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| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eszopiclone | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eszopiclone | Drug | 3mg qpm for 12 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Sleep Time (TST) as Recorded in Patient Diaries | Difference in total sleep time between week 4 and baseline | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Wake Time After Sleep Onset (WASO) | Minutes awake after sleep onset as recorded in patient diaries | week 12 |
| Sleep Quality | week 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lesley A. Allen, Ph.D. | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School | Piscataway | New Jersey | 08854 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eszopiclone | Eszopiclone: 3mg qpm for 12 weeks |
| FG001 | Placebo | placebo: 1 pill qpm for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First 4 Weeks |
| |||||||||||||
| Weeks 5 - 12 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eszopiclone | Eszopiclone: 3mg qpm for 12 weeks |
| BG001 | Placebo | placebo: 1 pill qpm for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Total Sleep Time (TST) as Recorded in Patient Diaries | Difference in total sleep time between week 4 and baseline | 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. | Posted | Mean | Standard Deviation | minutes | week 4 |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eszopiclone | Eszopiclone: 3mg qpm for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lesley Allen, Ph.D. | Princeton University | 609-924-9213 | lesleyaallen@gmail.com |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| placebo | Drug | 1 pill qpm for 12 weeks |
|
| Clinician-rated Overall Severity of Fibromyalgia |
| week 12 |
| Fibromyalgia Impact Questionnaire | week 12 |
| NOT COMPLETED |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Wake Time After Sleep Onset (WASO) | Minutes awake after sleep onset as recorded in patient diaries | Data collected was of too poor quality to analyze in a meaningful way | Posted | week 12 |
|
|
| Secondary | Sleep Quality | Data recorded was of too poor quality to analyze in a meaningful way | Posted | week 12 |
|
|
| Secondary | Clinician-rated Overall Severity of Fibromyalgia | Data recorded was of too poor quality to analyze in a meaningful way | Posted | week 12 |
|
|
| Secondary | Fibromyalgia Impact Questionnaire | Data recorded was of too poor quality to analyze in a meaningful way | Posted | week 12 |
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Placebo | placebo: 1 pill qpm for 12 weeks | 0 | 17 | 0 | 17 |
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| D009422 |
| Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
| D011725 |
| Pyridines |