drugset / Trial / NCT05594589
A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2022-11-30
- Primary completion
- 2024-04-26
- Completion
- 2024-05-24
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Lemborexant 5 mg; p = 0.0133; Least Squares Geometric Mean(LSGM) Ratio 0.377 (95% CI 0.175 to 0.810); ANCOVA NCT05594589 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lemborexant | Small molecule | 5 mg | Oral |
| Subject | Lemborexant | Small molecule | 10 mg | Oral |