drugset / Trial / NCT02607254

Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy

NCT02607254

Phase 2 Completed 11 enrolled Johns Hopkins University Pfizer · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to assess safety and efficacy of treatment with pregabalin in patients with idiopathic small fiber neuropathy proven by skin biopsy.This is an enriched enrollment randomized withdrawal study that comprises 4 phases: a screening and selection phase, a washout period from previous pain medication for enriched enrollment, an 8 week single blind pregabalin treatment phase; and a 4 week randomized withdrawal phase.

Timeline

Start
2015-09
Primary completion
2018-07
Completion
2018-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregabalin Small molecule 225 mg