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Last Updated: June 13, 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
NCT02583451 Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects Recruiting 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 Recruiting Eisai Inc. Phase 3 2016-06-01 The primary objective of this study is to demonstrate using polysomnography (PSG) that 10 mg lemborexant is superior to zolpidem tartrate extended release 6.25 mg (Ambien CR®) on objective sleep maintenance as assessed by wake after sleep onset in the second half of the night (WASO2H) after the last 2 nights of treatment in participants 55 years and older with insomnia disorder.
NCT02952820 Long-term Study of Lemborexant in Insomnia Disorder Recruiting Eisai Inc. Phase 3 2016-10-01 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.
NCT03001557 Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia Recruiting Eisai Inc. Phase 2 2016-11-01 This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of lemborexant (4 dose levels) or placebo taken daily for 4 weeks in approximately 125 male or female participants, ages 65 to 90 years, with mild or moderate Alzheimer's disease dementia (AD-D) who complain of disrupted sleep or multiple awakenings at night along with frequent periods of falling asleep during the day that impact the quality of life of the participant. The study is designed to determine whether at least one dose of lemborexant is superior to placebo based on change from baseline in actigraphy Sleep Efficiency and actigraphy Wake Efficiency during the last week of 4 weeks of treatment in participants with Irregular Sleep-Wake Rhythm Disorder and AD-D.
NCT03008447 Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older Recruiting Eisai Inc. Phase 1 2016-11-01 E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change from baseline in postural stability (worsening) when participants are awakened at approximately 4 hours postdose is significantly less after lemborexant than after zolpidem tartrate extended release following a single-dose administration at bedtime.
NCT03158025 A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users Recruiting Purdue Pharma LP Phase 1 2017-04-19 The primary purpose of this study is to evaluate the abuse potential of lemborexant (E2006) in comparison to placebo and 2 controls with known abuse potential (ie, zolpidem and suvorexant) with similar indications (zolpidem and suvorexant) or mechanisms of action (suvorexant).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lemborexant

Condition Name

Condition Name for Lemborexant
Intervention Trials
Healthy Subjects 4
Insomnia 3
Obstructive Sleep Apnea 1
Healthy Volunteer 1
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Condition MeSH

Condition MeSH for Lemborexant
Intervention Trials
Sleep Initiation and Maintenance Disorders 6
Disease 3
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 67
Japan 8
Canada 7
Germany 5
United Kingdom 4
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Trials by US State

Trials by US State for Lemborexant
Location Trials
Florida 7
Ohio 5
New York 5
Georgia 5
California 5
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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
Recruiting 8
Not yet recruiting 6
Completed 3
[disabled in preview] 1
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Clinical Trial Sponsors for Lemborexant

Sponsor Name

Sponsor Name for Lemborexant
Sponsor Trials
Eisai Inc. 15
Purdue Pharma LP 6
Eisai Co., Ltd. 2
[disabled in preview] 3
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Sponsor Type

Sponsor Type for Lemborexant
Sponsor Trials
Industry 24
Other 2
NIH 1
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