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Senolytics for Secondary Progressive MS

Not Yet RecruitingPhase 1

Sponsor: Ohio State University

Conditions: Multiple Sclerosis (MS) Secondary Progressive

Interventions: Dasatinib and quercetin

Countries: United States

This is a clinical trial to see whether senolytic therapy is safe and feasible for patients with secondary progressive MS and whether treatment improves physical and thinking abilities. The study seeks to enroll adults with secondary progressive MS (SPMS), aged 50-85, who are not currently taking a MS disease-modifying therapy and have noticed their MS symptoms getting worse. People who join the study will take the medicines dasatinib and quercetin by mouth every two weeks for three months. These medicines work together to remove old, damaged cells that may cause inflammation and slow the repair of nerves. Participants will also be followed for one year from enrollment to monitor for treatment effects.

Eligibility overview

Sex: ALL

Age: 50 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Columbus, Ohio, United States