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

June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Study Completion (Actual)

January 1, 2003

Study Registration Dates

First Submitted

September 30, 2005

First Submitted That Met QC Criteria

September 30, 2005

First Posted (Estimate)

October 4, 2005

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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