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6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia

Primary Insomnia Clinical Trial

Official title:
A Six-Month, Chronic Efficacy and Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia: A Randomized Double-Blind, Placebo-Controlled Study

Clinical Trial Summary

To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures, compared to placebo.

Clinical Trial Description

This is a double blind, randomized (2:1; eszopiclone : placebo), placebo-controlled, multicenter, study of eszopiclone in subjects with primary insomnia. The study will involve up to 9 visits and subject participation will be approximately 224 days. After meeting all screening criteria, subjects will be randomized to either eszopiclone 3 mg QD or placebo. 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00352144
Study type Interventional
Source Sunovion
Contact
Status Completed
Phase Phase 3
Start date October 2003
Completion date October 2004
View Details
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