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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT03952234
Eligibility Criteria:
Inclusion Criteria:
1. Clinical diagnosis of MELAS (stroke-like events, seizures, exercise intolerance or muscle weakness).
2. Subject must be aged 18 to 65 years.
3. The m.3243A\>G mutation in the MTTL1 gene.
4. Elevated plasma lactate (\>2.2 mmol/L) taken at any point in the screening period (6 months prior to screening visit, including and up to the baseline visit).
5. Negative urine pregnancy test, if applicable.
6. Score of 26 or higher on the Montreal Cognitive Assessment (MOCA). -
Exclusion Criteria:
1. Evidence of acute illness or physical disability that may interfere with their ability to undergo the study.
2. Tobacco use
3. Orthostatic hypotension defined as a decrease in systolic blood pressure of 20 mm Hg, or a decrease in diastolic blood pressure of 10 mm Hg, between one and three minutes of standing when compared with blood pressure from the sitting or supine position at the baseline visit.
4. Presence of the following signs or symptoms in the past 12 months at grade 3 or higher based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03: hypotension, syncope, dizziness, blurred vision, fatigue, concentration impairment, nausea, vomiting, diarrhea, hypoglycemia, or headache.
5. \> 2 seizures in week prior to baseline visit.
6. Hypotension defined as systolic blood pressure ≤ 90 mm Hg or diastolic blood pressure ≤ 60 mm Hg at the baseline visit.
7. Arginine supplementation within one week prior to baseline visit.
8. Inability to travel to the study site.
9. Subjects with no evidence of neurological disease, muscle weakness, or exercise intolerance.
10. Subjects with evidence of moderate to severe renal impairment ( eGFR \< 60 mL/min/1.73 m2 ) at the baseline visit.
11. Subjects with poor cognitive ability to provide consent and to understand and report hypoglycemia.
12. Unwillingness of sexually active female subjects of childbearing age to practice reliable methods of contraception.
13. Intake of drugs that increase NO synthesis, vasodilators, or amino acid supplements that cannot be stopped during the study period.
14. Positive urine pregnancy test.
15. Score of less than 26 on the Montreal Cognitive Assessment (MOCA). -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03952234
Study Brief:
Protocol Section:
NCT03952234