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A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder

NCT05594589 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-07-03

Study results available
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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.

Conditions

  • Sleep Initiation and Maintenance Disorders

Interventions

DRUG

Lemborexant

Lemborexant oral tablet.

OTHER

PBO

Lemborexant-matched PBO tablet.

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2024-04-26
Completion
2024-05-24

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05594589 on ClinicalTrials.gov