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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT07270120
Eligibility Criteria:
Inclusion Criteria:
1. Individuals aged 50-85 with SPMS diagnosed using the 2024 McDonald Criteria
2. Not treated with a DMT for MS within the last 6 months or have used alemtuzumab, cladribine, or mitoxantrone.
3. Evidence of MS progression over the past 12 months.
Exclusion Criteria:
1. Unstable coronary artery disease (myocardial infarction within 6 months or angina)
2. Hospitalization within 6 months
3. Stroke or transient ischemic attack in the past 6 months
4. Pulmonary arterial hypertension
5. Current or chronic history of liver disease
6. Alzheimer's or Parkinson's disease
7. Drug or alcohol abuse in the previous 5 years
8. History of coagulation disorders, central nervous system hemorrhage, or gastrointestinal hemorrhage
9. History of angina or myocardial infarction, arrhythmia, or heart failure at any time
10. QTc prolongation
11. Anemia (Hgb\<9), thrombocytopenia (platelets\<50,000 per microliter), or neutropenia (ANC\< 1000 per microliter)
12. Moderate hypokalemia (2.9 mmol/L) and moderate hypomagnesemia (0.9-1.1 mg/dL or 0.37-0.45 mmol/L)
13. ALT/AST \>1.5x ULN, total bilirubin \>ULN, and alkaline phosphatase \>2x ULN
14. Chronic renal disease (glomerular filtration rate \< 30 mL/min/1.73 m2)
15. Alcohol intake greater than 2 drinks/day for men and greater than 1 drink/day for women
16. Anti-arrhythmic medications known to cause QTc prolongation
17. Antipsychotics and anxiolytics
18. Anti-platelet or anti-coagulant medications other than aspirin
19. Quinolone antibiotics
20. Pregnant or lactating subjects or subjects intending to become pregnant or to donate egg/sperm
21. Participants with p16INK4a below the median of SPMS patients in the OSU Aging and MS Cohort
22. Use of drugs metabolized by the same liver enzymes as D or Q
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT07270120
Study Brief:
Protocol Section:
NCT07270120