Trial · NCT02224573

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

NCT02224573, Phase 3, Completed, GW Research Ltd; results first posted 2022-02-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes. Trials, record NCT02224573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02224573

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes
NCT number: NCT02224573
Status: Completed
Phases: Phase 3
Enrollment: 681 participants, actual
Lead sponsor: GW Research Ltd
Conditions: Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
Interventions: GWP42003-P
First posted: 2014-08-25
Last updated: 2022-02-03
Other registries' IDs: eudract:2014-001834-27
Results first posted: 2022-02-03

Source ClinicalTrials.gov

Registered outcomes60

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.

1 to 10 of 60Source ClinicalTrials.gov

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Outcomes60

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group	up to Week 260	Safety Analysis Set: all participants who received at least 1 dose of investigational medicinal product (IMP).	participants	NUMBER
PRIMARY	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	Safety Analysis Set	participants	NUMBER
PRIMARY	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	Safety Analysis Set. Only participants with available data were analyzed.	kilograms per meters squared (kg/m^2)	MEAN
PRIMARY	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	Safety Analysis Set	participants	NUMBER
PRIMARY	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	Safety Analysis Set	participants	NUMBER
PRIMARY	Mean Cannabis Withdrawal Scale Score at End of Taper (EOT), the Post-Taper Safety Call, and at Safety Follow-up	up to Week 260	Safety Analysis Set. Only participants (18 years and above) with available Cannabis Withdrawal Scale score were analyzed.	scores on a scale	MEAN
PRIMARY	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	Safety Analysis Set. Only participants (4 to 17 years) with available Pediatric Cannabis Withdrawal Scale score were analyzed.	scores on a scale	MEAN
PRIMARY	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	Safety Analysis Set. Only participants with available data were analyzed.	10^12 cells per Liter (L)	MEAN
PRIMARY	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Hemoglobin Levels	up to Week 260	Safety Analysis Set. Only participants with available data were analyzed.	grams per Liter (g/L)	MEAN
PRIMARY	Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Hematocrit Values	up to Week 260	Safety Analysis Set. Only participants with available data were analyzed.	percentage of RBCs in whole blood (L/L)	MEAN

1 to 10 of 60Source ClinicalTrials.gov

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Results by group422

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group	Dravet Syndrome	Total participants affected by any TEAE	306	participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group	Lennox-Gastaut Syndrome	Total participants affected by any TEAE	353	participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group	Dravet Syndrome	Diarrhoea	135	participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group	Lennox-Gastaut Syndrome	Diarrhoea	140	participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group	Dravet Syndrome	Vomiting	63	participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group	Lennox-Gastaut Syndrome	Vomiting	107	participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group	Dravet Syndrome	Constipation	20	participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group	Lennox-Gastaut Syndrome	Constipation	43	participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group	Dravet Syndrome	Nausea	16	participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group	Lennox-Gastaut Syndrome	Nausea	32	participants

1 to 10 of 422Source ClinicalTrials.gov

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Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Phase	STARTED	Dravet Syndrome	315
Treatment Phase	STARTED	Lennox-Gastaut Syndrome	366
Treatment Phase	COMPLETED	Dravet Syndrome	170
Treatment Phase	COMPLETED	Lennox-Gastaut Syndrome	243
Treatment Phase	NOT COMPLETED	Dravet Syndrome	145
Treatment Phase	NOT COMPLETED	Lennox-Gastaut Syndrome	123
Taper Phase	STARTED	Dravet Syndrome	79
Taper Phase	STARTED	Lennox-Gastaut Syndrome	71
Taper Phase	COMPLETED	Dravet Syndrome	76
Taper Phase	COMPLETED	Lennox-Gastaut Syndrome	67

1 to 10 of 12Source ClinicalTrials.gov

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Adverse events602

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Constipation	Gastrointestinal disorders	Dravet Syndrome	20	315
other	Constipation	Gastrointestinal disorders	Lennox-Gastaut Syndrome	41	366
other	Diarrhoea	Gastrointestinal disorders	Dravet Syndrome	133	315
other	Diarrhoea	Gastrointestinal disorders	Lennox-Gastaut Syndrome	138	366
other	Nausea	Gastrointestinal disorders	Dravet Syndrome	16	315
other	Nausea	Gastrointestinal disorders	Lennox-Gastaut Syndrome	30	366
other	Vomiting	Gastrointestinal disorders	Dravet Syndrome	63	315
other	Vomiting	Gastrointestinal disorders	Lennox-Gastaut Syndrome	99	366
other	Fatigue	General disorders	Dravet Syndrome	38	315
other	Fatigue	General disorders	Lennox-Gastaut Syndrome	38	366

1 to 10 of 602Source ClinicalTrials.gov

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Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dravet Syndrome	6	315
Total, all-cause mortality	Lennox-Gastaut Syndrome	12	366
Total, other adverse events	Dravet Syndrome	292	315
Total, other adverse events	Lennox-Gastaut Syndrome	338	366
Total, serious adverse events	Dravet Syndrome	133	315
Total, serious adverse events	Lennox-Gastaut Syndrome	157	366

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34287833	DERIVED	PubMed
34406656	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Dravet Syndrome vs Lennox-Gastaut Syndrome: deaths from any cause	Trial comparisons
Dravet Syndrome vs Lennox-Gastaut Syndrome: serious adverse events	Trial comparisons

Tests4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Digit Span Test	Secondary outcome	ConductCognition
Matrix Reasoning	Secondary outcome	ConductCognition
Verbal Fluency	Secondary outcome	ConductCognition
Vocabulary Test	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02224573

GET https://conductscience.org/api/trials/v1/NCT02224573/registered?page=2

API reference For AI assistants