CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 171 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/NCT02224690
NCT02224690Phase 3Completed
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A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults.

Jazz Pharmaceuticals·interventional·Posted Aug 25, 2014·Updated Sep 28, 2022

In Brief

A Phase 3 clinical trial evaluating GWP42003-P 20 mg/kg/day Dose and Placebo for Epilepsy and Lennox-Gastaut Syndrome. Completed, enrolled 171 participants across 24 sites in 3 countries.

Detailed Summary

To evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop seizures when compared with placebo, in participants with Lennox-Gastaut Syndrome (LGS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Lennox-Gastaut Syndrome
CountriesNetherlands, Poland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 25, 2014
Enrollment StartApr 28, 2015
Primary CompletionMar 18, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.9 years ago

Interventions

GWP42003-P 20 mg/kg/day Dosedrug

GWP42003-P was presented as an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) 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).

Placebodrug

Placebo was presented as an oral solution containing 0 mg/mL CBD 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).