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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT04801303
Eligibility Criteria:
Inclusion Criteria:
* Patients with Friedreich's Ataxia and confirmed genetic diagnosis with:
* Two pathological GAA triplet repeats in the gen FXN
* One pathological GAA triplet repeat and one point mutation in the gen FXN
* Patients between 16 and 65 years of age.
* To keep the walking ability, although an external aid is needed.
* Women with confirmed genetic diagnosis must use an effective contraceptive method during the trial.
Exclusion Criteria:
* Any neurological or other kind of disease that could interfere in the trial according to the investigator judgement.
* Severe visual loss.
* Severe auditory loss.
* Cognitive decline\*.
* Dementia or affective-cognitive cerebellar syndrome.
* Serious psychiatric illness during the six previous months of the trial inclusion.
* Substance abuse during the six previous months of the trial inclusion.
* Severe drug allergy.
* Cardiac disease:
* Ejection fraction \<40% \[N: 50-70%\]
* Heart failure \> 2 from NYHA (New York Heart Association) criteria.
* Significant valvular heart disease.
* Symptomatic coronary artery disease.
* Cardiac arrhythmia with hemodynamic compromise (atrial fibrillation).
* Prolonged immobilisation
* Use of research drugs during the 30 previous days of the trial inclusion.
* Concomitant treatment with digoxin, thiazide diuretics, cholestyramine, corticoids, laxatives with magnesium, barbiturates and antiepileptic drugs. Use of Calcium or Vitamin D drugs during the 30 previous days of the trial inclusion.
* Legally or mentally incapacitated person.
* In women:
* Positive pregnancy test.
* Maternal breastfeeding.
* Blood test alteration:
* Hypercalcemia.
* Elevated creatinine.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT04801303
Study Brief:
Protocol Section:
NCT04801303