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Using An Investigational Drug to Treat Non-Diabetic Nerve Pain ("TopCSPN")

Research Question:
Can the medication topiramate(Topamax®) taken by mouth daily for 96 weeks slow the progression of non-diabetic nerve pain and improve your quality of life compared to taking a placebo?

Basic Study Information

Purpose:
Many people experience nerve pain and tingling in their hands and feet that has a known cause, such as diabetes. When there is no identifiable medical reason for the nerve pain (‘neuropathy’) you are experiencing, it is called Cryptogenic Sensory Peripheral Neuropathy, “CSPN,” for short. This study is a double blind, randomized placebo-controlled trial of topiramate at a target dose of 100 mg daily for 96 weeks as a potential therapy for the nerve pain of CSPN. Topiramate is the Investigational Drug in this study. Topiramate is approved by the US Food and Drug Administration for prevention of migraines and seizures, but not for the treatment of nerve pain. Study participants will be randomized 1:1 to topiramate or placebo (sugar pill). Neither participants nor the Study Team will know which group participants are in. All participants will return to the clinic for follow up visits once every 16 weeks for evaluation. Evaluations will include assessments and questionnaires to determine if topiramate improves symptoms of CSPN and makes your life better.

Location: UR, Clinical Research Center
Study Web URL:  https://neuronext.org/clinical-sites/university-rochester https://neuronext.org/clinical-sites/university-rochester
Study Reference #: 00069677

Lead Researcher (Principal Investigator)

Lead Researcher: Peter Creigh

Study Contact Information

Study Coordinator: Janet Sowden
Phone: (585) 275-1267
Email: janet_sowden@urmc.rochester.edu

Additional Study Details

Study Details:
You may be eligible for this study if you are 18-80 years old, have a diagnosis of nerve pain without a specific known cause, have NOT been told you have diabetes, but you DO have high blood pressure, high cholesterol and/or lipid (fat) levels and have never taken the medication topiramate (Topamax®). The study will include blood draws, skin biopsies, and multiple quality of life questionnaires to look at nerve fiber density (a measure of nerve health in the skin), and randomization to either topiramate or placebo (sugar pill) for 96 weeks. There will be 8 visits over 96 weeks: a Screening visit, a Baseline Visit and 6 Study Visits every 16 weeks: Weeks 16, 32, 48, 64, 80 and 96. You will also be asked to return for a Safety Assessment Visit about 4 weeks following your last dose of study drug. It will take about two years to complete all the visits in this study.

Number of Visits:  6 to 10
Parking:  Free
Transportation Coverage: 
Reimbursement:  Yes
Payment Details:  Participants will be reimbursed $50 for the screening visit and $100 for every clinic follow-up visit after that (Baseline, Weeks 16, 32, 48, 64, 80 and 96). The maximum amount for taking part in this study is $750.

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