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DN41 - VX16-150-102 for Small Fiber Neuropathy Pain - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about the safety and side effects of VX-150, a study drug, intended to treat neuropathic pain.

What is the Condition Being Studied?

Small fiber neuropathy

Who Can Participate in the Study?

Adults age 18-80 with small fiber neuropathy who have had neuropathic pain for at least 3 months

Age Group
Adults

What is Involved?

If you choose to be in the study, you will  
- Have 7 outpatient visits (over a 15 week period), which will last about 2-4 hours each.  
- Be asked to stop your current pain medications for 7 weeks.
- Be randomized (like flipping a coin) to receive either the
--- Study drug (VX-150) or
--- A placebo (sugar pill).  
- Have a punch biopsy to confirm your diagnosis of small fiber neuropathy  
- Have blood and urine samples, ECGs, and vital signs collected several visits.  
- Have physical and neurological exams performed throughout the study.  
- Be asked to rate your pain and sleep daily via an electronic diary and complete questionnaires regarding your health. 

Study Details

Full Title
A Phase 2, Randomized, Double-blind, Placebo controlled, 6-Week, Parallel-design Study of the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber Neuropathy;VX16-150-102
Principal Investigator
Protocol Number
IRB:PRO00087982
NCT:NCT03304522
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698