A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome

Trial Profile

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome

Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2018

At a glance

  • Drugs Fenfluramine (Primary)
  • Indications Dravet syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors Zogenix
  • Most Recent Events

    • 09 Mar 2027 Study 1 is a merged study analysis whereby top-line results from the first half of the combined patient population of studies 1501 and 1502 would be reported as Study 1 which will include the first 120 patients, and potentially Study 2 for the remaining patients. ( Reference: https://baystreet.ca/articles/research_reports/lifesci/Zogenix021517.pdf and http://ir.zogenix.com/phoenix.zhtml?c=220862&p=irol-SECText&TEXT)
    • 06 Feb 2018 According to a Zogenix Media release, based on the efficacy and safety results of this study, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ZX008 (low-dose fenfluramine), for the treatment of seizures associated with Dravet syndrome.
    • 05 Dec 2017 Results (n=119) presented at the 71st Annual Meeting of the American Epilepsy Society.
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