Trial Information

Summary: Painful Diabetic Peripheral Neuropathy

We are conducting a clinical research study for volunteers diagnosed with Diabetes (Type 1 or 2) experiencing painful neuropathy for at least 6 months. This study tests the safety and effectiveness of 2 different does of an investigational drug compared to placebo.

Study Criteria:

• Age 18+
• Diagnosed with Type 1 or 2 Diabetes
• Presence of pain due to Diabetic peripheral neuropathy for at least 6 months
• Hemoglobin A1C of = 11%
• The primary pain location must be in the feet
• No presence of other painful conditions that could affect the assessment of the pain due to DPN such as peripheral vascular disease, amputations (other than toe), arthritis, fibromyalgia, thoracic radiculopathy or lumbar radiculopathy
• History of lack of response to Cymbalta, Effexor XR, or tricyclic antidepressants (TCAs)
• No history of significant psychiatric or other neurological disorders
• No history of any seizures disorder or epilepsy (within the last 10 years)
• No history of brain injury, stroke, TIA, or brain neoplasm within 1 year
• No current ecidence of fastrointestinal, hematopoietic, renal, respiratory, or cardiovascular systems: urinary retention; or glaucoma
• No drug or alcohol abuse within 2 years
• A mass body index (BMI) of = 40
• No previous clinical study with bicifadine
• No investigational drug within 30 days
• No pregnant or lactating women

If eligible, you will receive investigational drug and study-related medical care at no cost. Reimbursement for time and travel may also be available.

For additional information about this study or to enroll, visit our website:
www.clinicaltrialsinc.com

If you would like to learn more about participating in this study, please send an e-mail message using the form below.