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?
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
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.
Start Date: April 2012
Completed Date: June 2014
Phase: Phase 2
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