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Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia | Clinical Trials | Clareo Health

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

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.

NCT00313885•Sanofi

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

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

Locations (12)

Radiant Research

Phoenix, Arizona, United States

San Diego Arthritis Medical Clinic

San Diego, California, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Miami Research Assoc., Inc.

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Comprehensive Neuroscience

Atlanta, Georgia, United States

Physicians Research Group

Indianapolis, Indiana, United States

Wichita Clinic PA

Wichita, Kansas, United States

Westroads Medical Group

Omaha, Nebraska, United States

Physicians Research Options

Ogden, Utah, United States

Key Dates

Start Date

April 1, 2004

Primary Completion Date

June 1, 2005

Completion Date

June 1, 2005

Last Updated

November 30, 2010

Enrollment

205

ACTUAL participants

Conditions

FibromyalgiaSleepChronic Pain

Interventions

eplivanserin (SR46349)

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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