Safety and Efficacy of Gabapentin for Neuropathic Pain in Fabry Disease

NCT01588314 | Withdrawn Phase 2

• 1 other identifier: 1112M07943
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fabry Disease; Neuropathic Pain

Keywords

Fabry disease; neuropathic pain; gabapentin

Outcome Measures

Primary Outcomes (1)

• average reduction in hydrocodone-acetaminophen use

  assessed at the end of the study

Secondary Outcomes (3)

• Number and type of adverse events

  assessed at the end of the study

• Pain levels

  assessed at the end of the study

• Define therapeutic level for gabapentin

  assessed at the end of the study

Study Arms (2)

gabapentin

ACTIVE COMPARATOR

Drug: Gabapentin

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Gabapentin DRUG

gabapentin 100 mg capsules

Also known as: Neurontin

gabapentin

placebo DRUG

compounded placebo capsules

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of Fabry Disease
• age ≥ 18 years of age at study enrollment
• current neuropathic pain at any severity level

You may not qualify if:

• known sensitivity or allergy to study drug
• history of illicit drug use
• pregnancy
• suicidal thoughts at study enrollment as assess by the C-SSRS

Sponsors & Collaborators

• University of Minnesota: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

University of Minnesota, Fariview

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Fabry Disease; Neuralgia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Sphingolipidoses; Lysosomal Storage Diseases, Nervous System; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolism, Inborn Errors; Lipidoses; Lipid Metabolism, Inborn Errors; Lysosomal Storage Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jeanine R. Jarnes, PharmD

  University of Minnesota, Fairview

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

US (1)