Fibromyalgia, Insomnia
Conditions
Keywords
Fibromyalgia, Insomnia, Sleep, Eszopiclone, Lunesta
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.
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.
Interventions
DRUGEszopiclone
3mg qpm for 12 weeks
DRUGplacebo
1 pill qpm for 12 weeks
Sponsors
Sumitomo Pharma America, Inc.
Lesley A. Allen, Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Sleep Time (TST) as Recorded in Patient Diaries | week 4 | Difference in total sleep time between week 4 and baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wake Time After Sleep Onset (WASO) | week 12 | Minutes awake after sleep onset as recorded in patient diaries |
| Sleep Quality | week 12 | — |
| Clinician-rated Overall Severity of Fibromyalgia | week 12 | — |
| Fibromyalgia Impact Questionnaire | week 12 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eszopiclone Eszopiclone: 3mg qpm for 12 weeks | 19 |
| Placebo placebo: 1 pill qpm for 12 weeks | 17 |
| Total | 36 |
Baseline characteristics
| Characteristic | Eszopiclone | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 41.58 years STANDARD_DEVIATION 8.6 | 44.11 years STANDARD_DEVIATION 10.11 | 46.94 years STANDARD_DEVIATION 11.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 29 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 29 Participants | 14 Participants |
| Region of Enrollment United States | 19 participants | 36 participants | 17 participants |
| Sex: Female, Male Female | 19 Participants | 36 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 17 |
| serious Total, serious adverse events | 0 / 19 | 0 / 17 |
Outcome results
Primary
Change in Total Sleep Time (TST) as Recorded in Patient Diaries
Difference in total sleep time between week 4 and baseline
Time frame: week 4
Population: Data are reported through week 4, instead of through week 12 as planned, because of the high drop out rate after week 4. Fewer than 50% of participants remained in the study at week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eszopiclone | Change in Total Sleep Time (TST) as Recorded in Patient Diaries | 68.72 minutes | Standard Deviation 69.72 |
| Placebo | Change in Total Sleep Time (TST) as Recorded in Patient Diaries | 13.47 minutes | Standard Deviation 83.21 |
Secondary
Clinician-rated Overall Severity of Fibromyalgia
Time frame: week 12
Population: Data recorded was of too poor quality to analyze in a meaningful way
Secondary
Fibromyalgia Impact Questionnaire
Time frame: week 12
Population: Data recorded was of too poor quality to analyze in a meaningful way
Secondary
Sleep Quality
Time frame: week 12
Population: Data recorded was of too poor quality to analyze in a meaningful way
Secondary
Wake Time After Sleep Onset (WASO)
Minutes awake after sleep onset as recorded in patient diaries
Time frame: week 12
Population: Data collected was of too poor quality to analyze in a meaningful way