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)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Mar 2018

At a glance

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

    • 31 Jan 2018 According to a Zogenix media release, the last patient has been randomized into this trial.
    • 02 Jan 2018 Status changed from recruiting to active, no longer recruiting.
    • 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.
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