Placebo Controlled Trial Evaluating Gabapentin for the Treatment of Small Fiber Neuropathic Pain in Patients With Fabry Disease
Overview
- Phase
- Phase 2
- Intervention
- Gabapentin
- Conditions
- Fabry Disease
- Sponsor
- University of Minnesota
- Locations
- 1
- Primary Endpoint
- average reduction in hydrocodone-acetaminophen use
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed Description
Fabry disease is an X-linked lysosomal storage disorder which results from reduced activity of the enzyme α-galactosidase A. This reduced enzyme activity results in accumulation of globotriaosylceramide (GL-3), which causes disturbances in multiple organ systems. Patients often complain of acroparesthesia, caused by small-fiber neuropathy. Limited information is available regarding effective treatments for small-fiber neuropathic pain in Fabry disease, and no standard-of-care has yet been established. Opioid analgesics are often used because of their pharmacokinetic properties. While effective, the use of opioids has complications such as constipation, physical dependence and addiction. The purpose of this study is to determine efficacy of gabapentin vs. placebo at controlling peripheral neuropathic pain and reducing the 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 hydrocodone-acetaminophen use.
Investigators
Eligibility 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
Arms & Interventions
gabapentin
Intervention: Gabapentin
placebo
Intervention: placebo
Outcomes
Primary Outcomes
average reduction in hydrocodone-acetaminophen use
Time Frame: assessed at the end of the study
Secondary Outcomes
- Pain levels(assessed at the end of the study)
- Number and type of adverse events(assessed at the end of the study)
- Define therapeutic level for gabapentin(assessed at the end of the study)