Safety and Efficacy of Gabapentin for Neuropathic Pain in Fabry Disease

Neuropathic Pain Clinical Trial

Official title:

Placebo Controlled Trial Evaluating Gabapentin for the Treatment of Small Fiber Neuropathic Pain in Patients With Fabry Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01588314
• Other study ID #: 1112M07943
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: May 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fabry Disease
• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Gabapentin
gabapentin 100 mg capsules
• placebo
compounded placebo capsules

Locations

Country	Name	City	State
United States	University of Minnesota, Fariview	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average reduction in hydrocodone-acetaminophen use		assessed at the end of the study
Secondary	Number and type of adverse events		assessed at the end of the study
Secondary	Pain levels		assessed at the end of the study
Secondary	Define therapeutic level for gabapentin		assessed at the end of the study