The TopCSPN study is a multicenter, randomized, parallel-group, double-blind, placebo-controlled, Phase II clinical trial. The purpose of this study is to determine if a target daily dose of 100 milligrams of oral topiramate slows the progression of neuropathy and improves quality of life for adults age 18-80 with cryptogenic sensory peripheral neuropathy (commonly called idiopathic neuropathy), who also have symptoms of metabolic disease (such as high cholesterol, elevated blood sugar, high blood pressure, and abdominal obesity) at screening.
A variety of assessments and questionnaires will be performed during study visits to evaluate if topiramate improves neuropathy symptoms. These study visits will be conducted over a 96-week (24-month) treatment period, with in-person visits occurring every 16 weeks and monthly follow-up phone calls in between visits.
Principal Investigator: Erik Ortega, MD