Safety and Efficacy of Gabapentin for Neuropathic Pain in Fabry Disease
| Status: | Withdrawn |
|---|---|
| Conditions: | Neurology, Hematology, Metabolic |
| Therapuetic Areas: | Hematology, Neurology, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/22/2018 |
| Start Date: | April 2012 |
| End Date: | June 2014 |
Placebo Controlled Trial Evaluating Gabapentin for the Treatment of Small Fiber Neuropathic Pain in Patients With Fabry Disease
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.
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.
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.
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.
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
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