Clinical Trial 2869

New York, NY 10022

Study Summary:

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

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.

Qualified Participants Must:

• Be at least 18 years of age
• 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
• Be in generally stable health
• Meet all other study requirements

Qualified Participants May 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.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.