CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 69 enrolled
Drug / intervention
Lemborexant 5 mg +3 moredrug
Likely dose
Lemborexant 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02350309
NCT02350309Phase 1Completed

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

Eisai Inc.·interventional·Posted Jan 29, 2015·Updated Jan 18, 2020

In Brief

A Phase 1 clinical trial evaluating Lemborexant 5 mg, Lemborexant 10 mg, and 2 other interventions for Insomnia Disorder. Completed, enrolled 69 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 29, 2015
Enrollment StartDec 13, 2014
Primary CompletionApr 21, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.4 years ago

Interventions

Lemborexant 5 mgdrug

Lemborexant 5 mg tablet.

Lemborexant 10 mgdrug

Lemborexant 10 mg tablet.

Lemborexant-matched placebo.drug

Lemborexant-matched placebo tablet.

Flurazepam 30 mgdrug

Flurazepam 30 mg capsule.