Trial · NCT02224703

GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

NCT02224703, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2019-08-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome. Trials, record NCT02224703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02224703

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Trial

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

Title: GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome
NCT number: NCT02224703
Status: Completed
Phases: Phase 3
Enrollment: 199 participants, actual
Lead sponsor: Jazz Pharmaceuticals
Conditions: Epilepsy, Dravet Syndrome
Interventions: GWP42003-P, Placebo Control
First posted: 2014-08-25
Last updated: 2022-09-28
Other registries' IDs: eudract:2014-002939-34
Results first posted: 2019-08-01

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Change In Convulsive Seizures During The Treatment Period Compared To Baseline	Baseline to Day 99 or Early Termination (ET)	Convulsive seizures were defined as tonic-clonic, tonic, clonic, or atonic. Participants or their caregivers recorded the number and type of convulsive seizures each day from screening until completion of dosing using an interactive voice response system (IVRS) diary. The primary endpoint was analyzed using negative binomial regression on the sum of the convulsive seizure counts during the treatment period, based on the ITT analysis set. Baseline included all available data prior to Day 1. Data reported as the ratio of geometric least squares mean in convulsive seizures and expressed as a percentage reduction.
Secondary	Change In Total Seizures During The Treatment Period Compared To Baseline	Baseline to Day 99 or ET	Total seizures were defined as the combination of convulsive and non-convulsive seizures. Convulsive seizures were defined as tonic-clonic, tonic, clonic, or atonic seizures. Non-convulsive seizures were defined as myoclonic, countable partial, other partial, or absence seizures. Participants or their caregivers recorded the number and type of convulsive seizures and non-convulsive seizures each day from screening until completion of dosing using an IVRS diary. Change compared to baseline was calculated as per the primary outcome measure. Data reported as the ratio of geometric least squares mean in total seizures and expressed as a percentage reduction.
Secondary	Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period	Baseline to Day 99 or ET	Convulsive seizures were defined as tonic-clonic, tonic, clonic, or atonic. Participants or their caregivers recorded the number and type of convulsive seizures each day from screening until completion of dosing using an IVRS diary. Baseline included all available data prior to Day 1 (28-day average). Percentage change from baseline was calculated as: (\[frequency during the treatment period - frequency during baseline\]/frequency during baseline) x 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) x 28. Baseline included all available data prior to Day 1 (28-day average).
Secondary	Caregiver Global Impression Of Change (CGIC) At The Last Visit	Baseline to Last Visit	On Day 1 (prior to receiving study drug), the caregiver was asked to write a brief description of the participant's overall condition as a memory aid for the CGIC questionnaire at subsequent visits. The CGIC questionnaire comprised the following question, to be rated on a 7-point scale: Since your child started treatment, please assess the status of your child's overall condition (comparing their condition now to their condition before treatment) using the scale below. The markers were: "Very Much Improved"; "Much Improved"; "Slightly Improved"; "No Change"; "Slightly Worse"; "Much Worse"; "Very Much Worse". The CGIC response/score, recorded at each visit, was summarized, on both a categorical and continuous scale, by treatment group. The scores at the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant's last evaluation was performed were analyzed using ordinal logistic regression.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change In Convulsive Seizures During The Treatment Period Compared To Baseline	Baseline to Day 99 or Early Termination (ET)	Intention-to-treat (ITT) analysis set: All participants who were randomized and dosed in the trial and had post-baseline efficacy data.	percentage reduction	GEOMETRIC_LEAST_SQUARES_MEAN
SECONDARY	Change In Total Seizures During The Treatment Period Compared To Baseline	Baseline to Day 99 or ET	Intention-to-treat (ITT) analysis set: All participants who were randomized and dosed in the trial and had post-baseline efficacy data.	percentage reduction	GEOMETRIC_LEAST_SQUARES_MEAN
SECONDARY	Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period	Baseline to Day 99 or ET	Intention-to-treat (ITT) analysis set: All participants who were randomized and dosed in the trial and had post-baseline efficacy data.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Caregiver Global Impression Of Change (CGIC) At The Last Visit	Baseline to Last Visit	Intention-to-treat (ITT) analysis set: All participants who were randomized and dosed in the trial and had post-baseline efficacy data.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group30

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

Outcome	Group	Category	Value	Spread	Units
Change In Convulsive Seizures During The Treatment Period Compared To Baseline	10 mg/kg/Day GWP42003-P		48.7	95% Confidence Interval 37.9 to 57.6	percentage reduction
Change In Convulsive Seizures During The Treatment Period Compared To Baseline	20 mg/kg/Day GWP42003-P		45.7	95% Confidence Interval 34.2 to 55.2	percentage reduction
Change In Convulsive Seizures During The Treatment Period Compared To Baseline	Placebo Control		26.9	95% Confidence Interval 11.9 to 39.4	percentage reduction
Change In Total Seizures During The Treatment Period Compared To Baseline	10 mg/kg/Day GWP42003-P		56.4	95% Confidence Interval 47.8 to 63.6	percentage reduction
Change In Total Seizures During The Treatment Period Compared To Baseline	20 mg/kg/Day GWP42003-P		47.3	95% Confidence Interval 36.9 to 56.0	percentage reduction
Change In Total Seizures During The Treatment Period Compared To Baseline	Placebo Control		29.7	95% Confidence Interval 16.0 to 41.1	percentage reduction
Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period	10 mg/kg/Day GWP42003-P		29		Participants
Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period	20 mg/kg/Day GWP42003-P		33		Participants
Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period	Placebo Control		17		Participants
Caregiver Global Impression Of Change (CGIC) At The Last Visit	10 mg/kg/Day GWP42003-P	Very Much Improved	13		Participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	10 mg/kg/Day GWP42003-P	67
Overall Study	STARTED	20 mg/kg/Day GWP42003-P	67
Overall Study	STARTED	Placebo Control	65
Overall Study	Received at Least 1 Dose of Study Drug	10 mg/kg/Day GWP42003-P	66
Overall Study	Received at Least 1 Dose of Study Drug	20 mg/kg/Day GWP42003-P	67
Overall Study	Received at Least 1 Dose of Study Drug	Placebo Control	65
Overall Study	Safety Analysis Set	10 mg/kg/Day GWP42003-P	64
Overall Study	Safety Analysis Set	20 mg/kg/Day GWP42003-P	69
Overall Study	Safety Analysis Set	Placebo Control	65
Overall Study	Intent to Treat (ITT) Analysis Set	10 mg/kg/Day GWP42003-P	66

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events144

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	Diarrhoea	Gastrointestinal disorders	10 mg/kg/Day GWP42003-P	11	64
other	Diarrhoea	Gastrointestinal disorders	20 mg/kg/Day GWP42003-P	18	69
other	Diarrhoea	Gastrointestinal disorders	Placebo Control	8	65
other	Vomiting	Gastrointestinal disorders	10 mg/kg/Day GWP42003-P	4	64
other	Vomiting	Gastrointestinal disorders	20 mg/kg/Day GWP42003-P	11	69
other	Vomiting	Gastrointestinal disorders	Placebo Control	4	65
other	Pyrexia	General disorders	10 mg/kg/Day GWP42003-P	15	64
other	Pyrexia	General disorders	20 mg/kg/Day GWP42003-P	14	69
other	Pyrexia	General disorders	Placebo Control	11	65
other	Fatigue	General disorders	10 mg/kg/Day GWP42003-P	5	64

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	10 mg/kg/Day GWP42003-P	0	64
Total, all-cause mortality	20 mg/kg/Day GWP42003-P	0	69
Total, all-cause mortality	Placebo Control	0	65
Total, other adverse events	10 mg/kg/Day GWP42003-P	56	64
Total, other adverse events	20 mg/kg/Day GWP42003-P	60	69
Total, other adverse events	Placebo Control	58	65
Total, serious adverse events	10 mg/kg/Day GWP42003-P	13	64
Total, serious adverse events	20 mg/kg/Day GWP42003-P	17	69
Total, serious adverse events	Placebo Control	10	65

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32119035	DERIVED	PubMed
34265088	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 comparisons0

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

None in this release.

Tests0

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

None in this release.

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.

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