N-Acetyl Cysteine for Multiple Sclerosis

(MSNAC Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Must be taking: Interferon, Glatiramer, Dimethyl fumarate, Teriflunomide

Must not be taking: Blood pressure, Blood clotting, Diabetes, Nitroglycerin

Disqualifiers: Brain surgery, Stroke, Tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

55 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether NAC, a cell-protecting supplement, can help MS patients by reducing cell damage in the brain. MS patients often experience nerve cell damage, and NAC may help by boosting a protective substance called glutathione. NAC has been explored in previous studies for its potential to improve brain glucose metabolism and blood flow in MS patients.

Research Team

Daniel A Monti, MD, MBA

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

This trial is for adults with relapsing remitting or progressive Multiple Sclerosis who can travel to Philadelphia. They should be physically independent and either not on MS medication, planning to start one, or on a stable regimen of certain disease-modifying drugs. Participants must use effective contraception if applicable and cannot have conditions that interfere with the study.

Inclusion Criteria

I am 18 years old or older.

I am using or will use effective birth control during the study.

Participants must be able to complete study procedures in the greater Philadelphia area

Exclusion Criteria

I've had brain surgery that may affect brain scans.

I take daily medication to manage my asthma.

You weigh more than the maximum weight allowed on the table.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a combination of intravenous and oral N-acetyl cysteine for 4 months

16 weeks

Weekly visits for IV administration, daily oral administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

2 visits (in-person)

Treatment Details

Interventions

• N-acetyl Cysteine

Trial Overview The trial tests whether N-acetyl cysteine (NAC) supports brain function in MS patients using advanced imaging techniques like PET-MRI scans. It aims to measure changes in cerebral metabolism and myelin structure after administering NAC.

Participant Groups

Group I: N-acetyl Cysteine Cohort Active Control 1 Intervention

Intravenous N-acetyl Cysteine - 50mg in 200ml of D5W over one hour 1 x per week Oral N-acetyl Cysteine - 1 500mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered)

Group II: Control Cohort Active Control 1 Intervention

Standard of Care Treatment

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+