GW Research: A Study to Investigate the Efficacy and Safety of Cannabidiol as Adjunctive Treatment for Lennox-Gastaut Syndrome in Children and Adults
A 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
Since 2013, a consortium of 10 epilepsy centers has been collecting prospective data on children and young adults with severe epilepsy who are receiving Epidiolex, a purified cannabis extract containing 99% cannabidiol and less than 0.10% Δ9-THC (GW Pharmaceuticals), through an expanded-access program authorized by the Food and Drug Administration (FDA). A preliminary report from this open-label study, initiated by investigators to assess the safety and dosing of cannabidiol, noted that among 137 patients who had received at least 12 weeks of treatment, the median reduction in the number of seizures was 54%. 41 Randomized clinical trials of Epidiolex are now being conducted for the treatment of two forms of severe, childhood onset epilepsy: Dravet’s syndrome (a severe myoclonic epilepsy of infancy) (NCT02091375) and the Lennox–Gastaut syndrome (a childhood-onset, treatment-resistant epilepsy characterized by multiple types of seizures and developmental delay) (NCT02224690).