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NCT02091375 · ClinicalTrials.gov registry record · Phase 3
Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)
A Phase 3 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
NCT02091375: Completed Phase 3 study, sponsored by Jazz Pharmaceuticals.
NCT02091375 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 120 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02091375, a Phase 3 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
Study Summary
To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
Primary Outcome
Convulsive seizures (atonic, clonic, tonic, or tonic-clonic) were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. Percentage change from baseline was calculated as: (\[frequency during the treatment period - frequency during baseline\]/frequency during baseline) \* 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) \* 28. Baseline incl
Interventions
- DRUG Placebo control
- DRUG GWP42003-P 20 mg/kg/day Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2015-03-30 |
| Est. Completion | 2015-11-26 |
| Phase | Phase 3 |
What the finished NCT02091375 record still lists
NCT02091375 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo control is the first listed.
NCT02091375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02091375 about?
NCT02091375 is a clinical study titled "Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)". To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
What is the current status of trial NCT02091375?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2015-03-30. Estimated completion is 2015-11-26.
What interventions are being tested in trial NCT02091375?
The interventions under investigation include: Placebo control (DRUG), GWP42003-P 20 mg/kg/day Dose (DRUG).
Who is sponsoring clinical trial NCT02091375?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02091375's enrollment target sits among peer trials
120 1619th of 2000 higher than 361 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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