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:Location: UR, Clinical Research Center
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.
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 InformationStudy Coordinator: Janet Sowden
Phone: (585) 275-1267
Additional 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
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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