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This study examines iron-chelation therapy, which aims to bind and remove excess iron that builds up in the body, in patients with Friedreich ataxia. It enrolled patients aged 13 and older whose frataxin gene mutation was molecularly confirmed and who had iron overload. The research was conducted in Phase 1/Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Minimum age: 13 years 2. Molecular confirmation of frataxin gene mutation 3. Iron overload evaluation 4. Presence of lactate 5. Echography response to Idebenone treatment 6. Urinary test of pregnancy for girls 7. Sexual abstinence for men 8. Information consent Exclusion Criteria: 1. No disturbance of iron metabolism 2. No response to Idebenone 3. Friedreich not confirmed 4. Polynuclear neutrophils \<2 x 109/L or hemoglobin \< 8g/dL 5. No participation to other trial 6. Doubt regarding the compliance of the patient to protocol 7. Impossibility to undergo X-ray examination or presence of iron material in the backbone 8. Pregnant women 9. Absence of social insurance.