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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT00905268
Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of FRDA with confirmed FRDA mutations
* Patients 8 years of age or older at baseline
* Patients with body weight ≥ 25kg
* Patients who in the opinion of the investigator are able to comply with the requirements of the study, including swallowing the medication
* Negative urine pregnancy test at screening and at baseline (women of childbearing potential)
Exclusion Criteria:
* Treatment with idebenone or Coenzyme Q10 within the past 1 month
* Pregnancy and/or breast-feeding
* Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal of SGOT, SGPT, or creatinine
* Past or present history of abuse of drugs or alcohol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT00905268
Study Brief:
Protocol Section:
NCT00905268