At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 194 enrolled
Drug / intervention
Lemborexant +1 moredrug
Likely dose
Lemborexant 10 mgfrom 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.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of the Efficacy and Safety of Lemborexant in Chinese Subjects With Insomnia Disorder
In Brief
A Phase 3 clinical trial evaluating Lemborexant and Placebo for Sleep Initiation and Maintenance Disorders. Completed, enrolled 194 participants across 23 sites in 2 countries.
Detailed Summary
The primary purpose of this study is to confirm using polysomnography (PSG) that lemborexant 10 milligram (mg) is superior to placebo on objective sleep onset as assessed by latency to persistent sleep (LPS) during the last 2 nights of 1 month of treatment in participants with insomnia disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartNov 2020
Primary CompletionMar 2023
TodayJul 2026
First PostedSep 16, 2020
Enrollment StartNov 6, 2020
Primary CompletionMar 17, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.8 years ago
Interventions
Lemborexantdrug
Lemborexant 10 mg tablet.
Placebodrug
Placebo tablet matched to lemborexant 10 mg tablet.