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| Sponsor: | Sunovion |
|---|---|
| Information provided by: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT00352144 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Insomnia |
Drug: Eszopiclone Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 830 |
| Study Start Date: | October 2003 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
eszopiclone 3 mg tablet
|
Drug: Eszopiclone
Eszopiclone 3 mg
Other Names:
|
|
Placebo Comparator: 2
Placebo tablet
|
Drug: Placebo
Placebo tablet
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
Show 58 Study Locations
More Information
| Responsible Party: | Eszopiclone Medical Director, Sunovion Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00352144 History of Changes |
| Other Study ID Numbers: | 190-050 |
| Study First Received: | July 12, 2006 |
| Last Updated: | November 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Mental Disorders Eszopiclone |
Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |