JAMA Neurology Publishes Data from Zogenix Phase 3 Trial Evaluating Fintepla in Patients with Dravet Syndrome Taking Stiripentol-Containing Antiepileptic Drug Regimens

JAMA Neurology Publishes Data from Zogenix Phase 3 Trial Evaluating Fintepla in Patients with Dravet Syndrome Taking Stiripentol-Containing Antiepileptic Drug Regimens

Zogenix announced JAMA Neurology, has published the results of Zogenix’s Phase 3 Study 1504 which evaluated Fintepla (ZX008, fenfluramine oral solution) in Dravet syndrome patients whose antiepileptic drug treatment regimens included stiripentol but who were still experiencing a high number of convulsive seizures. The study demonstrated that adding Fintepla to these patients’ treatment regimens led to a significant and clinically meaningful (> 50%) reduction in monthly convulsive seizure frequency (MCSF).

Study 1504 was an international, double-blind, placebo-controlled study of 87 Dravet syndrome patients age 2-19 taking background anti-epileptic drug regimens that included stiripentol. Eligible patients in the trial were experiencing seizures that were poorly controlled with their current anti-seizure medications consisting of stiripentol plus clobazam and/or valproic acid. After a 6-week period to establish baseline seizure frequency, patients were randomized to receive Fintepla starting at a dose of 0.2 mg/kg/day, twice-daily with gradual blinded titration over a 3 week period to 0.4 mg/kg/d (maximum of 17 mg per day) over 3 weeks. Patients maintained their regimen for an a...

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