Eszopiclone in the Treatment of Insomnia and Fibromyalgia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00392041
• Date of registration: 24/10/2006
• Prospective Registration: No
• Primary sponsor: University of Medicine and Dentistry of New Jersey
• Public title: Eszopiclone in the Treatment of Insomnia and Fibromyalgia
• Scientific title: Eszopiclone in the Treatment of Insomnia and Associated Symptoms of Fibromyalgia
• Date of first enrolment: August 2006
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00392041
• 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
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Lesley A. Allen, Ph.D.
• Affiliation: Rutgers, The State University of New Jersey

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Fibromyalgia

Insomnia

Intervention(s)

Drug: placebo

Drug: Eszopiclone

Primary Outcome(s)

Total sleep time (TST) as recorded in patient diaries [Time Frame: week 12]

Secondary Outcome(s)

Clinician-rated overall severity of fibromyalgia [Time Frame: week 12]

Fibromyalgia Impact Questionnaire [Time Frame: week 12]

Sleep quality [Time Frame: week 12]

Wake time after sleep onset (WASO) [Time Frame: week 12]

Secondary ID(s)

0220060122

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sunovion