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| Sponsor: | University of Medicine and Dentistry New Jersey |
|---|---|
| Collaborator: |
Sepracor, Inc. |
| Information provided by: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00392041 |
Purpose
The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia. It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time, sleep quality, pain, fatigue, physical functioning, and emotional distress than will those receiving placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia Insomnia |
Drug: Eszopiclone Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Eszopiclone in the Treatment of Insomnia and Associated Symptoms of Fibromyalgia |
| Estimated Enrollment: | 95 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Eszopiclone
3mg qpm for 12 weeks
|
| 2: Placebo Comparator |
Drug: placebo
1 pill qpm for 12 weeks
|
Fibromyalgia (FM) is a prevalent, debilitating, and costly syndrome. Although the pathophysiology of FM is not yet well-understood, sleep disturbance is a prominent feature of most theories. Eszopiclone has been approved by the FDA for the treatment of insomnia, but has not been studied in the treatment of FMS. The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia (FMS) in FMS patients. Participants will be randomly selected to receive eszopiclone or placebo. It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time, sleep quality, pain, fatigue, physical functioning, and emotional distress than will those receiving placebo.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lesley A. Allen, Ph.D. | 732-235-4412 | allenla@umdnj.edu |
| Contact: Jade Tiu, B.A. | 732-235-3378 | tiuje@umdnj.edu |
| United States, New Jersey | |
| Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School | Recruiting |
| Piscataway, New Jersey, United States, 08854 | |
| Contact: Jade Tiu, B.A. 732-235-3378 tiuje@umdnj.edu | |
| Principal Investigator: Lesley A. Allen, Ph.D. | |
| Sub-Investigator: Matthew Menza, M.D. | |
| Principal Investigator: | Lesley A. Allen, Ph.D. | University of Medicine and Dentistry New Jersey |
More Information
| Responsible Party: | UMDNJ-Robert Wood Johnson Medical School ( Lesley A. Allen, Ph.D./Principal Investigator ) |
| Study ID Numbers: | 0220060122 |
| Study First Received: | October 24, 2006 |
| Last Updated: | March 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00392041 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Fibromyalgia Insomnia Sleep Eszopiclone Lunesta |
|
Sleep Initiation and Maintenance Disorders Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Mental Disorders Myofascial Pain Syndromes |
Fibromyalgia Nervous System Diseases Sleep Disorders Dyssomnias Rheumatic Diseases Sleep Disorders, Intrinsic |