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Eszopiclone in the Treatment of Insomnia and Fibromyalgia

This study is currently recruiting participants.
Verified by University of Medicine and Dentistry New Jersey, June 2008

Sponsors and Collaborators: University of Medicine and Dentistry New Jersey
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

MedlinePlus related topics:   Fibromyalgia   

Drug Information available for:   Eszopiclone   

U.S. FDA Resources

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

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Total sleep time (TST) as recorded in patient diaries [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wake time after sleep onset (WASO) [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Clinician-rated overall severity of fibromyalgia [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Fibromyalgia Impact Questionnaire [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:   95
Study Start Date:   August 2006
Estimated Study Completion Date:   January 2009
Estimated Primary Completion Date:   January 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

Detailed Description:

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

Criteria

Inclusion Criteria:

  1. Male or female, age 18 through 64.
  2. Meets ACR criteria for FMS, as determined by rheumatological examination and a medical history review.
  3. Reports sleep maintenance insomnia (total sleep time of < 6.5 hours or sleep impairment consisting of 3 of 7 nights per week for a month by history) or sleep onset latency insomnia (at least 3 of 7 nights of sleep latency > 30 minutes), as well as clinically significant daytime distress or impairment during the 1 week self assessment prior to baseline.
  4. Has completed 8th grade and is fluent in English.
  5. If a female of child bearing potential, the patient must be non-pregnant and either post-menopausal or using an approved birth control method. Acceptable birth control methods include: history of tubal ligation, having a male partner who is sterile, IUDs, birth control pills or other hormonal birth control methods (e.g., birth control patch, Depo-Provera injections), and double-barrier methods (e.g., condom and foam).
  6. Antidepressant medication will be allowed if the patient has been on a stable dose for at least one month.

Exclusion Criteria:

  1. Evidence of traumatic injury, inflammatory rheumatic disease, or infectious or endocrine-related arthropathy.
  2. Evidence of a primary sleep disorder (e.g., significant sleep disordered breathing (central or obstructive apnea), periodic limb movement disorder, or REM sleep behavior disorder.
  3. Any current, clinically significant medical condition.
  4. Pregnancy.
  5. Meets DSM-IV criteria for bipolar disorder, psychotic disorder, organic brain syndrome, or psychoactive substance abuse or dependence.
  6. Any current psychiatric disorder that would interfere with study participation (investigator judgment).
  7. Active suicidal ideation.
  8. Plans to engage in additional psychotherapy during the study.
  9. Concurrent use of benzodiazepines after 6pm or as a sleep aid.
  10. Concurrent use of any other sleep aid.
  11. Concurrent use of analgesics other than acetaminophen or non-steroidal anti-inflammatory medication.
  12. Concurrent use of any medication that has not been stabilized for at least 1 month prior to screening.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392041

Contacts
Contact: Lesley A. Allen, Ph.D.     732-235-4412     allenla@umdnj.edu    
Contact: Jade Tiu, B.A.     732-235-3378     tiuje@umdnj.edu    

Locations
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.            

Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Sepracor, Inc.

Investigators
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
First Received:   October 24, 2006
Last Updated:   June 9, 2008
ClinicalTrials.gov Identifier:   NCT00392041
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
Fibromyalgia  
Insomnia  
Sleep  
Eszopiclone  
Lunesta  

Study placed in the following topic categories:
Sleep Initiation and Maintenance Disorders
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Mental Disorders
Myofascial Pain Syndromes
Fibromyalgia
Dyssomnias
Sleep Disorders
Pain
Rheumatic Diseases
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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