Neuropathic Pain and Fabry Disease

This study has been completed.
Sponsor:
Information provided by:
Danish Pain Research Center
ClinicalTrials.gov Identifier:
NCT00168974
First received: September 13, 2005
Last updated: November 15, 2007
Last verified: November 2007

September 13, 2005
November 15, 2007
January 2004
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Complete list of historical versions of study NCT00168974 on ClinicalTrials.gov Archive Site
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Neuropathic Pain and Fabry Disease
Somatosensoric and Autonomic Disturbances in Female Patients With Fabry Disease

Fabry disease is a rare X-linked lysosomal storage disorder. The mutations result in a deficiency of the lysosomal enzyme α-galactosidase causing accumulation of glycosphingolipids in the vascular endothelial cells and many other tissues. An early sign of the disease is painful small fibre neuropathy presenting in two forms: 1. a constant burning sensation in the hand and feet and 2. Fabry crises consisting of attacks of excruciating pain. Given the X-linked inheritance, male patients are severely affected. Recently attention has been drawn to female patients whether they also show signs of nerve involvement.

The purpose of this study is to evaluate the small fibre neuropathy in female Fabry patients. Correlation with X-chromosome inactivation will be attempted. Recombinant human α-galactosidase A is now available for patients. A part of this study is evaluation the long term efficacy of enzyme replacement therapy in female patients with Fabry disease and neuropathy.

Male family members with Fabry disease will be examined.

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Observational
Time Perspective: Prospective
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Fabry Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
November 2007
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Inclusion Criteria:

  • All adult patients with confirmed Fabry disease

Exclusion Criteria:

  • Patients who cannot cooperate
  • Patients who are unable to understand the purpose
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00168974
Fabry2003
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Danish Pain Research Center
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Principal Investigator: Anette T Moller, MD Danish Pain Research Center
Study Chair: Troels S Jensen, MD, PhD Danish Pain Research Center
Danish Pain Research Center
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP