Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia

Study Overview
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Brief Summary
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Fibromyalgics frequently report sleep disturbances, in particular poor and unrefreshing sleep. Additionally, studies have reported that sleep problems, pain and mood disturbances are associated in patients with fibromyalgia. By improving the quality of sleep, complaints of poor and unrefreshing sleep, fatigue, pain, which are among the main components of this chronic pain disorder may be improved.

Detailed Description
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The purpose of this research study is to investigate the effectiveness and safety of 2 doses of the investigational product in subjects with sleep disorders with fibromyalgia as compared to placebo (a substance which contains no active ingredient). The study will last approximately 70 days and will include 7 office visits.

Official Title
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Efficacy and Safety of SR46349B (1 and 5mg/Day) Administered During 8 Weeks in Patients With Sleep Disorders in Fibromyalgia: Multi-center, Randomized, Double-blind, Placebo-controlled Study.

Conditions
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Fibromyalgia, Sleep, Chronic Pain

Intervention / Treatment
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* Drug: eplivanserin (SR46349)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Each patient must fulfill the diagnosis criteria of fibromyalgia according to the American College of Rheumatology Based on patient's information: The patient must complain of unrefreshing sleep for at least 3 nights per week over the past month. The patient spends at least 6.5 hours and not more than 9 hours, in bed, each night over the past 2 weeks. Female patients of childbearing potential must have a confirmed negative pregnancy test at the end of the screening period and use an acceptable method of birth control throughout the study Written, signed and dated informed consent must be obtained from each patient Willing to abstain from taking any medication or treatment prohibited as per the protocol Exclusion Criteria: Females who are lactating or pregnant Night shift workers, and individuals who nap 3 or more times per week over the preceding month (nap: intentionally sleeping for more than 20 minutes during the day). Consumption of beverage with caffeine (i.e. tea, coffee, or cola) comprising more than 2 cups or glasses per day Past or Current medical history of any significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1 mg daily | Drug: eplivanserin (SR46349)<br>* oral administration<br>|
| Experimental: 2<br>5 mg daily | Drug: eplivanserin (SR46349)<br>* oral administration<br>|
| Placebo Comparator: 3<br> | Drug: placebo<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| refreshing quality of sleep measured by the patient sleep questionnaire |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep parameters (maintenance, duration, induction and quality) |  | 8 weeks |