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.
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.
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
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
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.
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