Epidiolex (cannabidiol) enters Phase III trial for Lennox-Gastaut syndrome- GW Pharma

GW Pharmaceuticals has commenced a Phase III clinical trial of Epidiolex (cannabidiol or CBD) for the treatment of Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. This Phase III pivotal trial is a randomized, double-blind, 14-week comparison of Epidiolex versus placebo in a total of 150 patients to assess the dose-ranging safety and efficacy of Epidiolex as an adjunctive antiepileptic treatment. The treatment period will consist of a two-week titration period followed by a 12-week maintenance period.

This Phase 3 trial will have three arms of 50 patients; 20mg/kg and 10mg/kg of Epidiolex and placebo. The primary measure of this trial will be the percentage change from baseline in number of drop seizures in patients taking Epidiolex versus placebo. Several additional efficacy and safety secondary outcome measures will be analysed. Following their participation in the study, all patients are eligible to receive Epidiolex under a long term open label extension study.

Comment: Epidiolex is already in an ongoing trial for Dravet syndrome. Results of the trials are expected in early 2016.