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: 08 Aug 2017

At a glance

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

    • 08 Aug 2017 According to a Zogenix media release, the company has enrolled approximately two-thirds of the targeted number of subjects. Enrollment is expected to complete by the end of the current quarter.
    • 27 Apr 2017 According to a Zogenix media release, this trial will enroll 40 subjects per treatment group.
    • 09 Mar 2017 According to a Zogenix media release, data readout expected by end of 2017. An enrollment in Cohort 2 is ongoing.
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