Eszopiclone in the Treatment of Insomnia and Fibromyalgia

• ClinicalTrials.gov Identifier: NCT00392041
• Recruitment Status: Completed
• First Posted: October 25, 2006
• Results First Posted: January 5, 2021
• Last Update Posted: January 5, 2021
• Sponsor: Lesley A. Allen, Ph.D.
• Collaborator: Sunovion
• Information provided by (Responsible Party): Lesley A. Allen, Ph.D., University of Medicine and Dentistry of New Jersey

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Fibromyalgia; Insomnia	Drug: Eszopiclone; Drug: placebo	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Eszopiclone in the Treatment of Insomnia and Associated Symptoms of Fibromyalgia
• Study Start Date: August 2006
• Actual Primary Completion Date: March 2009
• Actual Study Completion Date: March 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Eszopiclone	Drug: Eszopiclone; 3mg qpm for 12 weeks; Other Name: Lunesta
Placebo Comparator: Placebo	Drug: placebo; 1 pill qpm for 12 weeks

Outcome Measures

Primary Outcome Measures :

1. Change in Total Sleep Time (TST) as Recorded in Patient Diaries [ Time Frame: week 4 ]
   Difference in total sleep time between week 4 and baseline

Secondary Outcome Measures :

1. Wake Time After Sleep Onset (WASO) [ Time Frame: week 12 ]
   Minutes awake after sleep onset as recorded in patient diaries
2. Sleep Quality [ Time Frame: week 12 ]
3. Clinician-rated Overall Severity of Fibromyalgia [ Time Frame: week 12 ]
4. Fibromyalgia Impact Questionnaire [ Time Frame: week 12 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, New Jersey

Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School

Piscataway, New Jersey, United States, 08854

Sponsors and Collaborators

Lesley A. Allen, Ph.D.

Sunovion

Investigators

• Principal Investigator: Lesley A. Allen, Ph.D.; Rutgers, The State University of New Jersey

More Information

• Responsible Party: Lesley A. Allen, Ph.D., Associate Professor of Psychiatry, University of Medicine and Dentistry of New Jersey
• ClinicalTrials.gov Identifier: NCT00392041
• Other Study ID Numbers: 0220060122
• First Posted: October 25, 2006
• Results First Posted: January 5, 2021
• Last Update Posted: January 5, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Lesley A. Allen, Ph.D., University of Medicine and Dentistry of New Jersey:

Fibromyalgia; Insomnia; Sleep; Eszopiclone; Lunesta

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Eszopiclone; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs