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.
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
- 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