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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01178164
Other study ID # CHUBX 2010/04
Secondary ID
Status Completed
Phase N/A
First received August 4, 2010
Last updated April 3, 2013
Start date September 2010
Est. completion date September 2012

Study information

Verified date April 2013
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

Fabry disease (FD) is a rare X-linked multisytemic lysosomal disorder caused by alpha-galactosidase deficiency. Globotriaosylcéramide (Gb3) deposits are observed in almost all tissues examined. Signs of the disease appear earlier and are more severe in affected males than in females. Myocardiopathy, renal failure and neurological signs including chronic pain and peripheral neuropathies are the most frequent signs. The availability of two enzymatic replacement therapies now provides a specific and effective treatment for patients. The prevalence of FD is estimated between 1/40,000 and 1/117,000. The frequency of Fabry disease has previously been estimated in several series of patients presenting one single sign, ie renal failure, hypertrophic myocardiopathy and early onset stroke. However, no data are available about the prevalence of FD in populations of patients suffering from chronic pains of unknown origin.

The diagnosis of FD will be performed by standard procedures following international recommendations. These require the search for a deficiency of alphagalactosidase A activity on leucocytes in males and genetic analysis of the GLA gene in females (Lidove et al. 2007).

The patients in whom the diagnosis of FD is established during this study, will be call in for an additional visit in the Investigating Centre in order to confirm the diagnosis and propose suitable assessment and care.


Recruitment information / eligibility

Status Completed
Enrollment 137
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 65 Years
Eligibility Inclusion Criteria:

- patients of both sex

- aged from 6 to 65

- with chronic pains of unknown aetiology including:

- acroparesthesias

- and/or pain crises evolving more than 3 months

- continued neuropathic evolving more than 3 months

- and/or multiple pains evolving more than 3 months

- and/or recurrent abdominal crises of pain who come for a clinical visit in the Centre Douleurs Chroniques in the CHU of Bordeaux.

Exclusion Criteria:

- chronic pain of known cause

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Genetic:
Blood sampling for biological and genetic analysis
Clinical examination Blood sampling for biochemical enzymatic measures of alphagalactosidase A activity in males, and genetic analysis using direct sequencing of GLA in females.

Locations

Country Name City State
France Centre Douleurs Chroniques, Hopital Pellegrin Bordeaux Cedex

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis of Fabry disease in one patient suffering from chronic pains 1 year No
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