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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00231673

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Neuropathies Diabetes Mellitus, Type 2 Polyneuropathies	Drug: Topiramate	Phase 2

Detailed Description

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 medication will be continued for 12 weeks). After the Double-Blind Phase, study medication will be tapered off during the Taper Phase, whose duration will vary depending on each patient. The evaluations include electrophysiological assessment, quantitative sensory assessment, and clinical assessment such as subjective pain scales. Safety evaluations (vital signs, clinical laboratory evaluations, physical and neurological examination, and evaluations of adverse events) will be conducted during the trial. During the first 42 days, doses of topiramate gradually increase to achieve the target dose (200mg daily by mouth), and then the dose is maintained for 12 weeks, after which the dose is slowly reduced and stopped over 12 weeks.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Topiramate on Electrophysiological Parameters in Subjects With Diabetic Peripheral Polyneuropathy

Study Start Date :

Jul 1, 2001

Actual Study Completion Date :

Jan 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 001 Topiramate Increasing dosing of topiramate gradually to 200 mg daily by mouth dose maintenance for 12 weeks then decreasing dose until stopped over 12 weeks	Drug: Topiramate Increasing dosing of topiramate gradually to 200 mg daily by mouth, dose maintenance for 12 weeks, then decreasing dose until stopped over 12 weeks

Arm

Intervention/Treatment

Experimental: 001

Topiramate Increasing dosing of topiramate gradually to 200 mg daily by mouth dose maintenance for 12 weeks then decreasing dose until stopped over 12 weeks

Drug: Topiramate

Increasing dosing of topiramate gradually to 200 mg daily by mouth, dose maintenance for 12 weeks, then decreasing dose until stopped over 12 weeks

Outcome Measures

Primary Outcome Measures

Change in peroneal nerve conduction velocity (NCV) from baseline to the end of the double-blind phase. []

Secondary Outcome Measures

Changes from baseline to the end of the double-blind phase in NCVs of the sural sensory nerve and ulnar (motor and sensory) nerve, and changes in amplitudes and latencies of the peroneal motor, sural sensory, and ulnar nerves. Adverse event reporting. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.