Trial Information

Summary: Fibromyalgia research study

Fibromyalgia is a common syndrome characterized by chronic widespread body pain and tenderness.

Participants receive an investigational drug or placebo for 14 weeks. A total of 8 office visits will be scheduled during which participants undergo evaluations including study related physical exam, neurological testing, tender point assessment, laboratory tests, and electrocardiograms.

The primary purpose of this research study is to evaluate the safety, effectiveness and tolerability of an investigational drug, administered once daily, compared with placebo (a pill does not contain any drug) in alleviating the pain and fatigue associated with fibromyalgia.

If eligible, you will receive study-related procedures at no cost. Compensation for travel is also provided. All information provided to us will be kept confidential.

Patient Inclusion Criteria:

• Are at least 18 years old
• Have confirmed symptoms of fibromyalgia based on physical exam and tender point assessment
• Have widespread body pain that has lasted for at least 3 months
• Are in generally stable health
• Meet all other study requirements

Specific exclusion criteria will be evaluated during the initial patient phone screening.