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

Phase 2

Completed

• Conditions: Fibromyalgia; Sleep; Chronic Pain
• Interventions: Drug: eplivanserin (SR46349); Drug: placebo

• Registration Number: NCT00313885
• Lead Sponsor: Sanofi

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2006-04-07
• Study First Submitted QC: 2006-04-07
• Study First Posted: 2006-04-12
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-29
• Last Update Posted: 2010-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	eplivanserin (SR46349)	1 mg daily
2	eplivanserin (SR46349)	5 mg daily
3	placebo	-

Primary Outcome Measures

Name	Time	Method
refreshing quality of sleep measured by the patient sleep questionnaire	8 weeks

Secondary Outcome Measures

Name	Time	Method
sleep parameters (maintenance, duration, induction and quality)	8 weeks

Trial Locations

Locations (12)

Wichita Clinic PA; 🇺🇸 Wichita, Kansas, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

Comprehensive Neuroscience; 🇺🇸 Atlanta, Georgia, United States

San Diego Arthritis Medical Clinic; 🇺🇸 San Diego, California, United States

Miami Research Assoc., Inc.; 🇺🇸 Miami, Florida, United States

Physicians Research Group; 🇺🇸 Indianapolis, Indiana, United States

Westroads Medical Group; 🇺🇸 Omaha, Nebraska, United States

Physicians Research Options; 🇺🇸 Ogden, Utah, United States

Seattle Rheumatology Assoc.; 🇺🇸 Seattle, Washington, United States

Sanofi-Aventis Administrative Office; 🇨🇦 Laval, Canada

Radiant Research; 🇺🇸 Phoenix, Arizona, United States