CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
Lemborexant +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05594589
NCT05594589Phase 2Completed
CompareCT.gov

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Pharmacodynamics of Lemborexant in Korean Subjects With Insomnia Disorder

Eisai Co., Ltd.·interventional·Posted Oct 26, 2022·Updated Jul 3, 2025

In Brief

A Phase 2 clinical trial evaluating Lemborexant and PBO for Sleep Initiation and Maintenance Disorders. Completed, enrolled 65 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Initiation and Maintenance Disorders
CountriesSouth Korea
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedOct 26, 2022
Enrollment StartNov 30, 2022
Primary CompletionApr 26, 2024
Study CompletionMay 24, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 3.7 years ago

Interventions

Lemborexantdrug

Lemborexant oral tablet.

PBOother

Lemborexant-matched PBO tablet.