Trials / Completed
CompletedNCT05594589
A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Pharmacodynamics of Lemborexant in Korean Subjects With Insomnia Disorder
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of the study is to evaluate the treatment difference between lemborexant 5 milligram (mg) (LEM5) and placebo (PBO) on latency to persistent sleep (LPS) using polysomnography (PSG) on Day 30.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lemborexant | Lemborexant oral tablet. |
| OTHER | PBO | Lemborexant-matched PBO tablet. |
Timeline
- Start date
- 2022-11-30
- Primary completion
- 2024-04-26
- Completion
- 2024-05-24
- First posted
- 2022-10-26
- Last updated
- 2025-07-03
- Results posted
- 2025-07-03
Locations
9 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05594589. Inclusion in this directory is not an endorsement.