CLINICAL TRIALS PROFILE FOR DAYVIGO
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All Clinical Trials for DAYVIGO
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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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 | >Sponsor | >Phase | >Start Date | >Summary |
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