Phase 3
N=199
GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome
Epilepsy · Dravet Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02224703 ↗Enrolled (actual)
199
Serious AEs
20.2%
Results posted
Aug 2019
Primary outcome: Primary: Change In Convulsive Seizures During The Treatment Period Compared To Baseline — 48.7; 45.7; 26.9 percentage reduction — p=0.0299
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GWP42003-P (Drug); Placebo Control (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Jazz Pharmaceuticals
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change In Convulsive Seizures During The Treatment Period Compared To Baseline |
48.7; 45.7; 26.9 | 0.0299 sig |
| SECONDARY Change In Total Seizures During The Treatment Period Compared To Baseline |
56.4; 47.3; 29.7 | 0.0255 sig |
| SECONDARY Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period |
29; 33; 17 | 0.0069 sig |
| SECONDARY Caregiver Global Impression Of Change (CGIC) At The Last Visit |
13; 11; 1; 11; 10; 8 | 0.0279 sig |
Summary
To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
Eligibility Criteria
Key Inclusion Criteria
- Participant must have been male or female, aged between 2 and 18 years (inclusive).
- Participant must have had a documented history of Dravet syndrome that was not completely controlled by current antiepileptic drugs.
- Participant must have been taking 1 or more antiepileptic drugs at a dose that had been stable for at least 4 weeks.
- All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation) must have been stable for 4 weeks prior to screening and participant was willing to maintain a stable regimen throughout the study.
Key Exclusion Criteria
- Participant had clinically significant unstable medical conditions other than epilepsy.
- Participant had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or randomization, other than epilepsy.
- Participant was currently using or had in the past used recreational cannabis, medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to study entry and was unwilling to abstain for the duration for the study.
- Participant had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products.
- There were plans for the participant to travel outside their country of residence during the study.
- Any history of suicidal behavior or any suicidal ideation of type four or five on the Columbia-Suicide Severity Rating Scale (Children's) at screening.
Data sourced from ClinicalTrials.gov (NCT02224703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.