CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 225 enrolled
Drug / intervention
GWP42003-P +1 moredrug
Likely dose
GWP42003-P 100 mgfrom 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/NCT02224560
NCT02224560Phase 3Completed
CompareCT.gov

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 and Placebo control for Epilepsy and Lennox Gastaut Syndrome. Completed, enrolled 225 participants across 29 sites in 4 countries.

Detailed Summary

The primary objective of this study was 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
CountriesFrance, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 25, 2014
Enrollment StartJun 8, 2015
Primary CompletionMay 19, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.9 years ago

Interventions

GWP42003-Pdrug

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). Participants were randomly assigned to receive either 10 or 20 mg/kg/day.

Placebo controldrug

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).