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 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT01016366
Eligibility Criteria:
Inclusion Criteria:
* The patient has been diagnosed with FRDA and has had a genetic test demonstrating \>400 GAA nucleotide triplet repeats on the shorter of the two frataxin alleles
* The patient has a SARA (Stance) sub-score of \<=6
* The patient has a SARA (Gait) sub-score of \<=6
* Man or woman, aged 18 years or over
* If female then woman should agree not to try to become pregnant during the study, and use adequate protection/abstinence or not be of child bearing potential
Exclusion Criteria:
* Clinically significant unstable illnesses such as liver, kidney, heart, stomach problems unrelated to their disease of FRDA
* Disallowed medications
* Serious underlying disease
* Clinically significant abnormal vital signs unrelated to the underlying disease of FRDA
* Abnormal laboratory blood results considered by the doctor as clinically significant, e.g.anaemia
* Treatment with idebenone within 6 weeks prior to screening
* Treatment with erythropoietin within 16 weeks prior to screening
* Clinically significant abnormal ECG
* Received or donated blood within previous 3 months
* Participation within another clinical trial within past 30 days
* Pregnancy or breast feeding
* History of drug allergies or hypersensitivities
* Current (or within past 6 months) disorder related to drug or alcohol abuse (as defined DSM-IV-TR)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01016366
Study Brief:
Protocol Section:
NCT01016366