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: 29 Sep 2017

At a glance

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

    • 29 Sep 2017 Top-line results of study 1 (prospective merged analysis of two identical trials ZX008-1501 and ZX008-1502; n=119) published in the Zogenix media release.
    • 09 Sep 2017 Planned End Date changed from 1 Sep 2017 to 1 Jun 2018.
    • 09 Sep 2017 Planned primary completion date changed from 1 Sep 2017 to 1 Jun 2018.
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