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:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT02333305
Eligibility Criteria:
Inclusion criteria :
* 1\. Diagnosis of ataxia with oculomotor apraxia type I (AOA1) confirmed by genetic molecular analysis
* 2\. Age ≥ 18 years
* 3\. Hypoalbuminemia
* 4\. Efficient contraception for women of childbearing potential (with pregnancy test during each visit)
* 5\. Signature of the written informed consent form
* 6\. Presence of a support person (for patient with cognitive disorders)
Exclusion criteria :
* 1\. Hypersensitivity to one of the excipients (glycerin, ethanol, lecithin)
* 2\. Absence of hypoalbuminemia
* 3\. During the 2 months before inclusion :
* Use of CoQ10
* Treatment with antioxidants (vitamin C) and statins
* Use of drugs affecting mitochondrial activity
* Anti-cholesterol, thyroid hormones, anti-arrhythmic compounds, warfarin, metformin or clozapine
* 4\. Treatment with vitamin E, calcium, magnesium and/or other vitamins with a concentration superior to 149 UI during more than 3 months before inclusion
* 5\. Use of drugs interfering with catacholamine metabolism (reserpine, amphetamine, or inhibitors of the monoamine oxidase A, methylphenidate, cinnarizine) during the month before inclusion
* 6\. Non balanced treatment with anxiolytics, hypnotics, tranquillizers and/or antidepressants during the month before inclusion
* 7\. Hypothyroidism with thyroxin use
* 8\. Epilepsy
* 9\. Psychotic disorders
* 10\. Pregnancy or lactation period
* 11\. Woman of childbearing potential without efficient contraception
* 12\. Participant to other therapeutic studies during the month before inclusion
* 13\. Inability to receive a clear information on the research
* 14\. Inability to participate to the totality of the study
* 15\. Non affiliation to social security (beneficiary or assignee)
* 16\. Refusal of signing the consent form
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02333305
Study Brief:
Protocol Section:
NCT02333305