A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of the Efficacy and Safety of Lemborexant in Subjects With Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia

Eisai Clinical Trials

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of the Efficacy and Safety of Lemborexant in Subjects With Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer’s Disease Dementia

Protocol # E2006-G000-202

Study Overview

Study Compound: E2006

Drug Name: lemborexant

Registry #: NCT03001557, 2017-003306-40, jRCT2080223437, JAPICCTI-173492

Trial Period: Dec 2016 - Apr 2020

Indication: Irregular Sleep-Wake Rhythm Disorder

Primary Endpoint:
1. Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment [Time Frame: Baseline, Week 1]

2. Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 2 of Treatment [Time Frame: Baseline, Week 2]

3. Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 3 of Treatment [Time Frame: Baseline, Week 3]

Population
Males and females 60 Years to 90 Years (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 2
Countries
Japan, United Kingdom, United States See moreSee less

Results

CSR Synopsis

Download PDF

Lay Summary

Download PDF

Publication reference citation

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

CSDR Sharing is not available for this study.

CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR