NCT02350309

Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder

A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover Study to Evaluate the Effect of 2 Dosage Strengths of E2006 on a Multiple Sleep Latency Test in Subjects With Insomnia Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study will have 2 phases: Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods that taken together, will last up to a maximum of 21 days: a Screening Period and a Baseline Period. The Randomization Phase will comprise 4 treatment periods (Treatment 1, Treatment 2, Treatment 3, Treatment 4) with intervening washout periods between treatment periods (Washout 1, Washout 2, Washout 3). A single dose of study drug will be administered in a randomized, 3-way double-blind crossover manner at Treatment Periods 1-3; flurazepam 30 mg will be administered in an open-label manner at Treatment Period 4.

Conditions

• Insomnia Disorder

Interventions

Type	Name	Description
DRUG	Lemborexant 5 mg	Lemborexant 5 mg tablet.
DRUG	Lemborexant 10 mg	Lemborexant 10 mg tablet.
DRUG	Lemborexant-matched placebo.	Lemborexant-matched placebo tablet.
DRUG	Flurazepam 30 mg	Flurazepam 30 mg capsule.

Timeline

• Start date: 2014-12-13
• Primary completion: 2015-04-21
• Completion: 2015-04-21
• First posted: 2015-01-29
• Last updated: 2020-01-18
• Results posted: 2020-01-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study