A Study of Lemborexant in Chinese Participants With Insomnia Disorder

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

The study will have 2 phases: the Prerandomization Phase and the Randomization Phase. The Prerandomization Phase will comprise 3 periods that will last up to a maximum of 35 days: a Screening Period, a Run-in Period, and a Baseline Period. The Randomization Phase will comprise a Treatment Period during which participants will be treated for 30 nights (1 month) and a minimum 14-day Follow-up Period before an End of Study (EOS) Visit (up to 54 days). The total study duration for each participant on this study is 89 days. ;

Related Conditions & MeSH terms

• Disease
• Sleep Initiation and Maintenance Disorders

• NCT number: NCT04549168
• Study type: Interventional
• Source: Eisai Inc.
• Status: Completed
• Phase: Phase 3
• Start date: November 6, 2020
• Completion date: March 17, 2023