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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Fibromyalgia; Chronic Pain; Sleep

Treatments: Drug: placebo; Drug: eplivanserin (SR46349)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00313885

ACT5400

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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205 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

1 mg daily

Treatment:

Drug: eplivanserin (SR46349)

2

Experimental group

Description:

5 mg daily

Treatment:

Drug: eplivanserin (SR46349)

3

Placebo Comparator group

Treatment:

Drug: placebo