UK-based GW Pharmaceuticals has started a Phase II/III clinical trial of Epidiolex (cannabidiol or CBD) to treat Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy.
The Phase II/III trial is a two-part randomised double-blind, placebo-controlled parallel group safety, tolerability, pharmacokinetic and efficacy trial designed to evaluate single and multiple doses of Epidiolex in children with Dravet syndrome who are being treated with other anti-epileptic drugs.
Part one of the trial includes the pharmacokinetic and dose-finding elements in a total of 30 patients over a three-week treatment period, while the second part is a placebo-controlled safety and efficacy evaluation of Epidiolex over a three-month treatment period in a total of 80 patients.
The company said that all patients who complete the Phase II/III trial will be eligible to receive Epidiolex under a long-term open label extension trial.
NYU School of Medicine professor of Neurology, Neurosurgery, and Psychiatry and principal Investigator of the trial Orrin Devinsky said: "The results of our open-label trial of Epidiolex in children with Dravet syndrome have been very encouraging and we are excited to begin this important placebo-controlled clinical trial."
GW chief executive officer Justin Gover said: "Epidiolex is the first plant-based CBD medicine to be studied in a FDA-authorised, placebo-controlled trial and we look forward to working with leading paediatric epilepsy centres across the US to advance this clinical program as rapidly as possible."
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An additional Phase III trial in Dravet syndrome is expected to be started in the first quarter of 2015 in parallel with part two of the first Phase II/III trial.
In the first quarter of 2015, the company intends to begin two Phase III clinical trials in Lennox-Gastaut syndrome.