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Fabry Disease | Safety and Efficacy of Gabapentin for Neuropathic Pain in Fabry Disease

Fabry Disease research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Fabry Disease

Neuropathic Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Gabapentingabapentin 100 mg capsules

Drug:placebocompounded placebo capsules

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

gabapentin

placebo

Study Status

Withdrawn

Start Date: April 2012

Completed Date: June 2014

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: average reduction in hydrocodone-acetaminophen use

Secondary Outcome: Number and type of adverse events

Study sponsors, principal investigator, and references

Principal Investigator: Jeanine R. Jarnes, PharmD

Lead Sponsor: University of Minnesota - Clinical and Translational Science Institute

Collaborator: Genzyme, a Sanofi Company

More information:https://clinicaltrials.gov/show/NCT01588314

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