrawal symptom was experienced in the last 24 hours and also to rate the negative impact on normal daily activities. L24S = Last 24 Hours Score; NIS = Negative Impact on Normal Daily Activity Score. The End of Treatment visit occurred after a maximum of 260 weeks of treatment. The End of Taper occurred up to 10 days after the End of Treatment visit. The Safety Call and Safety Follow-up occurred 2 and 4 weeks, respectively, after the End of Taper.

7. Mean Pediatric Cannabinoid Withdrawal Scale (PCWS) Score at the End of Treatment, the End of Taper, the Post-Taper Safety Call, and at Safety Follow-up [up to Week 260]

   The PCWS was administered to participants aged 4 to 17 (inclusive) that was developed from the 19-item validated CWS (adults) to assess mood, behavioral, and physical symptoms associated with cannabis. The total score, calculated as the sum of 10 items (rated on a 4-point scale: 0 = none; 1 = a little bit; 2 = quite a bit; 3 = a lot) ranging from 0-30 are reported. Higher scores indicate more withdrawal symptoms and an increased negative impact to quality of life. The End of Treatment visit occurred after a maximum of 260 weeks of treatment. The participant or participant's caregiver was asked to record the extent to which each withdrawal symptom was experienced in the last 24 hours and also to rate the negative impact on normal daily activities. The End of Taper occurred up to 10 days after the End of Treatment visit. The Safety Call and Safety Follow-up occurred 2 and 4 weeks, respectively, after the End of Taper.

8. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Red Blood Cells (RBCs) Values [up to Week 260]

   Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

9. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Hemoglobin Levels [up to Week 260]

   Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

10. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Hematocrit Values [up to Week 260]

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

11. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Erythrocyte Mean Corpuscular Volume [up to Week 260]

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

12. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Erythrocyte Mean Corpuscular Hemoglobin [up to Week 260]

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

13. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Platelets, White Blood Cells, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils [up to Week 260]

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

14. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils in White Blood Cells (WBCs) [up to Week 260]

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

15. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Sodium, Potassium, Blood Urea Nitrogen, Glucose, Calcium, and High-Density Lipoprotein (HDL) Cholesterol [up to week 260]

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

16. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Creatinine (Jaffe), Creatinine (Enzymatic), and Bilirubin [up to Week 260]

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

17. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Creatinine Clearance (Schwartz) and Creatinine Clearance (Cockcroft-Gault) [up to Week 260]

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. mL/min/1.73 m^2 = millilitres per minute per 1.73 meters squared. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

18. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, and Gamma Glutamyl Transferase [up to Week 260]

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

19. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Albumin and Protein [up to Week 260]

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

20. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prolactin [up to Week 260]

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

21. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prothrombin Time [up to Week 260]

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

22. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prothrombin International Normalized Ratio [up to Week 260]

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

23. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Insulin-like Growth Factor-1 (IGF-1) Levels [up to Week 260]

    IGF-1 levels in serum were analyzed as part of the clinical laboratory testing in participants. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

24. Mean Subject/Caregiver Global Impression of Change (S/CGIC) Score [Baseline; up to Week 260]

    The S/CGIC allows participants and caregivers to rate the participant's overall condition on a scale of 1 to 7 (1 = Very Much Improved, and 7 = Very Much Worse). The combined caregiver and participant summary used either the caregiver or participant version if only one version was completed, or the caregiver version when both the caregiver and participant versions were completed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

25. Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Total Seizure Frequency [Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, Week 253 to 264, and Last 12 Weeks]

    Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver. Change from Baseline was calculated as the percentage change from Baseline for each 12-week period. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. "Last 12 weeks" is equal to the last 12 weeks' data for each participant irrespective of time in study.

26. Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Drop Seizure Frequency in Participants With Lennox-Gastaut Syndrome [Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, and Last 12 Weeks]

    Drop seizures are defined as the subset of tonic-clonic, tonic, or atonic seizures. Change from Baseline was calculated as the percentage change from Baseline for each 12-week period. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. The outcome was reported for Lennox-Gastaut Syndrome participants only. "Last 12 weeks" is equal to the last 12 weeks' data for each participant irrespective of time in study.

27. Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Convulsive Seizure Frequency in Participants With Dravet Syndrome [Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, Week 253 to 264, and Last 12 Weeks]

    Convulsive seizures are defined as tonic-clonic, tonic, clonic, or atonic seizures. Change from Baseline was calculated as the percentage change from Baseline for each 12-week period. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. The outcome was reported for Dravet Syndrome participants only. "Last 12 weeks" is equal to the last 12 weeks' data for each participant irrespective of time in study.

28. Number of Participants With Convulsive and Non-convulsive Seizures Greater Than 30 Minutes in Duration (Status Epilepticus) [Baseline; At last 12 weeks]

    Status epilepticus is defined as any seizure lasting for 30 minutes or longer. The number of convulsive seizures greater than 30 minutes in duration and the number of non-convulsive seizures greater than 30 minutes in duration were collected weekly. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. mins = minutes. "Last 12 weeks" is equal to the last 12 weeks' data for each participant irrespective of time in study.

Secondary Outcome Measures

1. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Quality of Life in Childhood Epilepsy (QOLCE) Scores [Baseline; up to Week 260]

   The QOLCE is a parent-reported questionnaire that evaluates health-related QOL in children aged 2-18 years old. It contains 76 items with 16 subscales covering 7 domains (physical activities, social activities, cognition, emotional well-being, behavior, general health, and general QOL). All items in the questionnaire are rated on a 5-point or 6-point categorical scale. Based on the responses to the items in each domain, scores for 16 subscales are derived. Score range from 0 to 100. Higher score indicate highest level of functioning. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study is defined as the Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

2. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment QOL in Epilepsy Scores (QOLIE-31-P) in Participants With Lennox-Gastaut Syndrome [Baseline; up to Week 260]

   The QOLIE-31-P is a survey of health-related QOL for adults with epilepsy. It is comprised of 38 questions about health daily activities and evaluates how much distress the participant feels about problems and worries related to epilepsy. The questionnaire consists of 7 subscales (energy, mood, daily activities, cognition, medication effects, seizure worry, and overall QOL). Scores range from 0 to 100. Higher scores indicate better QOL. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. The outcome was reported for Lennox-Gastaut Syndrome participants only.

3. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores [Baseline; up to Week 260]

   The Vineland-II is an individually administered instrument for assessing adaptive behaviors. It consists of 4 adaptive behavior domains (1 = low; 5 = high) and a maladaptive behavior domain (1 = clinically significant; 3 = average), and an overall Adaptive Behavior Composite Score. Standard scores (population mean = 100, SD = 15, range = 20 to 160) are produced for the domain and composite scores, and scaled scores (called v-scale scores, with a population mean = 15, SD = 3, range = 1 to 24) are produced for the subscale scores. Higher scores indicate better functioning. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

4. Number of Participants With Inpatient Hospitalizations Due to Epilepsy Since the Previous Visit [Week 48, 104, 156, 208, and End of Treatment (up to Week 260 based on when the participant discontinued treatment)]

   Inpatient hospitalizations due to epilepsy were recorded by the investigator. The timing of the "End of Treatment" varied per participant based on when the participant discontinued IMP.

5. Number of Treatment Responders With Greater Than or Equal to 50% Reduction in Total Seizures [Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, Week 253 to 264, and Last 12 Weeks]

   Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver.

6. Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) [Up to Week 260]

   The SGICSD and CGICSD are comprised of the following questions rated on a 3-point scale for each seizure type. The CGICSD score is used to assess the average duration of the participant's seizures (comparing their condition now to their condition before treatment) and the SGICSD score is used to assess the average duration of seizures (comparing condition now to condition before treatment). Scores range from 1 to 3 (1 = Decrease in average duration; 3 = Increase in average duration).

7. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Delis-Kaplan Executive Function System (D-KEFS) Visual Scanning Completion Time Scaled Score [Baseline; up to Week 260]

   D-KEFS Visual Scanning Completion Time Scale was used to measure visual attention and processing speed. The cognitive assessment battery items are age-specific, used to measure a variety of functions for both children and adults. The items were administered by an experienced psychometrician to a sub-group of sites that had the expertise to conduct the test. The raw score i.e., total time in seconds for completing the visual scanning trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to convert into a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better functioning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in cognitive function.

8. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Number Sequencing Completion Time Scaled Score [Baseline; up to Week 260]

   D-KEFS Number Sequencing Completion Time Scale was used to measure processing speed. The raw score i.e., total time in seconds for completing the number sequencing trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to convert into a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

9. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Letter Sequencing Completion Time Scaled Score [Baseline; up to Week 260]

   D-KEFS Letter Sequencing Completion Time Scaled was used to measure processing speed. The raw score i.e., total time in seconds for completing the letter sequencing trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

10. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Number-letter Switching Completion Time Scaled Score [Baseline; up to Week 260]

    D-KEFS Number-letter Switching Completion Time Scale was used to measure cognitive flexibility, task-set switching, and general executive functioning. The raw score i.e., total time in seconds for completing the number-letter switching trial was measured in the range of 0-240; higher scores indicated worse functioning. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better functioning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in cognitive function. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

11. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Motor Speed Completion Time Scaled Score [Baseline; up to Week 260]

    D-KEFS Motor Speed Completion Time Scale was used to measure motor speed. The raw score i.e., total time in seconds for completing the motor speed trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better motor speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in motor speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

12. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Both Hands Z Score) [Baseline; up to Week 260]

    Purdue Pegboard test was used to measure fine motor dexterity of both hands. The raw score was calculated as the total number of pegs in 30 seconds; higher scores indicated higher level of motor dexterity. The raw score was converted to a Z-score ranging from 0-19; higher scores indicate a higher level of motor dexterity. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as Z-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in motor dexterity. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

13. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Dominant Hand Z Score) [Baseline; up to Week 260]

    Purdue Pegboard test was used to measure fine motor dexterity of the dominant hand. The raw score was calculated as the total number of pegs in 30 seconds; higher scores indicated higher level of motor dexterity. The raw score was converted to a Z-score ranging from 0-19; higher scores indicate a higher level of motor dexterity. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as Z-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in motor dexterity. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

14. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Non Dominant Hand Z Score) [Baseline; up to Week 260]

    Purdue Pegboard test was used to measure fine motor dexterity of the non dominant hand. The raw score was calculated as the total number of pegs in 30 seconds; higher scores indicated higher level of motor dexterity. The raw score was converted to a Z-score ranging from 0-19; higher scores indicate a higher level of motor dexterity. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as Z-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in motor dexterity. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

15. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Adult Intelligence Scale (WAIS) Coding Scaled Score [Baseline; up to Week 260]

    WAIS Coding Scale was used to measure processing speed. The raw score i.e., sum of correct substitutions was measured in the range of 0-16. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

16. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Backward Scaled Score [Baseline; up to Week 260]

    WAIS Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured in the range of 0-16. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

17. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Forward Scaled Score [Baseline; up to Week 260]

    WAIS Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured in the range of 0-16. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

18. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Backward Scaled Score [Baseline; up to Week 260]

    WAIS Longest Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured in the range of 2-8. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

19. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Forward Scaled Score [Baseline; up to Week 260]

    WAIS Longest Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured in the range of 2-8. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

20. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Abbreviated Scale of Intelligence (WASI)-II Vocabulary T Score [Baseline; up to Week 260]

    WAIS-II Vocabulary T Score was used to estimate general intellectual ability based on fund of information and verbal intelligence. The raw score i.e., the sum of correct responses was converted to a T-score ranging from 20-80 using the WASI assessment manual; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of intelligence. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in intelligence. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

21. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WASI-II Matrix Reasoning T Score [Baseline; up to Week 260]

    WASI-II Matrix Reasoning T Score was used to estimate general intellectual ability based abstract reasoning. The raw score i.e., the sum of correct responses was converted to a T-score ranging from 20-80 using the WASI assessment manual; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of abstract reasoning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in abstract reasoning. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

22. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Intelligence Scale for Children (WISC) Coding Scaled Score [Baseline; up to Week 260]

    WISC Coding Scale was used to measure processing speed in children aged 6-16 years 11 months, with scores ranging from 0 to 119. Higher scores indicate better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

23. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Digit Span Backward Scaled Score [Baseline; up to Week 260]

    WISC Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured on a scale of 0-18; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

24. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Digit Span Forward Scaled Score [Baseline; up to Week 260]

    WISC Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured on a scale of 0-18; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

25. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Longest Digit Span Backward Scaled Score [Baseline; up to Week 260]

    WISC Longest Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured on a scale of 2-8; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

26. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Longest Digit Span Forward Scaled Score [Baseline; up to Week 260]

    WISC Longest Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured on a scale of 2-10; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

27. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Preschool & Primary Scale of Intelligence (WPPSI)-IV Bug Search T Score [Baseline; up to Week 260]

    WPPSI-IV Bug Search T Score was used to measure processing speed and complex attention. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 20-80; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of attention. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in attention. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

28. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WPPSI-IV Receptive Vocabulary T Score [Baseline; up to Week 260]

    WPPSI-IV Receptive Vocabulary T Score was used to measure fund of information. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 20-80; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of intelligence. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in intelligence. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

29. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WPPSI-IV Matrix Reasoning T Score [Baseline; up to Week 260]

    WPPSI-IV Matrix Reasoning T Score was used to measure abstract reasoning. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 20-80; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of abstract reasoning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in abstract reasoning. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

30. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Expressive One-Word Picture Vocabulary Test (EOWPVT) Scaled Score [Baseline; up to Week 260]

    Expressive One-Word Picture Vocabulary Test-4th edition was used to test vocabulary. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 0-83; T-scores are standard scores with a mean of 100 and a standard deviation of 15. Higher scores indicate a higher level of language performance. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in language performance. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

31. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in a Developmental NEuroPSYchological Assessment (NEPSY)-2 Word Generation Scaled Score [Baseline; up to Week 260]

    Developmental NEuroPSYchological Assessment (NEPSY)-2 Word Generation Scale was used to measure verbal fluency. The raw score i.e., the sum of correct responses was converted to a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicate a higher level of verbal fluency. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in verbal fluency. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

32. Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Visual Perception Standard Scaled Score [Baseline; up to Week 260]

    Visual Perception Standard scale was used to measure visual motor functioning. The raw score i.e., the sum of the correct responses was measured on a 6-standard score range. Score range of 70-79 indicated "low," 80-89 indicated "below average," 90-109 indicated "average," 110-119 indicated "above average," 120-129 indicated "high," and >129 indicated "very high" visual motor functioning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in visual motor functioning. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Participant has completed the treatment phase of their Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], GWEP1424 [NCT02224703], and GWEP1423 [NCT02224690].

Key Exclusion Criteria:

• Participant is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to study entry other than the investigational medicinal product (IMP) received during the Core Study and are unwilling to abstain for the duration for the study.

• Any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1.

• Participant has been part of a clinical trial involving an IMP during the inter-study period.

• Female participant is of child bearing potential or male participant's partner is of child bearing potential, unless willing to ensure that they or their partner use highly effective contraception, for example, hormonal contraceptives, intrauterine devices/hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence, during the study and for 3 months thereafter (however, a male condom should not be used in conjunction with a female condom).

• Participant has significantly impaired hepatic function at the 'End of Treatment' visit of their Core Study or at Visit 1 if re-assessed: i) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 × upper limit of normal (ULN); ii) ALT or AST >3 × ULN and (total bilirubin [TBL] >2 × ULN or international normalized ratio [INR] >1.5); iii) ALT or AST >3 × ULN with the presence of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%). This criterion must be confirmed prior to entering the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Jazz Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Apr 25, 2018
• Statistical Analysis Plan - Nov 6, 2020

More Information

Publications

None provided.

• Responsible Party: Jazz Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02224573
• Other Study ID Numbers: GWEP1415; 2014-001834-27
• First Posted: Aug 25, 2014
• Last Update Posted: Feb 3, 2022
• Last Verified: Jan 1, 2022

• Keywords provided by Jazz Pharmaceuticals: Cannabidiol; CBD; GWP42003-P; GWPCARE5
• Additional relevant MeSH terms: Epilepsies, Myoclonic; Lennox Gastaut Syndrome; Syndrome; Cannabidiol

Study Results

Participant Flow

Pre-assignment Detail	Participants who completed the double-blind, placebo-controlled, clinical studies with GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) were eligible for enrollment.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Period Title: Treatment Phase
STARTED	315	366
COMPLETED	170	243
NOT COMPLETED	145	123
Period Title: Treatment Phase
STARTED	79	71
COMPLETED	76	67
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome	Total
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Total of all reporting groups
Overall Participants	315	366	681
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	9.737 (4.4434)	15.906 (9.5392)	13.053 (8.2120)
Age, Customized (Count of Participants)
Children (2-11 years)	216 68.6%	157 42.9%	373 54.8%
Adolescents (12-17 years)	90 28.6%	89 24.3%	179 26.3%
Adults (18-64 years)	9 2.9%	120 32.8%	129 18.9%
Sex: Female, Male (Count of Participants)
Female	159 50.5%	168 45.9%	327 48%
Male	156 49.5%	198 54.1%	354 52%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.3%	0 0%	1 0.1%
Asian	6 1.9%	10 2.7%	16 2.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	10 3.2%	15 4.1%	25 3.7%
White	269 85.4%	325 88.8%	594 87.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	29 9.2%	16 4.4%	45 6.6%
Race (Count of Participants)
White/Caucasian	269 85.4%	325 88.8%	594 87.2%
Black/African American	10 3.2%	15 4.1%	25 3.7%
American Indian/Alaska Native	1 0.3%	0 0%	1 0.1%
Asian	6 1.9%	10 2.7%	16 2.3%
Not Applicable (As per country-specific data protection law.	15 4.8%	1 0.3%	16 2.3%
Caucasian/Asian	1 0.3%	1 0.3%	2 0.3%
Hispanic/Caucasian	1 0.3%	2 0.5%	3 0.4%
White and Black Caribbean	1 0.3%	0 0%	1 0.1%
Biracial	2 0.6%	1 0.3%	3 0.4%
Caucasian and African American	3 1%	1 0.3%	4 0.6%
Mulatto	1 0.3%	0 0%	1 0.1%
North African	1 0.3%	0 0%	1 0.1%
South American	1 0.3%	0 0%	1 0.1%
Latino	1 0.3%	5 1.4%	6 0.9%
Eurasian	1 0.3%	0 0%	1 0.1%
Anglo-Indian	1 0.3%	0 0%	1 0.1%
Indian	0 0%	2 0.5%	2 0.3%
Unknown	0 0%	2 0.5%	2 0.3%
Arab	0 0%	1 0.3%	1 0.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group
Description	TEAEs, defined as AEs that started, or worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, are reported. Any AEs that continued from the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) were only classified as treatment emergent if they worsened in this study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set: all participants who received at least 1 dose of investigational medicinal product (IMP).

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Total participants affected by any TEAE	306 97.1%	353 96.4%
Diarrhoea	135 42.9%	140 38.3%
Vomiting	63 20%	107 29.2%
Constipation	20 6.3%	43 11.7%
Nausea	16 5.1%	32 8.7%
Pyrexia	124 39.4%	126 34.4%
Fatigue	39 12.4%	38 10.4%
Upper respiratory tract infection	78 24.8%	104 28.4%
Nasopharyngitis	78 24.8%	58 15.8%
Sinusitis	38 12.1%	49 13.4%
Pneumonia	35 11.1%	51 13.9%
Ear infection	35 11.1%	50 13.7%
Influenza	37 11.7%	45 12.3%
Urinary tract infection	19 6%	51 13.9%
Pharyngitis streptococcal	26 8.3%	27 7.4%
Gastroenteritis viral	15 4.8%	30 8.2%
Otitis media	21 6.7%	22 6%
Bronchitis	15 4.8%	23 6.3%
Viral upper respiratory tract infection	11 3.5%	20 5.5%
Gastroenteritis	16 5.1%	7 1.9%
Fall	22 7%	23 6.3%
Laceration	8 2.5%	35 9.6%
Contusion	15 4.8%	25 6.8%
Weight decreased	21 6.7%	61 16.7%
Alanine aminotransferase increased	37 11.7%	30 8.2%
Aspartate aminotransferase increased	38 12.1%	19 5.2%
Gamma-glutamyltransferase increased	32 10.2%	20 5.5%
Decreased appetite	99 31.4%	93 25.4%
Convulsion	79 25.1%	141 38.5%
Somnolence	87 27.6%	107 29.2%
Status epilepticus	47 14.9%	42 11.5%
Lethargy	21 6.7%	34 9.3%
Headache	18 5.7%	26 7.1%
Sedation	16 5.1%	27 7.4%
Drooling	11 3.5%	21 5.7%
Abnormal behaviour	34 10.8%	23 6.3%
Insomnia	16 5.1%	40 10.9%
Irritability	26 8.3%	29 7.9%
Aggression	20 6.3%	30 8.2%
Agitation	9 2.9%	19 5.2%
Cough	42 13.3%	63 17.2%
Nasal congestion	13 4.1%	46 12.6%
Rhinorrhoea	20 6.3%	19 5.2%
Pneumonia aspiration	4 1.3%	22 6%
Hypoxia	2 0.6%	21 5.7%

2. Primary Outcome

Title	Number of Participants With Clinically Significant Changes in the Indicated Vital Sign Values From the Pre-randomization Baseline of the Core Study at Any Time Post-dose
Description	Clinical significance was determined by the investigator. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. bpm = beats per minute; DBP = Diastolic Blood Pressure; mmHg = millimeters of mercury; SBP = Systolic Blood Pressure. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Sitting SBP < -20 mmHg	59 18.7%	88 24%
Sitting SBP > 20 mmHg	96 30.5%	120 32.8%
Sitting DBP < -10 mmHg	139 44.1%	176 48.1%
Sitting DBP > 10 mmHg	166 52.7%	191 52.2%
Pulse Rate < -15 bpm	176 55.9%	192 52.5%
Pulse Rate > 15 bpm	150 47.6%	179 48.9%
Weight ≤ -7 %	47 14.9%	106 29%
Weight ≥ 7%	213 67.6%	223 60.9%

3. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Body Mass Index (BMI)
Description	BMI is an estimate of body fat based on body weight divided by height squared. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	243	294
Mean (Standard Deviation) [kilograms per meters squared (kg/m^2)]	0.42 (2.701)	0.05 (5.863)

4. Primary Outcome

Title	Number of Participants With Clinically Significant Electrocardiogram (ECG) Values at the Pre-randomization Baseline of the Core Study and at Any Time Post-dose
Description	Clinical significance was determined by the investigator. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. msec = milliseconds; QTcB = corrected QT interval with Bazett's correction. The time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
QTcB > 450 msec, Baseline	13 4.1%	21 5.7%
QTcB > 450 msec, any time post-dose	62 19.7%	120 32.8%
QTcB > 480 msec, Baseline	2 0.6%	4 1.1%
QTcB > 480 msec, any time post-dose	10 3.2%	40 10.9%
QTcB > 500 msec, Baseline	2 0.6%	2 0.5%
QTcB > 500 msec, any time post-dose	7 2.2%	20 5.5%

5. Primary Outcome

Title	Number of Participants With the Indicated Responses to Questions Regarding Suicidal Ideation and Behavior Using the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 1 and at Any Time Post-dose
Description	The C-SSRS questionnaire is a brief, standardized measure that uniquely assesses the essential information (behavior, ideation, lethality, and severity) and distinguishes between suicidal occurrences and non-suicidal self-injury.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Any suicidality, Day 1	1 0.3%	1 0.3%
Any suicidality, any time post-dose	1 0.3%	2 0.5%
Suicidal ideation, Day 1	0 0%	1 0.3%
Suicidal ideation, any time post-dose	1 0.3%	2 0.5%
Suicidal behavior, Day 1	1 0.3%	0 0%
Suicidal behavior, any time post-dose	1 0.3%	0 0%
Complete suicidality, any time post-dose	0 0%	0 0%

6. Primary Outcome

Title	Mean Cannabis Withdrawal Scale Score at End of Taper (EOT), the Post-Taper Safety Call, and at Safety Follow-up
Description	The Cannabis Withdrawal Scale is a 19-item scale administered to participants (18 years and above), with each item (withdrawal symptom) measured on a 0 to 10 numerical rating scale (0 = Not at all; 5 = Moderately; 10 = Extremely). Total score, calculated as the sum of the 19 item sub-scores ranging from 0-190 are reported. Higher scores indicate more withdrawal symptoms and an increased negative impact to quality of life. The participant or participant's caregiver was asked to record the extent to which each withdrawal symptom was experienced in the last 24 hours and also to rate the negative impact on normal daily activities. L24S = Last 24 Hours Score; NIS = Negative Impact on Normal Daily Activity Score. The End of Treatment visit occurred after a maximum of 260 weeks of treatment. The End of Taper occurred up to 10 days after the End of Treatment visit. The Safety Call and Safety Follow-up occurred 2 and 4 weeks, respectively, after the End of Taper.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants (18 years and above) with available Cannabis Withdrawal Scale score were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
L24S, End of Taper	9.8 (10.64)	4.9 (14.00)
L24S, Post-Taper Safety Call	3.4 (4.72)	0.0 (0.00)
L24S, Safety Follow-Up	2.4 (3.36)	4.9 (12.27)
NIS, End of Taper	9.5 (12.03)	5.1 (10.96)
NIS, Post-Taper Safety Call	16.3 (3.79)	1.2 (3.00)
NIS, Safety Follow-Up	5.3 (9.24)	1.8 (3.82)

7. Primary Outcome

Title	Mean Pediatric Cannabinoid Withdrawal Scale (PCWS) Score at the End of Treatment, the End of Taper, the Post-Taper Safety Call, and at Safety Follow-up
Description	The PCWS was administered to participants aged 4 to 17 (inclusive) that was developed from the 19-item validated CWS (adults) to assess mood, behavioral, and physical symptoms associated with cannabis. The total score, calculated as the sum of 10 items (rated on a 4-point scale: 0 = none; 1 = a little bit; 2 = quite a bit; 3 = a lot) ranging from 0-30 are reported. Higher scores indicate more withdrawal symptoms and an increased negative impact to quality of life. The End of Treatment visit occurred after a maximum of 260 weeks of treatment. The participant or participant's caregiver was asked to record the extent to which each withdrawal symptom was experienced in the last 24 hours and also to rate the negative impact on normal daily activities. The End of Taper occurred up to 10 days after the End of Treatment visit. The Safety Call and Safety Follow-up occurred 2 and 4 weeks, respectively, after the End of Taper.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants (4 to 17 years) with available Pediatric Cannabis Withdrawal Scale score were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	74	46
End of Treatment	4.0 (NA)	6.0 (NA)
End of Taper	2.9 (3.77)	2.1 (2.78)
Post-Taper Safety Call	2.4 (3.50)	2.0 (2.72)
Safety Follow-Up	1.9 (2.72)	1.8 (2.28)

8. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Red Blood Cells (RBCs) Values
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	268	307
Mean (Standard Deviation) [10^12 cells per Liter (L)]	-0.068 (0.3297)	-0.059 (0.3424)

9. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Hemoglobin Levels
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	268	307
Mean (Standard Deviation) [grams per Liter (g/L)]	-1.6 (9.08)	-2.4 (11.14)

10. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Hematocrit Values
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	268	307
Mean (Standard Deviation) [percentage of RBCs in whole blood (L/L)]	-0.0105 (0.02938)	-0.0110 (0.02983)

11. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Erythrocyte Mean Corpuscular Volume
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	268	307
Mean (Standard Deviation) [femtoliters (fL)]	-1.0 (5.10)	-1.3 (5.01)

12. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Erythrocyte Mean Corpuscular Hemoglobin
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	268	307
Mean (Standard Deviation) [picograms (pg)]	0.10 (1.482)	-0.15 (1.926)

13. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Platelets, White Blood Cells, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Platelets	5.4 (64.84)	5.0 (70.47)
White blood cells	-0.52 (2.531)	-0.09 (2.052)
Basophils	0.00 (0.041)	0.01 (0.040)
Eosinophils	-0.02 (0.159)	-0.02 (0.165)
Lymphocytes	-0.31 (0.988)	-0.14 (0.778)
Monocytes	-0.05 (0.276)	0.01 (0.245)
Neutrophils	-0.16 (2.041)	0.05 (1.878)

14. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils in White Blood Cells (WBCs)
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	268	305
Basophils/WBCs	0.08 (0.284)	0.12 (0.287)
Eosinophils/WBCs	-0.10 (2.064)	-0.24 (2.104)
Lymphocytes/WBCs	-1.32 (12.396)	-1.32 (11.193)
Monocytes/WBCs	-0.05 (3.125)	0.18 (2.600)
Neutrophils/WBCs	1.47 (12.982)	1.27 (12.245)

15. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Sodium, Potassium, Blood Urea Nitrogen, Glucose, Calcium, and High-Density Lipoprotein (HDL) Cholesterol
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Sodium	-0.4 (3.25)	-0.8 (2.70)
Potassium	-0.06 (0.372)	-0.08 (0.407)
Blood urea nitrogen	-0.08 (1.571)	0.00 (1.555)
Glucose	-0.06 (1.026)	0.06 (1.288)
Calcium	-0.050 (0.1148)	-0.054 (0.1218)
HDL cholesterol	0.06 (0.372)	0.12 (0.320)

16. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Creatinine (Jaffe), Creatinine (Enzymatic), and Bilirubin
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Creatinine, Jaffe	7.0 (9.32)	7.1 (10.86)
Creatinine, enzymatic	3.8 (8.83)	4.0 (9.44)
Bilirubin	0.48 (2.339)	0.45 (2.626)

17. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Creatinine Clearance (Schwartz) and Creatinine Clearance (Cockcroft-Gault)
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. mL/min/1.73 m^2 = millilitres per minute per 1.73 meters squared. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Creatinine Clearance, Schwartz,	0.3 (4.41)	0.0 (0.00)
Creatinine Clearance, Cockcroft-Gault	0.0 (0.00)	-0.6 (5.94)

18. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, and Gamma Glutamyl Transferase
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Alkaline phosphatase	-40.9 (88.18)	-40.1 (73.62)
Aspartate aminotransferase	4.0 (26.14)	2.8 (26.62)
Alanine aminotransferase	7.0 (39.24)	9.5 (43.96)
Gamma glutamyl transferase	8.7 (42.35)	4.9 (45.65)

19. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Albumin and Protein
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Albumin	-0.2 (3.43)	-0.9 (3.31)
Protein	-1.2 (5.83)	-2.0 (5.75)

20. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prolactin
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	276	309
Mean (Standard Deviation) [µInternational Units/millilitre (µIU/mL)]	0.43 (132.613)	10.43 (230.439)

21. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prothrombin Time
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	256	282
Mean (Standard Deviation) [seconds]	-0.08 (0.740)	-0.09 (0.706)

22. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prothrombin International Normalized Ratio
Description	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	256	282
Mean (Standard Deviation) [ratio]	-0.012 (0.0784)	-0.010 (0.0736)

23. Primary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Insulin-like Growth Factor-1 (IGF-1) Levels
Description	IGF-1 levels in serum were analyzed as part of the clinical laboratory testing in participants. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	69	142
Mean (Standard Deviation) [nanomoles (nmol)/L]	-0.28 (12.701)	1.10 (15.970)

24. Primary Outcome

Title	Mean Subject/Caregiver Global Impression of Change (S/CGIC) Score
Description	The S/CGIC allows participants and caregivers to rate the participant's overall condition on a scale of 1 to 7 (1 = Very Much Improved, and 7 = Very Much Worse). The combined caregiver and participant summary used either the caregiver or participant version if only one version was completed, or the caregiver version when both the caregiver and participant versions were completed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only those participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Mean (Standard Deviation) [Scores on a scale]	3.0 (1.47)	2.8 (1.38)

25. Primary Outcome

Title	Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Total Seizure Frequency
Description	Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver. Change from Baseline was calculated as the percentage change from Baseline for each 12-week period. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. "Last 12 weeks" is equal to the last 12 weeks' data for each participant irrespective of time in study.
Time Frame	Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, Week 253 to 264, and Last 12 Weeks

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Week 49 to 60	-65.8	-58.9
Week 97 to 108	-71.3	-66.4
Week 145 to 156	-79.8	-65.3
Week 205 to 216	-81.5	-78.4
Week 253 to 264	-70.0
Last 12 weeks	-55.2	-51.9

26. Primary Outcome

Title	Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Drop Seizure Frequency in Participants With Lennox-Gastaut Syndrome
Description	Drop seizures are defined as the subset of tonic-clonic, tonic, or atonic seizures. Change from Baseline was calculated as the percentage change from Baseline for each 12-week period. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. The outcome was reported for Lennox-Gastaut Syndrome participants only. "Last 12 weeks" is equal to the last 12 weeks' data for each participant irrespective of time in study.
Time Frame	Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, and Last 12 Weeks

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	366
Week 49 to 60	-59.4
Week 97 to 108	-69.4
Week 145 to 156	-70.8
Week 205 to 216	-68.7
Last 12 weeks	-59.4

27. Primary Outcome

Title	Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Convulsive Seizure Frequency in Participants With Dravet Syndrome
Description	Convulsive seizures are defined as tonic-clonic, tonic, clonic, or atonic seizures. Change from Baseline was calculated as the percentage change from Baseline for each 12-week period. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. The outcome was reported for Dravet Syndrome participants only. "Last 12 weeks" is equal to the last 12 weeks' data for each participant irrespective of time in study.
Time Frame	Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, Week 253 to 264, and Last 12 Weeks

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315
Week 49 to 60	-52.9
Week 97 to 108	-64.3
Week 145 to 156	-69.4
Week 205 to 216	-72.3
Week 253 to 264	-55.6
Last 12 weeks	-40.0

28. Primary Outcome

Title	Number of Participants With Convulsive and Non-convulsive Seizures Greater Than 30 Minutes in Duration (Status Epilepticus)
Description	Status epilepticus is defined as any seizure lasting for 30 minutes or longer. The number of convulsive seizures greater than 30 minutes in duration and the number of non-convulsive seizures greater than 30 minutes in duration were collected weekly. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. mins = minutes. "Last 12 weeks" is equal to the last 12 weeks' data for each participant irrespective of time in study.
Time Frame	Baseline; At last 12 weeks

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data are analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Convulsive SE: Over the 4-week Baseline; Yes	14 4.4%	14 3.8%
Convulsive SE: Last 12 Weeks; Yes	13 4.1%	7 1.9%
Convulsive SE: Over the 4-week Baseline; No	277 87.9%	352 96.2%
Convulsive SE: Last 12 Weeks; No	277 87.9%	356 97.3%
Non-Convulsive SE: Over the 4-week Baseline; Yes	21 6.7%	17 4.6%
Non-Convulsive SE: Last 12 Weeks; Yes	14 4.4%	11 3%
Non-Convulsive SE: Over the 4-week Baseline; No	270 85.7%	349 95.4%
Non-Convulsive SE: Last 12 Weeks; No	276 87.6%	352 96.2%

29. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Quality of Life in Childhood Epilepsy (QOLCE) Scores
Description	The QOLCE is a parent-reported questionnaire that evaluates health-related QOL in children aged 2-18 years old. It contains 76 items with 16 subscales covering 7 domains (physical activities, social activities, cognition, emotional well-being, behavior, general health, and general QOL). All items in the questionnaire are rated on a 5-point or 6-point categorical scale. Based on the responses to the items in each domain, scores for 16 subscales are derived. Score range from 0 to 100. Higher score indicate highest level of functioning. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study is defined as the Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	169	118
Mean (Standard Deviation) [Scores on a scale]	3.7 (14.61)	6.0 (13.87)

30. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment QOL in Epilepsy Scores (QOLIE-31-P) in Participants With Lennox-Gastaut Syndrome
Description	The QOLIE-31-P is a survey of health-related QOL for adults with epilepsy. It is comprised of 38 questions about health daily activities and evaluates how much distress the participant feels about problems and worries related to epilepsy. The questionnaire consists of 7 subscales (energy, mood, daily activities, cognition, medication effects, seizure worry, and overall QOL). Scores range from 0 to 100. Higher scores indicate better QOL. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. The outcome was reported for Lennox-Gastaut Syndrome participants only.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	38
Mean (Standard Deviation) [Scores on a scale]	1.3 (16.33)

31. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores
Description	The Vineland-II is an individually administered instrument for assessing adaptive behaviors. It consists of 4 adaptive behavior domains (1 = low; 5 = high) and a maladaptive behavior domain (1 = clinically significant; 3 = average), and an overall Adaptive Behavior Composite Score. Standard scores (population mean = 100, SD = 15, range = 20 to 160) are produced for the domain and composite scores, and scaled scores (called v-scale scores, with a population mean = 15, SD = 3, range = 1 to 24) are produced for the subscale scores. Higher scores indicate better functioning. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only those participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Communication: Receptive Subdomain v-Scale Score	-0.4 (2.12)	-0.5 (2.76)
Communication: Expressive Subdomain v-Scale Score	-0.8 (1.65)	-0.3 (2.20)
Communication: Written Subdomain v-Scale Score	-1.1 (1.80)	-0.7 (1.80)
Communication Domain Standard Score	-3.2 (8.75)	-1.6 (13.50)
Daily Living Skills: Personal Subdomain v-Scale Score	-1.0 (1.92)	-0.8 (2.05)
Daily Living Skills: Domestic Subdomain v-Scale Score	-0.8 (2.04)	-1.0 (1.32)
Daily Living Skills: Community Subdomain v-Scale Score	-0.9 (2.75)	-0.8 (1.49)
Daily Living Skills Domain Standard Score	-5.0 (9.68)	-3.9 (8.40)
Socialization: Interpersonal Relationships Subdomain v-Scale Score	-0.7 (1.66)	-0.6 (2.17)
Socialization: Play and Leisure Time Subdomain v-Scale Score	-0.9 (2.29)	-0.4 (2.22)
Socialization: Coping Skills Subdomain v-Scale Score	-0.7 (2.24)	-0.5 (1.85)
Socialization Domain Standard Score	-3.3 (9.38)	-3.4 (11.29)
Motor Skills: Gross Subdomain v-Scale Score	-0.2 (1.64)	-0.3 (1.88)
Motor Skills: Fine Subdomain v-Scale Score	-0.3 (1.99)	-0.4 (2.19)
Motor Skills Domain Standard Score	-0.7 (9.62)	-1.9 (10.23)
Adaptive Behavior Composite Standard Score	-3.4 (8.09)	-2.5 (10.07)
Maladaptive Behavior Index: Internalizing Subdomain v-Scale Score	-0.1 (2.28)	-0.1 (2.64)
Maladaptive Behavior Index: Externalizing Subdomain v-Scale Score	-0.3 (2.22)	-0.1 (2.12)
Maladaptive Behavior Index v-Scale Score	-0.3 (1.92)	-0.3 (2.09)

32. Secondary Outcome

Title	Number of Participants With Inpatient Hospitalizations Due to Epilepsy Since the Previous Visit
Description	Inpatient hospitalizations due to epilepsy were recorded by the investigator. The timing of the "End of Treatment" varied per participant based on when the participant discontinued IMP.
Time Frame	Week 48, 104, 156, 208, and End of Treatment (up to Week 260 based on when the participant discontinued treatment)

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Week 48	5 1.6%	9 2.5%
Week 104	4 1.3%	9 2.5%
Week 156	3 1%	0 0%
Week 208	0 0%	0 0%
End of Treatment	16 5.1%	17 4.6%

33. Secondary Outcome

Title	Number of Treatment Responders With Greater Than or Equal to 50% Reduction in Total Seizures
Description	Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver.
Time Frame	Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, Week 253 to 264, and Last 12 Weeks

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Week 49 to 60	108 34.3%	169 46.2%
Week 97 to 108	73 23.2%	148 40.4%
Week 145 to 156	48 15.2%	128 35%
Week 205 to 216	7 2.2%	12 3.3%
Week 253 to 264	2 0.6%
Last 12 Weeks	153 48.6%	188 51.4%

34. Secondary Outcome

Title	Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD)
Description	The SGICSD and CGICSD are comprised of the following questions rated on a 3-point scale for each seizure type. The CGICSD score is used to assess the average duration of the participant's seizures (comparing their condition now to their condition before treatment) and the SGICSD score is used to assess the average duration of seizures (comparing condition now to condition before treatment). Scores range from 1 to 3 (1 = Decrease in average duration; 3 = Increase in average duration).
Time Frame	Up to Week 260

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Only participants with available data are analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	291	366
Decrease in average duration	89 28.3%	101 27.6%
Increase in average duration	17 5.4%	24 6.6%
Decrease in average duration	39 12.4%	132 36.1%
Increase in average duration	8 2.5%	18 4.9%
Decrease in average duration	41 13%	38 10.4%
Increase in average duration	4 1.3%	3 0.8%
Decrease in average duration	26 8.3%	98 26.8%
Increase in average duration	6 1.9%	10 2.7%
Decrease in average duration	48 15.2%	72 19.7%
Increase in average duration	14 4.4%	4 1.1%
Decrease in average duration	34 10.8%	41 11.2%
Increase in average duration	8 2.5%	5 1.4%
Decrease in average duration	25 7.9%	29 7.9%
Increase in average duration	6 1.9%	0 0%
Decrease in average duration	42 13.3%	83 22.7%
Increase in average duration	9 2.9%	3 0.8%

35. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Delis-Kaplan Executive Function System (D-KEFS) Visual Scanning Completion Time Scaled Score
Description	D-KEFS Visual Scanning Completion Time Scale was used to measure visual attention and processing speed. The cognitive assessment battery items are age-specific, used to measure a variety of functions for both children and adults. The items were administered by an experienced psychometrician to a sub-group of sites that had the expertise to conduct the test. The raw score i.e., total time in seconds for completing the visual scanning trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to convert into a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better functioning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in cognitive function.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	2	3
Mean (Standard Deviation) [Score on a scale]	0.00 (0.00)	-0.33 (0.577)

36. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Number Sequencing Completion Time Scaled Score
Description	D-KEFS Number Sequencing Completion Time Scale was used to measure processing speed. The raw score i.e., total time in seconds for completing the number sequencing trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to convert into a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	2	2
Mean (Standard Deviation) [Score on a scale]	0.00 (0.00)	0.00 (0.00)

37. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Letter Sequencing Completion Time Scaled Score
Description	D-KEFS Letter Sequencing Completion Time Scaled was used to measure processing speed. The raw score i.e., total time in seconds for completing the letter sequencing trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	2	2
Mean (Standard Deviation) [Score on a scale]	0.00 (0.00)	0.00 (0.00)

38. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Number-letter Switching Completion Time Scaled Score
Description	D-KEFS Number-letter Switching Completion Time Scale was used to measure cognitive flexibility, task-set switching, and general executive functioning. The raw score i.e., total time in seconds for completing the number-letter switching trial was measured in the range of 0-240; higher scores indicated worse functioning. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better functioning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in cognitive function. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	2	2
Mean (Standard Deviation) [Score on a scale]	0.00 (0.00)	0.00 (0.00)

39. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Motor Speed Completion Time Scaled Score
Description	D-KEFS Motor Speed Completion Time Scale was used to measure motor speed. The raw score i.e., total time in seconds for completing the motor speed trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better motor speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in motor speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	2	3
Mean (Standard Deviation) [Score on a scale]	0.00 (0.00)	-1.33 (2.309)

40. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Both Hands Z Score)
Description	Purdue Pegboard test was used to measure fine motor dexterity of both hands. The raw score was calculated as the total number of pegs in 30 seconds; higher scores indicated higher level of motor dexterity. The raw score was converted to a Z-score ranging from 0-19; higher scores indicate a higher level of motor dexterity. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as Z-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in motor dexterity. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	17	11
Mean (Standard Deviation) [Z Score]	1.26 (3.272)	9.55 (21.070)

41. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Dominant Hand Z Score)
Description	Purdue Pegboard test was used to measure fine motor dexterity of the dominant hand. The raw score was calculated as the total number of pegs in 30 seconds; higher scores indicated higher level of motor dexterity. The raw score was converted to a Z-score ranging from 0-19; higher scores indicate a higher level of motor dexterity. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as Z-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in motor dexterity. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	17	12
Mean (Standard Deviation) [Z Score]	1.16 (3.192)	9.23 (18.083)

42. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Non Dominant Hand Z Score)
Description	Purdue Pegboard test was used to measure fine motor dexterity of the non dominant hand. The raw score was calculated as the total number of pegs in 30 seconds; higher scores indicated higher level of motor dexterity. The raw score was converted to a Z-score ranging from 0-19; higher scores indicate a higher level of motor dexterity. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as Z-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in motor dexterity. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	17	12
Mean (Standard Deviation) [Z Score]	1.31 (3.329)	10.21 (21.852)

43. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Adult Intelligence Scale (WAIS) Coding Scaled Score
Description	WAIS Coding Scale was used to measure processing speed. The raw score i.e., sum of correct substitutions was measured in the range of 0-16. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	0	2
Mean (Standard Deviation) [Score on a scale]	0.00 (0.00)

44. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Backward Scaled Score
Description	WAIS Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured in the range of 0-16. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Baseline	0.0 (NA)	0.0 (0.0)
Week 48	0.0 (NA)	0.25 (0.50)
End of Treatment	-0.14 (0.378)

45. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Forward Scaled Score
Description	WAIS Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured in the range of 0-16. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Baseline	0.0 (NA)	0.13 (1.808)
Week 48	0.0 (NA)	-0.25 (1.258)
End of Treatment	0.14 (2.268)

46. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Backward Scaled Score
Description	WAIS Longest Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured in the range of 2-8. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Baseline	0.00 (NA)	0.00 (0.00)
Week 48	0.00 (NA)	0.00 (0.00)
End of Treatment	0.00 (0.00)

47. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Forward Scaled Score
Description	WAIS Longest Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured in the range of 2-8. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Baseline	0.0 (NA)	0.13 (1.642)
Week 48	0.0 (NA)	0.25 (1.258)
End of Treatment	-0.14 (1.574)

48. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Abbreviated Scale of Intelligence (WASI)-II Vocabulary T Score
Description	WAIS-II Vocabulary T Score was used to estimate general intellectual ability based on fund of information and verbal intelligence. The raw score i.e., the sum of correct responses was converted to a T-score ranging from 20-80 using the WASI assessment manual; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of intelligence. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in intelligence. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	4	6
Mean (Standard Deviation) [T Score]	0.00 (0.00)	-4.00 (12.247)

49. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WASI-II Matrix Reasoning T Score
Description	WASI-II Matrix Reasoning T Score was used to estimate general intellectual ability based abstract reasoning. The raw score i.e., the sum of correct responses was converted to a T-score ranging from 20-80 using the WASI assessment manual; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of abstract reasoning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in abstract reasoning. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	4	7
Mean (Standard Deviation) [T Score]	-1.50 (3.000)	-3.29 (5.376)

50. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Intelligence Scale for Children (WISC) Coding Scaled Score
Description	WISC Coding Scale was used to measure processing speed in children aged 6-16 years 11 months, with scores ranging from 0 to 119. Higher scores indicate better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	5	0
Mean (Standard Deviation) [Score on a scale]	-0.40 (1.817)

51. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Digit Span Backward Scaled Score
Description	WISC Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured on a scale of 0-18; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	6	0
Mean (Standard Deviation) [Score on a scale]	0.00 (0.632)

52. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Digit Span Forward Scaled Score
Description	WISC Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured on a scale of 0-18; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	7	0
Mean (Standard Deviation) [Score on a scale]	0.57 (0.787)

53. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Longest Digit Span Backward Scaled Score
Description	WISC Longest Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured on a scale of 2-8; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	6	0
Mean (Standard Deviation) [Score on a scale]	0.00 (1.265)

54. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Longest Digit Span Forward Scaled Score
Description	WISC Longest Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured on a scale of 2-10; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	6	0
Mean (Standard Deviation) [Score on a scale]	0.17 (0.408)

55. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Preschool & Primary Scale of Intelligence (WPPSI)-IV Bug Search T Score
Description	WPPSI-IV Bug Search T Score was used to measure processing speed and complex attention. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 20-80; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of attention. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in attention. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	0
Baseline	0.0 (0.0)
Week 48	0.0 (NA)

56. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WPPSI-IV Receptive Vocabulary T Score
Description	WPPSI-IV Receptive Vocabulary T Score was used to measure fund of information. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 20-80; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of intelligence. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in intelligence. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	0	1
Mean (Standard Deviation) [T Score]	-1.00 (NA)

57. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WPPSI-IV Matrix Reasoning T Score
Description	WPPSI-IV Matrix Reasoning T Score was used to measure abstract reasoning. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 20-80; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of abstract reasoning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in abstract reasoning. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	315	366
Baseline	0.75 (6.994)	-19.0 (NA)
Week 48	-0.75 (6.994)

58. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Expressive One-Word Picture Vocabulary Test (EOWPVT) Scaled Score
Description	Expressive One-Word Picture Vocabulary Test-4th edition was used to test vocabulary. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 0-83; T-scores are standard scores with a mean of 100 and a standard deviation of 15. Higher scores indicate a higher level of language performance. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in language performance. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	2	2
Mean (Standard Deviation) [T score]	-31.00 (56.569)	-31.00 (53.740)

59. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in a Developmental NEuroPSYchological Assessment (NEPSY)-2 Word Generation Scaled Score
Description	Developmental NEuroPSYchological Assessment (NEPSY)-2 Word Generation Scale was used to measure verbal fluency. The raw score i.e., the sum of correct responses was converted to a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicate a higher level of verbal fluency. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in verbal fluency. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	2	1
Mean (Standard Deviation) [Score on a scale]	-1.00 (1.414)	3.39 (NA)

60. Secondary Outcome

Title	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Visual Perception Standard Scaled Score
Description	Visual Perception Standard scale was used to measure visual motor functioning. The raw score i.e., the sum of the correct responses was measured on a 6-standard score range. Score range of 70-79 indicated "low," 80-89 indicated "below average," 90-109 indicated "average," 110-119 indicated "above average," 120-129 indicated "high," and >129 indicated "very high" visual motor functioning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in visual motor functioning. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.
Time Frame	Baseline; up to Week 260

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Only participants with available data were analyzed.

Arm/Group Title	Dravet Syndrome	Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Measure Participants	1	3
Mean (Standard Deviation) [Score on a scale]	0.00 (NA)	2.67 (7.767)

Adverse Events

Time Frame	Up to Week 260
Adverse Event Reporting Description	Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Arm/Group Title	Dravet Syndrome		Lennox-Gastaut Syndrome
Arm/Group Description	Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.		Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
All Cause Mortality
	Dravet Syndrome		Lennox-Gastaut Syndrome
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/315 (1.9%)		12/366 (3.3%)
Serious Adverse Events
	Dravet Syndrome		Lennox-Gastaut Syndrome
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	133/315 (42.2%)		157/366 (42.9%)
Blood and lymphatic system disorders
Anaemia macrocytic	0/315 (0%)		1/366 (0.3%)
Eosinophilia	0/315 (0%)		1/366 (0.3%)
Immune thrombocytopenic purpura	1/315 (0.3%)		0/366 (0%)
Iron deficiency anaemia	0/315 (0%)		1/366 (0.3%)
Neutropenia	3/315 (1%)		0/366 (0%)
Thrombocytopenia	2/315 (0.6%)		1/366 (0.3%)
Cardiac disorders
Cardiac arrest	0/315 (0%)		1/366 (0.3%)
Cardio-respiratory arrest	1/315 (0.3%)		1/366 (0.3%)
Tachycardia	0/315 (0%)		1/366 (0.3%)
Congenital, familial and genetic disorders
Rett's disorder	0/315 (0%)		1/366 (0.3%)
Eye disorders
Blindness transient	0/315 (0%)		1/366 (0.3%)
Eye oedema	0/315 (0%)		1/366 (0.3%)
Gastrointestinal disorders
Abdominal discomfort	0/315 (0%)		1/366 (0.3%)
Abdominal distension	0/315 (0%)		1/366 (0.3%)
Abdominal pain	0/315 (0%)		3/366 (0.8%)
Abdominal pain upper	0/315 (0%)		1/366 (0.3%)
Colitis	0/315 (0%)		1/366 (0.3%)
Constipation	0/315 (0%)		3/366 (0.8%)
Diarrhoea	5/315 (1.6%)		5/366 (1.4%)
Faecaloma	1/315 (0.3%)		1/366 (0.3%)
Gastrointestinal disorder	0/315 (0%)		1/366 (0.3%)
Gastrointestinal necrosis	0/315 (0%)		1/366 (0.3%)
Haematemesis	0/315 (0%)		2/366 (0.5%)
Haematochezia	0/315 (0%)		1/366 (0.3%)
Ileus	0/315 (0%)		4/366 (1.1%)
Ileus paralytic	0/315 (0%)		1/366 (0.3%)
Impaired gastric emptying	0/315 (0%)		1/366 (0.3%)
Intestinal ischaemia	0/315 (0%)		1/366 (0.3%)
Intestinal obstruction	1/315 (0.3%)		3/366 (0.8%)
Intestinal perforation	0/315 (0%)		1/366 (0.3%)
Localised intraabdominal fluid collection	0/315 (0%)		1/366 (0.3%)
Nausea	0/315 (0%)		3/366 (0.8%)
Oesophagitis	0/315 (0%)		1/366 (0.3%)
Pneumatosis intestinalis	0/315 (0%)		1/366 (0.3%)
Proctalgia	0/315 (0%)		1/366 (0.3%)
Small intestinal obstruction	0/315 (0%)		2/366 (0.5%)
Tooth loss	0/315 (0%)		1/366 (0.3%)
Vomiting	0/315 (0%)		13/366 (3.6%)
General disorders
Asthenia	0/315 (0%)		1/366 (0.3%)
Chest pain	1/315 (0.3%)		0/366 (0%)
Device dislocation	0/315 (0%)		1/366 (0.3%)
Device malfunction	0/315 (0%)		1/366 (0.3%)
Drowning	1/315 (0.3%)		0/366 (0%)
Drug withdrawal syndrome	0/315 (0%)		1/366 (0.3%)
Effusion	1/315 (0.3%)		0/366 (0%)
Fatigue	1/315 (0.3%)		0/366 (0%)
Generalised oedema	0/315 (0%)		1/366 (0.3%)
Hypothermia	0/315 (0%)		2/366 (0.5%)
Malaise	1/315 (0.3%)		0/366 (0%)
Pain	1/315 (0.3%)		0/366 (0%)
Pyrexia	17/315 (5.4%)		11/366 (3%)
Sudden unexplained death in epilepsy	4/315 (1.3%)		4/366 (1.1%)
Hepatobiliary disorders
Cholecystitis	0/315 (0%)		1/366 (0.3%)
Drug-induced liver injury	0/315 (0%)		1/366 (0.3%)
Hepatitis	1/315 (0.3%)		0/366 (0%)
Hepatitis acute	0/315 (0%)		1/366 (0.3%)
Hepatotoxicity	1/315 (0.3%)		0/366 (0%)
Infections and infestations
Abdominal wall abscess	0/315 (0%)		1/366 (0.3%)
Appendicitis	2/315 (0.6%)		1/366 (0.3%)
Appendicitis perforated	1/315 (0.3%)		0/366 (0%)
Atypical pneumonia	0/315 (0%)		1/366 (0.3%)
Bacteraemia	0/315 (0%)		2/366 (0.5%)
Bronchitis	1/315 (0.3%)		0/366 (0%)
Campylobacter gastroenteritis	0/315 (0%)		1/366 (0.3%)
Catheter site abscess	0/315 (0%)		1/366 (0.3%)
Cellulitis	1/315 (0.3%)		2/366 (0.5%)
Cellulitis staphylococcal	0/315 (0%)		1/366 (0.3%)
Clostridium difficile infection	0/315 (0%)		1/366 (0.3%)
Colon gangrene	0/315 (0%)		1/366 (0.3%)
Corona virus infection	1/315 (0.3%)		0/366 (0%)
Croup infectious	1/315 (0.3%)		0/366 (0%)
Cystitis	0/315 (0%)		1/366 (0.3%)
Device related infection	0/315 (0%)		1/366 (0.3%)
Empyema	0/315 (0%)		1/366 (0.3%)
Enterococcal infection	1/315 (0.3%)		0/366 (0%)
Enterovirus infection	2/315 (0.6%)		0/366 (0%)
Epstein-Barr virus infection	1/315 (0.3%)		0/366 (0%)
Escherichia infection	1/315 (0.3%)		0/366 (0%)
Gastroenteritis	0/315 (0%)		1/366 (0.3%)
Gastroenteritis viral	4/315 (1.3%)		2/366 (0.5%)
Infected bites	1/315 (0.3%)		0/366 (0%)
Infection	0/315 (0%)		1/366 (0.3%)
Infectious mononucleosis	1/315 (0.3%)		0/366 (0%)
Infective myositis	0/315 (0%)		1/366 (0.3%)
Influenza	7/315 (2.2%)		3/366 (0.8%)
Klebsiella infection	1/315 (0.3%)		0/366 (0%)
Laryngitis	1/315 (0.3%)		0/366 (0%)
Lobar pneumonia	1/315 (0.3%)		5/366 (1.4%)
Lower respiratory tract infection	2/315 (0.6%)		1/366 (0.3%)
Meningitis viral	1/315 (0.3%)		0/366 (0%)
Metapneumovirus infection	1/315 (0.3%)		1/366 (0.3%)
Myelitis	0/315 (0%)		1/366 (0.3%)
Oral candidiasis	0/315 (0%)		1/366 (0.3%)
Otitis externa	0/315 (0%)		1/366 (0.3%)
Otitis media	0/315 (0%)		2/366 (0.5%)
Otitis media acute	0/315 (0%)		1/366 (0.3%)
Parainfluenzae virus infection	2/315 (0.6%)		2/366 (0.5%)
Peritonitis	0/315 (0%)		1/366 (0.3%)
Pertussis	1/315 (0.3%)		0/366 (0%)
Pharyngitis	1/315 (0.3%)		0/366 (0%)
Pharyngitis streptococcal	2/315 (0.6%)		1/366 (0.3%)
Pneumonia	20/315 (6.3%)		26/366 (7.1%)
Pneumonia bacterial	1/315 (0.3%)		1/366 (0.3%)
Pneumonia influenzal	0/315 (0%)		1/366 (0.3%)
Pneumonia pseudomonal	0/315 (0%)		1/366 (0.3%)
Pneumonia respiratory syncytial viral	1/315 (0.3%)		0/366 (0%)
Pneumonia staphylococcal	1/315 (0.3%)		1/366 (0.3%)
Pneumonia viral	2/315 (0.6%)		2/366 (0.5%)
Pseudomonas infection	1/315 (0.3%)		0/366 (0%)
Pyelonephritis	0/315 (0%)		1/366 (0.3%)
Pyelonephritis acute	1/315 (0.3%)		1/366 (0.3%)
Rectal abscess	0/315 (0%)		1/366 (0.3%)
Respiratory syncytial virus infection	4/315 (1.3%)		0/366 (0%)
Respiratory tract infection	1/315 (0.3%)		2/366 (0.5%)
Respiratory tract infection viral	1/315 (0.3%)		0/366 (0%)
Rhinovirus infection	3/315 (1%)		2/366 (0.5%)
Sepsis	0/315 (0%)		6/366 (1.6%)
Septic shock	1/315 (0.3%)		2/366 (0.5%)
Sinusitis	0/315 (0%)		1/366 (0.3%)
Staphylococcal infection	1/315 (0.3%)		2/366 (0.5%)
Superinfection	0/315 (0%)		1/366 (0.3%)
Superinfection bacterial	1/315 (0.3%)		0/366 (0%)
Tracheitis	0/315 (0%)		1/366 (0.3%)
Tracheobronchitis	0/315 (0%)		1/366 (0.3%)
Upper respiratory tract infection	3/315 (1%)		2/366 (0.5%)
Urinary tract infection	1/315 (0.3%)		9/366 (2.5%)
Viral infection	1/315 (0.3%)		3/366 (0.8%)
Viral pharyngitis	1/315 (0.3%)		1/366 (0.3%)
Viral upper respiratory tract infection	3/315 (1%)		1/366 (0.3%)
West Nile viral infection	0/315 (0%)		1/366 (0.3%)
Wound infection	0/315 (0%)		1/366 (0.3%)
Injury, poisoning and procedural complications
Concussion	0/315 (0%)		1/366 (0.3%)
Contusion	0/315 (0%)		1/366 (0.3%)
Ear injury	0/315 (0%)		1/366 (0.3%)
Extradural haematoma	1/315 (0.3%)		0/366 (0%)
Eye contusion	0/315 (0%)		1/366 (0.3%)
Fall	2/315 (0.6%)		3/366 (0.8%)
Feeding tube complication	1/315 (0.3%)		1/366 (0.3%)
Femur fracture	0/315 (0%)		1/366 (0.3%)
Foot fracture	0/315 (0%)		1/366 (0.3%)
Fracture	0/315 (0%)		1/366 (0.3%)
Hand fracture	1/315 (0.3%)		0/366 (0%)
Head injury	1/315 (0.3%)		0/366 (0%)
Injury	0/315 (0%)		1/366 (0.3%)
Jaw fracture	0/315 (0%)		1/366 (0.3%)
Lumbar vertebral fracture	0/315 (0%)		1/366 (0.3%)
Multiple fractures	1/315 (0.3%)		0/366 (0%)
Near drowning	2/315 (0.6%)		1/366 (0.3%)
Post procedural haemorrhage	0/315 (0%)		1/366 (0.3%)
Skull fracture	1/315 (0.3%)		1/366 (0.3%)
Subdural haematoma	0/315 (0%)		1/366 (0.3%)
Tooth avulsion	0/315 (0%)		1/366 (0.3%)
Toxicity to various agents	1/315 (0.3%)		2/366 (0.5%)
Tracheal haemorrhage	0/315 (0%)		1/366 (0.3%)
Traumatic intracranial haemorrhage	0/315 (0%)		1/366 (0.3%)
Investigations
Alanine aminotransferase increased	7/315 (2.2%)		7/366 (1.9%)
Ammonia increased	1/315 (0.3%)		0/366 (0%)
Anticonvulsant drug level increased	2/315 (0.6%)		0/366 (0%)
Aspartate aminotransferase increased	10/315 (3.2%)		6/366 (1.6%)
Blood alkaline phosphatase increased	1/315 (0.3%)		0/366 (0%)
Blood lactate dehydrogenase increased	1/315 (0.3%)		0/366 (0%)
Body temperature fluctuation	0/315 (0%)		1/366 (0.3%)
Eosinophil count increased	1/315 (0.3%)		1/366 (0.3%)
Gamma-glutamyltransferase increased	4/315 (1.3%)		3/366 (0.8%)
Gastrointestinal stoma output increased	0/315 (0%)		1/366 (0.3%)
Hepatic enzyme increased	2/315 (0.6%)		6/366 (1.6%)
International normalised ratio increased	1/315 (0.3%)		0/366 (0%)
Lipase increased	0/315 (0%)		1/366 (0.3%)
Liver function test abnormal	1/315 (0.3%)		2/366 (0.5%)
Norovirus test positive	1/315 (0.3%)		0/366 (0%)
Oxygen consumption increased	0/315 (0%)		1/366 (0.3%)
Oxygen saturation decreased	0/315 (0%)		1/366 (0.3%)
Platelet count decreased	1/315 (0.3%)		0/366 (0%)
Transaminases abnormal	0/315 (0%)		1/366 (0.3%)
Transaminases increased	2/315 (0.6%)		5/366 (1.4%)
Weight decreased	1/315 (0.3%)		4/366 (1.1%)
Metabolism and nutrition disorders
Decreased appetite	0/315 (0%)		3/366 (0.8%)
Dehydration	6/315 (1.9%)		5/366 (1.4%)
Enteral feeding intolerance	0/315 (0%)		1/366 (0.3%)
Failure to thrive	0/315 (0%)		1/366 (0.3%)
Fluid overload	0/315 (0%)		1/366 (0.3%)
Hypercalcaemia	0/315 (0%)		1/366 (0.3%)
Hypernatraemia	0/315 (0%)		2/366 (0.5%)
Hypoglycaemia	0/315 (0%)		1/366 (0.3%)
Hypokalaemia	1/315 (0.3%)		1/366 (0.3%)
Hyponatraemia	1/315 (0.3%)		2/366 (0.5%)
Hypophagia	0/315 (0%)		2/366 (0.5%)
Lactic acidosis	0/315 (0%)		1/366 (0.3%)
Metabolic acidosis	0/315 (0%)		3/366 (0.8%)
Metabolic alkalosis	0/315 (0%)		1/366 (0.3%)
Metabolic disorder	1/315 (0.3%)		0/366 (0%)
Musculoskeletal and connective tissue disorders
Muscular weakness	1/315 (0.3%)		0/366 (0%)
Rhabdomyolysis	0/315 (0%)		1/366 (0.3%)
Nervous system disorders
Altered state of consciousness	1/315 (0.3%)		0/366 (0%)
Ataxia	1/315 (0.3%)		0/366 (0%)
Balance disorder	0/315 (0%)		1/366 (0.3%)
Cerebral atrophy	1/315 (0.3%)		0/366 (0%)
Convulsion	34/315 (10.8%)		44/366 (12%)
Depressed level of consciousness	0/315 (0%)		2/366 (0.5%)
Dyskinesia	1/315 (0.3%)		1/366 (0.3%)
Encephalopathy	0/315 (0%)		1/366 (0.3%)
Epilepsy	2/315 (0.6%)		0/366 (0%)
Generalised tonic-clonic seizure	4/315 (1.3%)		1/366 (0.3%)
Hemiparesis	0/315 (0%)		1/366 (0.3%)
Hypoxic-ischaemic encephalopathy	0/315 (0%)		1/366 (0.3%)
Lethargy	3/315 (1%)		2/366 (0.5%)
Metabolic encephalopathy	0/315 (0%)		1/366 (0.3%)
Movement disorder	0/315 (0%)		1/366 (0.3%)
Myoclonic epilepsy	0/315 (0%)		1/366 (0.3%)
Myoclonus	1/315 (0.3%)		0/366 (0%)
Neuromyopathy	0/315 (0%)		1/366 (0.3%)
Partial seizures	1/315 (0.3%)		0/366 (0%)
Postictal state	1/315 (0.3%)		0/366 (0%)
Sedation	0/315 (0%)		1/366 (0.3%)
Seizure cluster	2/315 (0.6%)		1/366 (0.3%)
Somnolence	2/315 (0.6%)		1/366 (0.3%)
Status epilepticus	47/315 (14.9%)		42/366 (11.5%)
Psychiatric disorders
Abnormal behaviour	2/315 (0.6%)		1/366 (0.3%)
Aggression	1/315 (0.3%)		2/366 (0.5%)
Agitation	0/315 (0%)		1/366 (0.3%)
Anxiety	1/315 (0.3%)		0/366 (0%)
Confusional state	0/315 (0%)		1/366 (0.3%)
Hallucinations, mixed	1/315 (0.3%)		0/366 (0%)
Irritability	0/315 (0%)		1/366 (0.3%)
Mental status changes	1/315 (0.3%)		6/366 (1.6%)
Self injurious behaviour	0/315 (0%)		1/366 (0.3%)
Sleep disorder	1/315 (0.3%)		0/366 (0%)
Renal and urinary disorders
Haematuria	0/315 (0%)		1/366 (0.3%)
Nephrocalcinosis	0/315 (0%)		1/366 (0.3%)
Nephrolithiasis	0/315 (0%)		1/366 (0.3%)
Renal cyst	0/315 (0%)		1/366 (0.3%)
Renal failure acute	1/315 (0.3%)		5/366 (1.4%)
Urinary incontinence	0/315 (0%)		1/366 (0.3%)
Urinary retention	0/315 (0%)		3/366 (0.8%)
Reproductive system and breast disorders
Testicular torsion	0/315 (0%)		1/366 (0.3%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	2/315 (0.6%)		0/366 (0%)
Acute respiratory failure	1/315 (0.3%)		10/366 (2.7%)
Asthma	0/315 (0%)		1/366 (0.3%)
Choking	1/315 (0.3%)		0/366 (0%)
Dyspnoea	2/315 (0.6%)		0/366 (0%)
Epistaxis	0/315 (0%)		1/366 (0.3%)
Hypoxia	0/315 (0%)		9/366 (2.5%)
Increased bronchial secretion	0/315 (0%)		1/366 (0.3%)
Increased upper airway secretion	1/315 (0.3%)		0/366 (0%)
Pleural effusion	0/315 (0%)		1/366 (0.3%)
Pneumonia aspiration	4/315 (1.3%)		16/366 (4.4%)
Pneumonitis	0/315 (0%)		1/366 (0.3%)
Pulmonary embolism	0/315 (0%)		1/366 (0.3%)
Respiratory alkalosis	0/315 (0%)		1/366 (0.3%)
Respiratory distress	1/315 (0.3%)		6/366 (1.6%)
Respiratory failure	2/315 (0.6%)		8/366 (2.2%)
Respiratory tract inflammation	0/315 (0%)		1/366 (0.3%)
Restrictive pulmonary disease	0/315 (0%)		1/366 (0.3%)
Rhinorrhoea	1/315 (0.3%)		0/366 (0%)
Stridor	1/315 (0.3%)		0/366 (0%)
Wheezing	1/315 (0.3%)		0/366 (0%)
Skin and subcutaneous tissue disorders
Excessive granulation tissue	0/315 (0%)		1/366 (0.3%)
Social circumstances
Child abuse	0/315 (0%)		1/366 (0.3%)
Surgical and medical procedures
Foot operation	0/315 (0%)		1/366 (0.3%)
Gastrostomy	0/315 (0%)		1/366 (0.3%)
Vascular disorders
Hypotension	0/315 (0%)		4/366 (1.1%)
Other (Not Including Serious) Adverse Events
	Dravet Syndrome		Lennox-Gastaut Syndrome
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	292/315 (92.7%)		338/366 (92.3%)
Gastrointestinal disorders
Constipation	20/315 (6.3%)		41/366 (11.2%)
Diarrhoea	133/315 (42.2%)		138/366 (37.7%)
Nausea	16/315 (5.1%)		30/366 (8.2%)
Vomiting	63/315 (20%)		99/366 (27%)
General disorders
Fatigue	38/315 (12.1%)		38/366 (10.4%)
Pyrexia	117/315 (37.1%)		123/366 (33.6%)
Infections and infestations
Bronchitis	14/315 (4.4%)		23/366 (6.3%)
Ear infection	35/315 (11.1%)		50/366 (13.7%)
Gastroenteritis	16/315 (5.1%)		6/366 (1.6%)
Gastroenteritis viral	11/315 (3.5%)		29/366 (7.9%)
Influenza	31/315 (9.8%)		42/366 (11.5%)
Nasopharyngitis	78/315 (24.8%)		58/366 (15.8%)
Otitis media	21/315 (6.7%)		21/366 (5.7%)
Pharyngitis streptococcal	24/315 (7.6%)		26/366 (7.1%)
Sinusitis	38/315 (12.1%)		48/366 (13.1%)
Pneumonia	22/315 (7%)		31/366 (8.5%)
Upper respiratory tract infection	77/315 (24.4%)		102/366 (27.9%)
Urinary tract infection	18/315 (5.7%)		47/366 (12.8%)
Viral upper respiratory tract infection	9/315 (2.9%)		19/366 (5.2%)
Injury, poisoning and procedural complications
Contusion	15/315 (4.8%)		24/366 (6.6%)
Fall	20/315 (6.3%)		20/366 (5.5%)
Laceration	8/315 (2.5%)		35/366 (9.6%)
Investigations
Alanine aminotransferase increased	31/315 (9.8%)		23/366 (6.3%)
Aspartate aminotransferase increased	30/315 (9.5%)		13/366 (3.6%)
Gamma-glutamyltransferase increased	29/315 (9.2%)		18/366 (4.9%)
Weight decreased	20/315 (6.3%)		58/366 (15.8%)
Metabolism and nutrition disorders
Decreased appetite	99/315 (31.4%)		92/366 (25.1%)
Nervous system disorders
Convulsion	60/315 (19%)		120/366 (32.8%)
Drooling	11/315 (3.5%)		21/366 (5.7%)
Headache	18/315 (5.7%)		26/366 (7.1%)
Lethargy	19/315 (6%)		32/366 (8.7%)
Sedation	16/315 (5.1%)		27/366 (7.4%)
Somnolence	86/315 (27.3%)		106/366 (29%)
Psychiatric disorders
Abnormal behaviour	32/315 (10.2%)		22/366 (6%)
Aggression	19/315 (6%)		29/366 (7.9%)
Insomnia	16/315 (5.1%)		40/366 (10.9%)
Irritability	26/315 (8.3%)		28/366 (7.7%)
Respiratory, thoracic and mediastinal disorders
Cough	42/315 (13.3%)		63/366 (17.2%)
Nasal congestion	13/315 (4.1%)		46/366 (12.6%)
Rhinorrhoea	19/315 (6%)		19/366 (5.2%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.