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Clinical Trial Summary

This study will be conducted to determine the dose response of lemborexant (LEM) on the change from baseline in actigraphy-derived sleep-related parameters, wake-related parameters, and circadian-rhythm related parameters. Following the eligibility screening period, eligible participants will be assigned at random to 1 of 4 doses of LEM or to placebo for 4 weeks. After a 2-week follow-up period, eligible participants may enter an open-label extension period for up to 30 months or until the program discontinuation.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT03001557
Study type Interventional
Source Eisai Inc.
Status Completed
Phase Phase 2
Start date December 20, 2016
Completion date April 17, 2020