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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT02424435
Eligibility Criteria:
Inclusion Criteria:
* Subjects with FRDA confirmed by genetic testing who are able to walk 25 feet (assistive devices allowed).
* Children between ages 5 and less than 10 years or adults ages 45 years and older at screening.
* Stable doses of all medications, vitamins and supplements for 30 days prior to study entry and for the duration of the study. Throughout the study, all possible efforts will be made to maintain stable doses of concomitant medications.
* Females who are not pregnant or breast feeding, and who do not intend to become pregnant. Females of child-bearing potential must use a reliable method of contraception and must provide a negative urine pregnancy test at screening.
* Informed consent for adult participants, parent/guardian permission (informed consent) and child assent for pediatric participants.
Exclusion Criteria:
* Patients unable to walk 25 feet.
* Treatment with methylprednisolone or cyclic methylprednisolone during the 3 previous months before inclusion.
* Treatment with gamma interferon, immunoglobulin G or other immunomodulating treatment the 3 previous month before inclusion
* Immunosuppressive treatment within 6 month of inclusion
* Prior history of a disease associated with immune dysfunction
* Poorly controlled Diabetes Mellitus (HbA1C \> 9.0)
* History of untreated or uncontrolled hypertension
* Presence of infectious disease or other active infections which the treating physician finds relevant
* Active or previous history of liver or renal failure
* Known history of renal insufficiency or creatinine \> 2 x upper limit of normal (ULN)
* Active infection at time of screening
* History of known osteoporosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT02424435
Study Brief:
Protocol Section:
NCT02424435