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

NCT00231673 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2011-06-08

No results posted yet for this study

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.

Conditions

  • Diabetic Neuropathies
  • Diabetes Mellitus, Type 2
  • Polyneuropathies

Interventions

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

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Completion
2003-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00231673 on ClinicalTrials.gov