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 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
NCT ID:
NCT06474104
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, age 3 to 85 years.
2. For patients with Primary Mitochondrial Disease:
a. Clinical diagnosis of PMD confirmed by mtDNA sequencing.
3. For Healthy Volunteers:
1. Normal Vital signs and BMI for age
2. No active medical conditions or diseases
3. No current medications, other than acetaminophen and naproxen sodium
4. For All Subjects:
1. No viral or bacterial illness in past 2 weeks
2. No antibiotic or antiviral medications in past 2 weeks
3. No blood transfusion in past 2 weeks
4. No current pregnancy
5. Not currently breastfeeding
6. Alcohol use less than 2 drinks / day
7. No recreational or illicit drug use in previous 1 year
8. No tobacco or nicotine containing products in previous 1 year
5. Patient, parent or guardian able to understand and provide voluntary written informed consent.
Exclusion Criteria:
1\. History of prior treatment with allogeneic hematopoietic stem cell transplantation, or gene therapy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
85 Years
Study:
NCT06474104
Study Brief:
Protocol Section:
NCT06474104