A Study To Evaluate The Effect Of Topiramate On Clinical And Electrophysiological Parameters In Subjects With Diabetic Peripheral Polyneuropathy

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the effect of topiramate on clinical and electrophysiological parameters in patients with diabetic peripheral polyneuropathy. The study will also evaluate the safety of topiramate in this patient population.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Diagnosis of type 2 diabetes mellitus

• Pain for at least 6 months prior to randomization that the investigator attributes to diabetic peripheral polyneuropathy

• Two sets of baseline nerve conduction studies and Quantitative Sensory Testing

• HbA1c =< 9%

• Diabetes controlled on stable regimen

• Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

• Diagnosis of Type 1 diabetes mellitus

• Polyneuropathy due to other underlying causes

• Hospitalization within the past 3 months due to episodes of hyper/hypoglycemia

• Other unstable medical conditions

• History of suicidal attempts

• Exposure to any other experimental drugs or device within the past 30 days