Status:
COMPLETED
Efficacy of Epoetin Alfa in Patients With Friedreich's Ataxia
Lead Sponsor:
Federico II University
Conditions:
Friedreich's Ataxia
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
Friedreich's ataxia is a rare genetic disorder characterized by severe neurological disability and cardiomyopathy. Friedreich's ataxia is the consequence of frataxin deficiency. Although several drugs...
Detailed Description
Friedreich ataxia (FRDA) is an inherited recessive disorder characterized by progressive neurological disability. FRDA is the consequence of frataxin deficiency. Although several drugs have been propo...
Eligibility Criteria
Inclusion
- Molecular diagnosis of FA based on a homozygous GAA expansion within the FRDA with a triplet repeat sequence in the pathological range.
- Age \>18, \<50 years
Exclusion
- Failure to meet one of the inclusion criteria
- Patients in treatment with Idebenone
- Wheelchair bound patients
- Significant renal, hepatic or haematological disease
- Positive history for arterial or venous thrombosis
- Acute diseases that might interfere with the study
- Positive history for arterial hypertension
- Present or programmed pregnancy
- Known hypersensitivity to study drug
- Other unacceptable concomitant medications (in particular agents thought to have a neuroprotective potential as tocopherol, amantadine, memantine, free radical scavengers).
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00631202
Start Date
February 1 2008
End Date
June 1 2009
Last Update
May 27 2010
Active Locations (1)
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1
Dipartimento di Scienze Neurologiche
Naples, Italy, 80131