A study in patients with idiopathic hypersomnia involving two parts. Part A is an an open-label study to assess safety, tolerability and pharmacokinetics of a single oral GR3027 dose in female patients. Part B is 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.
- Registry ID
- EUCTR2017-002127-16
- Source registry
- EUCTR
- Status
- Completed
- Phase
- PHASE2
- Sponsor
- Umecrine Cognition AB
- Start date
- 2017-08-24
- Completion date
- 2018-10-19
- Last update
- 2026-08-16
Conditions
- Idiopathic hypersomnia (IH)
Summary
Part A: The primary objective is to assess the safety and tolerability of GR3027 after a single oral dose of GR3027 in female patients with IH.
Part B: The primary objective is to assess the safety and tolerability of GR3027 after multiple dose administration in patients with IH.
Locations
- , , Denmark
- , , Finland
- , , Sweden
View on source registry