Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT00631202
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00631202
Study Brief:
Protocol Section:
NCT00631202