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Last Updated: May 15, 2024

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CLINICAL TRIALS PROFILE FOR DAYVIGO


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All Clinical Trials for DAYVIGO

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04555733 ↗ A Single and Multiple Dose Study of Lemborexant in Healthy Chinese Participants Completed Eisai Co., Ltd. Phase 1 2020-10-26 The primary objective of this study is to assess the pharmacokinetics (PK) of lemborexant and metabolites (M4, M9, and M10) in plasma in healthy Chinese participants following single and multiple oral doses of lemborexant.
NCT04818086 ↗ Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder Recruiting National Institute on Drug Abuse (NIDA) Phase 1/Phase 2 2021-05-03 The purpose of this research study is to test the safety, tolerability, drug interactions with buprenorphine-naloxone, and effectiveness lemborexant when used to treat Opioid Use Disorder.
NCT04818086 ↗ Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder Recruiting Virginia Commonwealth University Phase 1/Phase 2 2021-05-03 The purpose of this research study is to test the safety, tolerability, drug interactions with buprenorphine-naloxone, and effectiveness lemborexant when used to treat Opioid Use Disorder.
NCT04890561 ↗ A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women Completed Eisai Inc. Phase 1 2021-05-17 The primary purpose of the study is to estimate the cumulative amount of lemborexant excreted in breast milk following a single dose administration of lemborexant 10 milligram (mg) to healthy lactating women and to estimate the relative infant dose (RID) expressed as a percent of the daily maternal dose.
NCT05344443 ↗ Lemborexant Shift Work Treatment Study Recruiting University of California, San Francisco Phase 4 2022-03-10 Insomnia and daytime sleepiness are common complaints among night shift workers, but effective sleep treatments in shift workers are lacking. The aim of this Phase IV double-blind, placebo-controlled, randomized study is to test whether a dual orexin antagonist, Lemborexant (5mg or 10mg), which would be expected to block the clock-driven orexin-mediated wakefulness during the day, will increase daytime sleep time in shift workers who complain of difficulty sleeping during the daytime compared to placebo.
NCT05458609 ↗ Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep Not yet recruiting Baylor College of Medicine Phase 3 2022-08-06 The purpose of this study to evaluate the effects of naltrexone plus lemborexant augmentation compared to naltrexone plus placebo on cue-induced and non-cued alcohol cravings in people with alcohol use disorder and insomnia. Our secondary goals are to evaluate the effects of lemborexant plus naltrexone combination on sleep quality using self-report questionnaires and actigraph data, depression, anxiety, and suicidal ideation.
NCT05594589 ↗ A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder Not yet recruiting Eisai Co., Ltd. Phase 2 2022-11-30 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for DAYVIGO

Condition Name

Condition Name for DAYVIGO
Intervention Trials
Alcohol Use Disorder 1
Alzheimer Disease 1
Analgesics, Opioid 1
Drug Interaction 1
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Condition MeSH

Condition MeSH for DAYVIGO
Intervention Trials
Opioid-Related Disorders 1
Alzheimer Disease 1
Sleep Initiation and Maintenance Disorders 1
Alcoholism 1
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Clinical Trial Locations for DAYVIGO

Trials by Country

Trials by Country for DAYVIGO
Location Trials
United States 5
China 1
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Trials by US State

Trials by US State for DAYVIGO
Location Trials
Nevada 1
Virginia 1
Missouri 1
Texas 1
California 1
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Clinical Trial Progress for DAYVIGO

Clinical Trial Phase

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

Clinical Trial Status for DAYVIGO
Clinical Trial Phase Trials
Not yet recruiting 3
Completed 2
Recruiting 2
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Clinical Trial Sponsors for DAYVIGO

Sponsor Name

Sponsor Name for DAYVIGO
Sponsor Trials
Eisai Co., Ltd. 2
Eisai Inc. 2
National Institute on Drug Abuse (NIDA) 1
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Sponsor Type

Sponsor Type for DAYVIGO
Sponsor Trials
Industry 4
Other 4
NIH 1
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