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:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT00229632
Eligibility Criteria:
* INCLUSION CRITERIA:
Diagnosis of FA with confirmed FRDA mutations.
Age from nine up to but not over eighteen years.
Weight between 30 to 80 kilograms.
Ambulatory (assistance devices permitted).
Willing to participate in all aspects of trial design and follow-up.
All subjects agree and commit to the use of 2 reliable methods of birth control for the duration of the study if sexually active.
Neurologically symptomatic.
No exposure to idebenone, coenzyme Q10, or other dietary supplements for a period of at least one month before enrollment in the study.
EXCLUSION CRITERIA:
History of a hypersensitivity reaction to idebenone or coenzyme Q10.
Pregnant or lactating women. All women of child-bearing potential must have negative serum pregnancy prior to the medication phase of the study. If a minor has a positive pregnancy test, we will inform her but not inform her parents unless we are asked to by the minor.
Platelet count, white blood cell count or hemoglobin below the lower limit of normal.
Alkaline phosphatase, SGOT, or SGPT greater than 1.5 times the upper limit of normal. Bilirubin greater than 1.5 g/dl.
Creatinine greater than 1.5 times the upper limit of normal based upon the pediatric reference range provided by the testing laboratory.
Clinically significant medical disease that, in the judgment of the investigators, would expose the patient to undue risk of harm or prevent the patient from completing the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
17 Years
Study:
NCT00229632
Study Brief:
Protocol Section:
NCT00229632