Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

December 20, 2016

Primary Completion Date

July 26, 2018

Study Completion Date

April 17, 2020

Conditions
Irregular Sleep-Wake Rhythm Disorder
Interventions
DRUG

Lemborexant 2.5 mg

Lemborexant 2.5 mg tablets

DRUG

Lemborexant 5 mg

Lemborexant 5 mg tablets

DRUG

Lemborexant 10 mg

Lemborexant 10 mg tablets

DRUG

Lemborexant 15 mg

Lemborexant 5 mg and 10 mg tablets

DRUG

Lemborexant-matched placebo

Lemborexant-matched placebo tablets

Trial Locations (48)

19090

Facility #1, Willow Grove

19401

Facility #1, Norristown

27612

Facility #1, Raleigh

27705

Facility #2, Durham

28270

Facility #1, Charlotte

29203

Facility #1, Columbia

30331

Facility #1, Atlanta

31201

Facility #1, Macon

31909

Facility #1, Columbus

32806

Facility #1, Orlando

Facility #2, Orlando

33009

Facility #1, Hallandale

33014

Facility #1, Miami Lakes

33016

Facility #1, Miami Springs

33137

Facility #1, Miami

33165

Facility #1, Miami

33351

Facility #1, Sunrise

33511

Facility #1, Brandon

33613

Facility #2, Tampa

34205

Facility #1, Bradenton

34601

Facility #1, Brooksville

67207

Facility #1, Wichita

72205

Facility #1, Little Rock

72758

Facility #1, Rogers

89104

Facility #1, Las Vegas

90404

Facility #1, Santa Monica

91206

Facility #1, Glendale

92103

Facility #1, San Diego

92614

Facility #1, Irvine

92618

Facility #1, Irvine

92626

Facility #1, Costa Mesa

92835

Facility #1, Fullerton

92037-0949

Facility #1, La Jolla

02478

Facility #1, Belmont

Unknown

Nevada Senior Services (NSS) Adult Day Care Center, Henderson

08755

Facility #1, Toms River

Facility #2, Toms River

451-8511

Eisai Trial Site #1, Nagoya

251-0038

Eisai Trial Site #1, Fujisawa

210-0852

Eisai Trial Site #1, Kawasaki-shi

351-0111

Eisai Trial Site #1, Wako

187-8551

Eisai Trial Site #1, Kodaira

156-0041

Eisai Trial Site #1, Setagaya City

169-0073

Eisai Trial Site #1, Shinjuku

190-8531

Eisai Trial Site #1, Tachikawa-shi

BN1 9PX

Brighton and Sussex Medical School, Brighton

TN6 1NY

Cognitive Treatment and Research Unit, Crowborough

EH1 64UX

University of Edinburgh - PPDS, Edinburgh

All Listed Sponsors
collaborator

Purdue Pharma LP

INDUSTRY

lead

Eisai Inc.

INDUSTRY

NCT03001557 - Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia | Biotech Hunter | Biotech Hunter