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

NCT02350309 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-01-18

Study results available
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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.

Conditions

  • Insomnia Disorder

Interventions

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.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-13
Primary Completion
2015-04-21
Completion
2015-04-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02350309 on ClinicalTrials.gov