A study of the drug topiramate as a disease modifying therapy for cryptogenic sensory peripheral neuropathy in metabolic syndrome (TopCSPN)

What we are studying

This study will determine if an FDA-approved drug called Topiramate can slow the progression of mild diabetic, pre-diabetic, or metabolic syndrome associated peripheral neuropathy (nerve damage that interferes with the functioning of the nervous system, particularly in the hands/arms and feet/legs).

Who is Eligible

  • All Genders
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18 - 80

Eligibility Criteria

  • Those with peripheral neuropathy due to unknown cause
  • Pre-Diabetes
  • Mild diabetes (HGbA1c < 7.6)
  • Common exclusions are:
  • Previous use of topiramate
  • A history of recurrent kidney stones or epilepsy
  • Diabetic foot ulcers
  • Major malignancies
  • Use of opiates more than 3 times per week.

What is involved

  • Informed Consent Review
  • Review of Medical History
  • Physical Examinations
  • Study Visits and Consultations
  • Surveys/Questionnaires
  • Laboratory and Imaging Tests
  • Specimen Sample Collection
  • Use of Study Treatments or Placebo
  • Use of Study Health Plans
  • After Study Follow-Up Activities

Compensation

Compensation will be discussed with each potential participant.

Contact Information

Study Coordinator
Summer Harris
Email
sdharris@wakehealth.edu
Phone
(336) 716-3919
Principal Investigator
James B. Caress, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.