Epilepsy (Pediatric)

December 11, 2017

Zogenix announced data from its phase III trial (Study 1) of ZX008 (low-dose fenfluramine hydrochloride) for Dravet syndrome. The randomized, double blind, placebo-controlled study enrolled 119 patients across sites in the U.S., Canada, Europe and Australia. The median age of patients was 8 years (range, 2-18 years). Following a six-week baseline observation period, patients were randomized to one of three treatment groups: ZX008 0.8mg/kg/day (30mg maximum daily dose; n=40), ZX008 0.2mg/kg/day (n=39) and placebo (n=40) in which ZX008 or placebo was added to current regimens of antiepileptic drugs. Patients were titrated to their target dose over two weeks and then remained at that fixed dose for 12 weeks. The mean baseline convulsive seizure frequency across the study groups was approximately 40 seizures per month.

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