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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT05962333
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Age: 18-64
* Sex: male/female
* Patients with the m.3243A\>G mutation load of 50%-90% determined in skeletal muscle or derived from age-corrected calculation of blood m.3243A\>G mutation load
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Use of dabigatran, apixaban, edoxaban or rivaroxaban (DOACs) as anti-coagulants
* Have a weekly alcohol intake of ≥ 35 units (men) or ≥ 24 units (women)
* Current history of drug abuse
* Deficient immune system or autoimmune disease
* Significant concurrent illness
* Ongoing participation in other clinical trials with intervention
* Pregnant or lactating women
* Psychiatric or other disorders likely to impact on informed consent
* Patients unable and/or unwilling to comply with treatment and study instructions
* A history of strokes with signs of extra-pyramidal or pyramidal syndrome
* Allergy for contrast fluid
* Peripheral signs of ischemia or vasculopathy
* Claustrophobia
* Metal implants
* Any other factor that in the opinion of the investigator excludes the patient from the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT05962333
Study Brief:
Protocol Section:
NCT05962333