Zogenix, Inc. recently reported positive results for its Phase 3 clinical trial for the drug ZX008 (low-dose fenfluramine hydrochloride) for treating Dravet syndrome. The trial showed that at a dose of 0.8 mg/kg/day, ZX008 performed better as an add-on seizure medication compared to a placebo for changing the number of monthly convulsive (for example, tonic clonic) seizures. A higher proportion of participants on this dose also had reductions in seizure frequency and experienced longer seizure-free periods. ZX008 also showed improvement over a placebo at a dose of 0.2 mg/kg/day.
More Information on the Study
- The study included 119 participants across the United States, Canada, Europe, and Australia
- Median age of participants was 8 years
- Participants were placed into three treatment groups where either ZX008 0.8 mg/kg/day, ZX008 0.2 mg/kg/day, or a placebo was added to their current therapies. Participants remained at a fixed dose for 12 weeks.
- Participants on the 0.8 dose had a 63.9% reduction in average monthly seizures compared to the placebo. Participants on the 0.2 dose had 33.7% reduction in average monthly seizures.
- Both non-placebo groups experienced adverse events more often than the placebo group (95% vs. 65%).
Join a Clinical Trial
The Fenfluramine Assessment in Rare Epilepsy (FAiRE) clinical trials are currently recruiting children and young adults with Dravet syndrome.