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A phase IIa study of GR3027 in patients with idiopathic hypersomnia (IH) involving an open-label part to assess safety, tolerability and pharmacokinetics (PK) of a single oral GR3027 dose in female patients and a randomized, double-blind, placebo-controlled crossover study to assess safety, tolerability, exposure and exploratory efficacy of multiple oral doses of GR3027 in male and female IH patients.

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Trial Profile

A phase IIa study of GR3027 in patients with idiopathic hypersomnia (IH) involving an open-label part to assess safety, tolerability and pharmacokinetics (PK) of a single oral GR3027 dose in female patients and a randomized, double-blind, placebo-controlled crossover study to assess safety, tolerability, exposure and exploratory efficacy of multiple oral doses of GR3027 in male and female IH patients.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 18 Dec 2018

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At a glance

  • Drugs Golexanolone (Primary)
  • Indications Hypersomnia
  • Focus Adverse reactions
  • Sponsors Umecrine Cognition

    • Most Recent Events

    • 06 Dec 2018 Status changed from recruiting to completed.
    • 22 Mar 2018 Planned End Date changed from 24 May 2018 to 24 Aug 2018.
    • 04 Sep 2017 New trial record
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