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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01588314
Other study ID # 1112M07943
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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