Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause

Phase 3

Completed

• Conditions: Insomnia
• Interventions: Drug: Placebo; Drug: Eszopiclone

• Registration Number: NCT00366093
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary

To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or menopause following treatment with 3 mg of eszopiclone.

Detailed Description

A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of eszopiclone 3 mg in women with insomnia secondary to perimenopause or menopause. Eligible subjects will be randomized to either eszopiclone 3 mg or placebo nightly for four weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-17
• Study First Posted: 2006-08-18
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 410

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo tablet
1	Eszopiclone	eszopiclone 3 mg

Primary Outcome Measures

Name	Time	Method
mean subjective SL	Week 1

Secondary Outcome Measures

Name	Time	Method
MenQOL score	Week 4
MADRS score	Week 4
Physician Global Assessment	Week 4
mean subjective WASO	Week 1
Mean subjective SL	Weeks 2, 3, 4
Mean subjective WASO	Weeks 2, 3, 4
Mean subjective TST	Weeks 1, 2, 3, 4
Mean number of awakenings	Weeks 1, 2, 3, 4
Sleep quality and depth	Weeks 1, 2, 3, and 4
Daytime alertness	Weeks 1, 2, 3, and 4
Ability to concentrate	Weeks 1, 2, 3, and 4
Physical well-being	Weeks 1, 2, 3, and 4
Ability to function	Weeks 1, 2, 3, and 4
Mean subjective number of nocturnal awakenings due to hot flashes	Weeks 1, 2, 3, and 4
Mean number of hot flashes per day	Weeks 1, 2, 3, and 4
Mean number of nocturnal hot flashes per night	Weeks 1, 2, 3, and 4
Mean severity of hot flashes	Weeks 1, 2, 3, and 4
ESS score	Weeks 2 and 4
ISI score	Weeks 2 and 4
GCS score	Weeks 2 and 4
SDS score	Week 4
withdrawal effects will be assessed for the ISI, ESS, MADRS, MenQOL, Greene Climacteric Scale, Sheehan Disability Scale, and Physician Global Assessment.	Week 5