A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of Xyrem with an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects with Narcolepsy with Cataplexy

Trial Profile

A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of Xyrem with an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects with Narcolepsy with Cataplexy

Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Sodium oxybate (Primary)
  • Indications Cataplexy; Narcolepsy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms EXPRESS
  • Sponsors Jazz Pharmaceuticals Inc
  • Most Recent Events

    • 24 Apr 2017 Results were published in a Jazz Pharmaceuticals Media Release.
    • 24 Apr 2017 According to a Jazz Pharmaceuticals media release, data will be presented at at the 31st Annual Meeting of the Associated Professional Sleep Societies LLC (APSS).
    • 04 Oct 2016 Planned End Date changed from 1 Nov 2017 to 1 Dec 2017.
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