Promising Results Announced for an Investigational Drug for Treating Dravet Syndrome

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Friday, October 6, 2017

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.

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Learn more about FAiRE

The goal of FAiRE is to test if ZX008 is a safe and effective treatment for children and adolescents with Dravet syndrome, when added to their other seizure medications.

View the infographic. 

Our Mission

The mission of the Epilepsy Foundation is to lead the fight to overcome the challenges of living with epilepsy and to accelerate therapies to stop seizures, find cures, and save lives.

 
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