Eszopiclone in the Treatment of Insomnia and Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00392041
First received: October 24, 2006
Last updated: February 19, 2014
Last verified: February 2014
  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 4

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: Eszopiclone in the Treatment of Insomnia and Associated Symptoms of Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of 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 ]

Enrollment: 36
Study Start Date: August 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eszopiclone Drug: Eszopiclone
3mg qpm for 12 weeks
Other Name: Lunesta
Placebo Comparator: Placebo 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Sunovion
Investigators
Principal Investigator: Lesley A. Allen, Ph.D. Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00392041     History of Changes
Other Study ID Numbers: 0220060122
Study First Received: October 24, 2006
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Fibromyalgia
Insomnia
Sleep
Eszopiclone
Lunesta

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Sleep Initiation and Maintenance Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Mental Disorders
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014