A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2)

Trial Profile

A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2017

At a glance

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

    • 07 Nov 2017 According to a Zogenix media release, this trial will be fully enrolled shortly and anticipates announcing top-line data from the trial in the second quarter 2018.
    • 09 Sep 2017 Planned End Date changed from 1 Aug 2017 to 1 Jun 2018.
    • 09 Sep 2017 Planned primary completion date changed from 1 Aug 2017 to 1 Jun 2018.
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