A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia

Eisai Clinical Trials

Protocol # E2006-G000-201

Study Overview

Study Compound: E2006

Drug Name: lemborexant

Registry #: NCT01995838

Trial Period: Nov 2013 - Apr 2014

Indication: Insomnia

Primary Endpoint:
1. Probability of Having Utility Function Greater Than (>) 1 Based on Bayesian Analysis [ Time Frame: Baseline up to Day 3]

2. Mean Change From Baseline in Karolinska Sleepiness Scale (KSS) Score at End of Treatment [ Time Frame: 1 hour after morning wake time at Baseline and Days 15-16]

Population
Males and females 18 Years to 80 Years (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 2
Countries
United States

Results

CSR Synopsis

Download PDF

Lay Summary

Download PDF

Publication reference citation

Murphy P, Moline M, Mayleben D, Rosenberg R, Zammit G, Pinner K, Dhadda S, Hong Q, Giorgi L, Satlin A. Lemborexant, A Dual Orexin Receptor Antagonist (DORA) for the Treatment of Insomnia Disorder: Results From a Bayesian, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study. J Clin Sleep Med. 2017 Nov 15;13(11):1289-1299. doi: 10.5664/jcsm.6800.

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