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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT02660112
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of Friedreich's Ataxia (FA) by Frataxin genetic testing and/or Frataxin enzyme analysis
* Between age 10 and 50 years of age, inclusive
* Body weight of 25 kilograms or higher
* Minimum of one affected organ (cardiac or neurological) system, as evidenced by clinical signs/symptoms
* Disease duration ≤7 years, based on onset date of FA symptoms
* Has no known contraindication to gadolinium contrast such as severe allergy or Glomerular Filtration Rate \<30 ml/min/m\^2.
* Has no known contraindication to non-contrast Magnetic Resonance Imaging (MRI) evaluation such as pacemaker or magnetically active metal fragments.
* Women of childbearing age must:
* Have a negative pregnancy human chorionic gonadotropin test prior to receiving study drug.
* Agree to use contraception for the duration of the study drug dosing, plus 1 month after completion of the study.
Exclusion Criteria:
* Advanced cardiac failure, New York Heart Association (NYHA) Classification Scale-Class IV (advanced stage heart failure)
* Clinically significant comorbidities that may also lead to cardiomyopathy, for example long standing hypertension, familial cardiomyopathy.
* Clinically significant comorbidities that would, in the opinion of the investigators, compromise the interpretation of test results.
* Pregnant, breast-feeding or planning to become pregnant during study timeframe.
* Patients with contraindications to regadenoson, i. e. second- or third-degree atrioventricular (AV) block or sinus node dysfunction. Has received an investigational drug within thirty (30) days of baseline visit.
* Thrombocytopenia (\<125 x 10\^9/Liter) or prolonged Prothrombin Time/Partial Thromboplastin Time (PT/PTT) at baseline.
* Clinically significant hypotension (systolic blood pressure \<90) due to heart failure or other conditions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
50 Years
Study:
NCT02660112
Study Brief:
Protocol Section:
NCT02660112