UK-based GW Pharmaceuticals has started a Phase III clinical trial of Epidiolex (cannabidiol or CBD) to treat Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy.
The company obtained orphan drug designation from the US Food and Drug Administration (FDA) for Epidiolex to treat LGS in 2014.
GW Pharmaceuticals CEO Justin Gover said: "The commencement of this Phase III pivotal trial of Epidiolex in Lennox-Gastaut syndrome follows on from the recent start of two Phase III pivotal trials of Epidiolex in Dravet syndrome and represents another important milestone towards our planned submission of a NDA to the FDA in 2016.
"Although there are approved treatments available for patients with Lennox-Gastaut syndrome, this severe form of epilepsy often remains particularly difficult to treat. We believe that Epidiolex has the potential to meet this significant unmet need."
The study is a randomised, double-blind and 14-week comparison of Epidiolex against placebo in a total of 150 patients to evaluate the dose-ranging safety and efficacy of the Epidiolex as an adjunctive antiepileptic treatment.
The trial will include three arms of 50 patients, comprising 20mg/kg and 10mg/kg of Epidiolex and placebo.
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According to the company, the primary measure of this study will be the percentage change from baseline.
GW will also analyse several additional efficacy and safety secondary outcome measures of the study and is expected to release top-line data from this trial in early 2016.