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

Launched by JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, L.L.C. · Sep 30, 2005

Keywords

ClinConnect Summary

This is a multicenter, double-blind, placebo-controlled study to evaluate the effect of topiramate on clinical and electrophysiological parameters in patients with diabetic peripheral polyneuropathy. Patients will undergo the Baseline Phase when they are tapered off other pain medications, have diabetes controlled and eligibility reassessed. Patients will then be randomized to receive either topiramate or placebo and enter the Double-Blind Phase, which consists of Titration Period (topiramate dose will be titrated from 25mg/day to 200mg/day over 42 days) and Maintenance Period (study medica...

Gender

ALL

Eligibility 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