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A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension

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Trial Profile

A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Oct 2023

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At a glance

  • Drugs JZP 258 (Primary)
  • Indications Idiopathic hypersomnia
  • Focus Registrational; Therapeutic Use
  • Sponsors Jazz Pharmaceuticals plc

    • Most Recent Events

    • 23 Oct 2023 Results of exploratory, post-hoc analysis presented in the Jazz Pharmaceuticals Media Release.
    • 31 May 2023 According to a Jazz Pharmaceuticals Inc media release, data from this trial will be presented at the SLEEP 2023, the 37th annual meeting of the Associated Professional Sleep Societies (APSS).
    • 27 Apr 2023 Results assessing the effects of lower-sodium oxybate on 24-Hour total sleep presented at the 75th Annual Meeting of the American Academy of Neurology 2023.
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