Eszopiclone in the Treatment of Insomnia and Fibromyalgia

NCT00392041 | Completed Phase 4 Results

• 1 other identifier: 0220060122
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Insomnia

Keywords

Fibromyalgia; Insomnia; Sleep; Eszopiclone; Lunesta

Outcome Measures

Primary Outcomes (1)

• Change in Total Sleep Time (TST) as Recorded in Patient Diaries

  Difference in total sleep time between week 4 and baseline

  week 4

Secondary Outcomes (4)

• Wake Time After Sleep Onset (WASO)

  week 12

• Sleep Quality

  week 12

• Clinician-rated Overall Severity of Fibromyalgia

  week 12

• Fibromyalgia Impact Questionnaire

  week 12

Study Arms (2)

Eszopiclone

EXPERIMENTAL

Drug: Eszopiclone

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Eszopiclone DRUG

3mg qpm for 12 weeks

Also known as: Lunesta

Eszopiclone

placebo DRUG

1 pill qpm for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, age 18 through 64.
• Meets ACR criteria for FMS, as determined by rheumatological examination and a medical history review.
• 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.
• Has completed 8th grade and is fluent in English.
• 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).
• Antidepressant medication will be allowed if the patient has been on a stable dose for at least one month.

You may not qualify if:

• Evidence of traumatic injury, inflammatory rheumatic disease, or infectious or endocrine-related arthropathy.
• 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.
• Any current, clinically significant medical condition.
• Pregnancy.
• Meets DSM-IV criteria for bipolar disorder, psychotic disorder, organic brain syndrome, or psychoactive substance abuse or dependence.
• Any current psychiatric disorder that would interfere with study participation (investigator judgment).
• Active suicidal ideation.
• Plans to engage in additional psychotherapy during the study.
• Concurrent use of benzodiazepines after 6pm or as a sleep aid.
• Concurrent use of any other sleep aid.
• Concurrent use of analgesics other than acetaminophen or non-steroidal anti-inflammatory medication.
• Concurrent use of any medication that has not been stabilized for at least 1 month prior to screening.

Sponsors & Collaborators

• Lesley A. Allen, Ph.D.: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Sleep Initiation and Maintenance Disorders

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Results Point of Contact

• Title: Lesley Allen, Ph.D.
• Organization: Princeton University

lesleyaallen@gmail.com

609-924-9213

Study Officials

• Lesley A. Allen, Ph.D.

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: October 24, 2006
• First Posted: October 25, 2006
• Study Start: August 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)