A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease

PHASE1CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

January 6, 2021

Primary Completion Date

February 10, 2022

Study Completion Date

February 10, 2022

Conditions
Sleep Apnea, ObstructivePulmonary Disease, Chronic ObstructiveRespiration Disorders
Interventions
DRUG

Placebo

OSA: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.

DRUG

Lemborexant 10 mg

OSA: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.

DRUG

Placebo

COPD: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.

DRUG

Lemborexant 10 mg

COPD: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.

Trial Locations (11)

30328

NeuroTrials Research Inc., Atlanta

31605

GNP Research, Valdosta

32789

Clinical Site Partners Orlando, LLC, Winter Park

33024

Research Centers of America, Hollywood

33186

Clinical Trials of Florida, LLC, Miami

33511

Teradan Clinical Trials, Brandon

33765

St. Francis Medical Institute, Clearwater

45212

CTI Clinical Trial & Consulting Services, Cincinnati

45245

Intrepid Research, LLC, Cincinnati

85306

Pulmonary Associates, Glendale

92103

Pacific Research Network, San Diego

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT04647383 - A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease | Biotech Hunter | Biotech Hunter