Safety and Efficacy of Gabapentin for Neuropathic Pain in Fabry Disease

• Status: Withdrawn
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine efficacy of gabapentin vs. placebo at controlling peripheral neuropathic pain in patients with Fabry disease, and reducing their use of opioid analgesics. The investigators are conducting a randomized, double-blind, placebo controlled, single center, cross-over study. The primary endpoint is percent reduction in patients' use of hydrocodone-acetaminophen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

Inclusion Criteria:

• diagnosis of Fabry Disease

• age ≥ 18 years of age at study enrollment

• current neuropathic pain at any severity level

Exclusion Criteria:

• known sensitivity or allergy to study drug

• history of illicit drug use

• pregnancy

• suicidal thoughts at study enrollment as assess by the C-SSRS