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. |
| NCT03001557 ↗ | Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia | Completed | Purdue Pharma LP | Phase 2 | 2016-12-20 | This study will be conducted to determine the dose response of lemborexant (LEM) on the change from baseline in actigraphy-derived sleep-related parameters, wake-related parameters, and circadian-rhythm related parameters. Following the eligibility screening period, eligible participants will be assigned at random to 1 of 4 doses of LEM or to placebo for 4 weeks. After a 2-week follow-up period, eligible participants may enter an open-label extension period for up to 30 months or until the program discontinuation. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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