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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT02274051
Eligibility Criteria:
Inclusion Criteria:
1. Male of female patients aged 16 and older
2. Confirmed diagnosis of familial dysautonomia by genetic testing
3. Written informed consent to participate in the trial and understanding that they can withdraw consent at anytime without affecting their future care.
4. Ability to comply with the requirements of the study procedures.
Exclusion Criteria:
1. Patients who have taken other nutritional supplements that may affect IKAP mRNA splicing within the last 30 days
2. Patients with a known hypersensitivity to any component of the nutritional supplement kinetin
3. Patients with atrial fibrillation, angina or an electrocardiogram documenting significant abnormality that may jeopardize the patient's health.
4. Patients with significant pulmonary, liver, renal (creatinine \>2.5 mg/ml) or cardiac illness
5. Women who are pregnant or lactating
6. Women of childbearing potential who are not using medically accepted methods of contraception.
7. Patients who have a significant abnormality on clinical examination that may, in the investigator's opinion, jeopardize their healthy participating in this pilot trial.
8. Patients taking allopurinol, other xanthine oxidase inhibitors or other compounds that may interfere with the metabolism of kinetin including oral calcium supplements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT02274051
Study Brief:
Protocol Section:
NCT02274051