An Efficacy and Safety Study of Carisbamate in the Treatment of Nerve Pain in Diabetics

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of carisbamate (800 and 1200 mg/day) in patients with diabetic neuropathic pain.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Life Science; SK Life Science, Inc.
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Patients with diabetes mellitus (type 1 or 2)

• Have had diabetes-related painful peripheral neuropathy in the lower extremities for >=6 months prior to entry

• Have experienced lower extremity pain on a nearly daily basis for the previous 3 months

• Have a mean daily average DPN pain score of >=4 (on an 11-point scale) during the baseline period

• Have had a stable diabetic treatment regimen, including oral hypoglycemics, insulin, or diet, for >=3 months before screening

• Have hemoglobin A1c levels <=11%

• Willing to discontinue prohibited medications, including antiepileptic drugs (including gabapentin and pregabalin), opioids or opioid-containing pain medications, and antidepressants

• Women must be postmenopausal for >=2 years, surgically sterile, abstinent, or practicing a highly effective method of birth control

• Women of childbearing potential must have a negative pregnancy test at screening and on Day 1.

Exclusion Criteria:

• History of poor response to >=3 classes of medications for DPN

• Currently taking warfarin (Coumadin)

• Prior treatment with neurolysis (destruction of nerves by application of chemicals, heat, or cold), neurosurgery, intrathecal pumps, or spinal cord stimulators for DPN

• Use of herbal topical creams or ointments for pain relief with 48 hours, capsaicin with 6 months, or systemic (oral) corticosteroids with 3 months before the baseline period

• Any dermatologic or vascular disease in the limbs affected by the neuralgia that may interfere with assessment, including a diabetic ulcer or to or limb amputation

• Hospitalized within the last month for episodes of hypoglycemia or hyperglycemia

• History of progressive or neurologic disorders (such as multiple sclerosis, amyotrophic lateral sclerosis)