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Last Updated: December 7, 2021

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CLINICAL TRIALS PROFILE FOR LEMBOREXANT

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All Clinical Trials for lemborexant

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01463098 ↗ A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 Completed Eisai Inc. Phase 1 2011-10-05 Part A: The purpose of this study is to evaluate the safety and tolerability of single oral doses of E2006 administered in the morning to healthy male and female subjects. Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects with primary insomnia following single oral dosing of E2006 in the evening approximately 30 minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.
NCT02350309 ↗ Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder Completed Eisai Inc. Phase 1 2014-12-13 This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.
NCT02583451 ↗ Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects Completed Purdue Pharma LP Phase 1 2015-11-01 This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study of lemborexant in healthy adult and elderly subjects to evaluate driving performance
NCT02583451 ↗ Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects Completed Eisai Inc. Phase 1 2015-11-01 This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study of lemborexant in healthy adult and elderly subjects to evaluate driving performance
NCT02783729 ↗ Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1) Completed Eisai Inc. Phase 3 2016-05-31 This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder.
NCT02952820 ↗ Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2) Completed Eisai Inc. Phase 3 2016-11-15 The key objectives of this study are to determine, using sleep diaries, whether lemborexant at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset, subjective sleep efficiency, and subjective sleep maintenance in participants with insomnia disorder.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for lemborexant

Condition Name

Condition Name for lemborexant
Intervention Trials
Insomnia 4
Healthy Subjects 4
Insomnia Disorder 2
Healthy Volunteer 1
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Condition MeSH

Condition MeSH for lemborexant
Intervention Trials
Sleep Initiation and Maintenance Disorders 8
Disease 4
Sleep Apnea, Obstructive 2
Sleep Apnea Syndromes 2
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Clinical Trial Locations for lemborexant

Trials by Country

Trials by Country for lemborexant
Location Trials
United States 92
China 16
Japan 14
Canada 8
United Kingdom 7
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Trials by US State

Trials by US State for lemborexant
Location Trials
Florida 8
Ohio 8
Georgia 7
California 6
Arizona 6
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Clinical Trial Progress for lemborexant

Clinical Trial Phase

Clinical Trial Phase for lemborexant
Clinical Trial Phase Trials
Phase 4 1
Phase 3 4
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for lemborexant
Clinical Trial Phase Trials
Completed 16
Recruiting 4
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Clinical Trial Sponsors for lemborexant

Sponsor Name

Sponsor Name for lemborexant
Sponsor Trials
Eisai Inc. 17
Purdue Pharma LP 9
Eisai Co., Ltd. 2
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Sponsor Type

Sponsor Type for lemborexant
Sponsor Trials
Industry 29
Other 2
NIH 1
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