NeuroNEXT and the National Institute of Neurological Disorders and Stroke (NINDS) are undergoing a double-blind, placebo clinical trial looking at the effectiveness of treating peripheral neuropathy with the FDA-approved drug, topiramate. This is a 96-week placebo-controlled trial of topiramate at a target dose of 100 mg daily (50 mg twice daily) as a potentially disease altering therapy for Cryptogenic Sensory Peripheral Neuropathy (CSPN).
What is Cryptogenic Sensory Peripheral Neuropathy?
A common cause of neuropathy is diabetes, but in about 25 to 50% of the population, no cause is found. This group is often referred to as Cryptogenic Sensory Peripheral Neuropathy. Symptoms of CSPN typically progress slowly. On examination, there may be additional mild toe flexion and extension weakness. Electrophysiologic testing and histology reveals axonal neuropathy. Prognosis is usually favorable, as most patients maintain independent ambulation. Besides patient education and reassurance, management is focused on pharmacotherapy for neuropathic pain and physical therapy for balance training, and, occasionally, assistive devices.
Trial Eligibility Criteria
To participate in this trial please contact a coordinator near you, some requirements are:
- Age 18-75
- Diagnosis of confirmed cryptogenic symptomatic distal symmetric peripheral polyneuropathy
- Prediabetes based on American Diabetes Association criteria
- No history of prior therapy with topiramate
- Waist circumference >102 cm for men, >88 cm for women
For more information about this trial, please contact a coordinator below or go to ClinicalTrials.gov
- Identifier NCT02878798
- IRB number STU00206049
Albert Einstein College of Medicine – Bronx, NY
Columbia University Medical Center – New York, NY
Eastern Virginia Medical Center – Norfolk, VA
Massachusetts General Hospital – Boston, MA
Northwestern University – Chicago, IL
Ohio State University Wexner Medical Center – Columbus, OH
University of Alabama at Birmingham – Birmingham, AL
University of Colorado – Denver – Aurora, CO
University of Kansas Medical Center – Kansas City, KS
University of Miami School of Medicine – Miami, FL
University of Rochester – Rochester, NY
University of Texas Southwestern Medical Center – Dallas, TX
University of Utah – Salt Lake City, UT
Vanderbilt University – Nashville, TN
Washington University in St. Louis School of Medicine – St. Louis, MO
To find out more about other clinical trials being offered to peripheral neuropathy patients, please go to the Foundation for Peripheral Neuropathy’s Clinical Trials website.