Effectiveness of Dayvigo® (Lemborexant) in Participants With Insomnia and Comorbid Anxiety and Depression (LEAD)

Eisai Clinical Trials

Protocol # E2006-M001-611

Study Overview

Study Compound: E2006

Drug Name: lemborexant

Registry #: N/A

Trial Period: Oct 2026 - Aug 2027

Indication: Insomnia and Comorbid Anxiety and Depression

Primary Endpoint: 1. Change from baseline in total Insomnia Severity Index (ISI) score (7 items) at Week 12
2. Change from baseline in Hamilton Depression Rating Scale (HAM-D-17) total score at Week 12
3. Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12

Population
Adult males and females (age 18 and over)
Study Status
Ongoing
Study Phase
Phase N/A
Countries
Canada

Clinical Trial Documents

Clinical Study Report Synopsis

No download available

Plain Language Protocol Synopsis (PLPS)

No download available

Plain Language Summary of Results (PLS)

No download available

Publication reference citation

N/A

Data Sharing

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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