Add-on oral treatment with Epidiolex (cannabidiol) significantly lowered the frequency of convulsive seizures in patients with Dravet syndrome, according to topline results of a Phase 3 clinical trial.
The study (NCT02224703) was the second double-blind, placebo-controlled Phase 3 clinical trial of GW Pharmaceuticals’ Epidiolex in the treatment of Dravet-associated seizures. It included 199 patients ages 2-18 (average age 9) and currently uncontrolled on one or more concomitant anti-epileptic medications (AEDs). On average, the patients were taking three AEDs and had discontinued four other such therapies.
The patients were randomly assigned to add-on treatment with Epidiolex at 20 mg/kg/day (67 patients), 10 mg/kg/day (67) or placebo (65). Epidiolex’s dose was adjusted during the first two weeks, then maintained for 12 weeks. The median monthly baseline convulsive seizure frequency was 12, while median total seizure frequency per month was 35.
Results showed that, over the 14-week treatment period, patients on the