CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
GWP42003-P 20 mg/kg/day Dose +1 moredrug
Likely dose
GWP42003-P 20 mg/kg/day Dosefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02091375
NCT02091375Phase 3Completed
CompareCT.gov

A Double Blind, Placebo Controlled Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

Jazz Pharmaceuticals·interventional·Posted Mar 19, 2014·Updated Sep 28, 2022

In Brief

A Phase 3 clinical trial evaluating GWP42003-P 20 mg/kg/day Dose and Placebo control for Epilepsy and Dravet Syndrome. Completed, enrolled 120 participants across 22 sites in 4 countries.

Detailed Summary

To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Dravet Syndrome
CountriesFrance, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 19, 2014
Enrollment StartMar 30, 2015
Primary CompletionNov 26, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.3 years ago

Interventions

GWP42003-P 20 mg/kg/day Dosedrug

GWP42003-P was an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) dissolved in the excipients, sesame oil and anhydrous ethanol (79 mg/mL), with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).

Placebo controldrug

Placebo oral solution contained the excipients, sesame oil and anhydrous ethanol (79 mg/mL), with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).