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

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 21, 2016

Primary Completion Date

January 3, 2018

Study Completion Date

January 3, 2018

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.

Trial Locations (4)

10019

Clinilabs, Inc, New York

27612

Wake Research Assoicates, LLC, Raleigh

30342

NeuroTrials Research, Inc, Atlanta

45212

Community Research Management Associates d/b/a CTI Clinical Research Center, Cincinnati

All Listed Sponsors
collaborator

Purdue Pharma LP

INDUSTRY

lead

Eisai Inc.

INDUSTRY

NCT03008447 - 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 | Biotech Hunter | Biotech Hunter