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Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older

NCT03008447 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-08-01

No results posted yet for this study

Summary

E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change from baseline in postural stability (worsening) when participants are awakened at approximately 4 hours postdose is significantly less after lemborexant than after zolpidem tartrate extended release following a single-dose administration at bedtime.

Conditions

  • Healthy Subjects

Interventions

DRUG

LEM5

Single dose of lemborexant 5 mg administered within 5 minutes before bedtime.

DRUG

LEM10

Single dose of lemborexant 10 mg administered within 5 minutes before bedtime.

DRUG

ZOL

Single dose of zolpidem 6.25 mg administered within 5 minutes before bedtime.

DRUG

PBO

Single dose of placebo administered within 5 minutes before bedtime.

Sponsors & Collaborators

  • Purdue Pharma LP

    collaborator INDUSTRY

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-21
Primary Completion
2018-01-03
Completion
2018-01-03
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 NCT03008447 on ClinicalTrials.gov