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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if N-acetyl cysteine (NAC) can support brain function in people with Multiple Sclerosis (MS). MS damages the protective layer around nerve cells, often leading to movement and coordination issues. Researchers seek to discover if NAC can reduce brain damage caused by excess oxygen or inflammation. This trial suits individuals with MS who can walk independently and do not plan to change their current MS medications. Participants must be able to travel to the greater Philadelphia area for the study. As an unphased trial, it offers a unique opportunity to contribute to pioneering research that could enhance brain health for those with MS.

Do I need to stop my current medications for the trial?

The trial does not specify that you need to stop your current medications, but you should not plan to start new medications during the study. If you are taking medications that might interact with N-acetyl cysteine, the study doctor will evaluate your situation individually.

Is there any evidence suggesting that N-acetyl cysteine is likely to be safe for humans?

Research has shown that N-acetyl cysteine (NAC) is generally safe for people with multiple sclerosis (MS). In past studies, patients taking NAC reported few side effects. For instance, one study found that NAC was well tolerated and might help reduce tiredness and boost antioxidant levels in the blood. Another study discovered that NAC helped lower signs of oxidative stress (damage from too much oxygen) and improved anxiety symptoms in MS patients. While side effects can occur, these findings suggest that NAC is safe for many people with MS. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about N-acetyl Cysteine (NAC) for multiple sclerosis because it offers a unique approach compared to standard treatments. Unlike typical therapies that mainly focus on modulating the immune system, NAC works as an antioxidant, potentially reducing oxidative stress and damage in the nervous system. This dual delivery method—both intravenous and oral—might allow for more consistent therapeutic levels in the body, offering a flexible and potentially more effective treatment regimen. Plus, NAC is already known for its safety profile in other conditions, which could speed up its acceptance if proven effective for multiple sclerosis.

What evidence suggests that N-acetyl cysteine might be an effective treatment for Multiple Sclerosis?

Research has shown that N-acetyl cysteine (NAC) might support brain health and reduce oxidative damage in people with Multiple Sclerosis (MS). One study found that NAC improved the brain's ability to use sugar in MS patients, enhancing brain function. Another study demonstrated that NAC reduced signs of oxidative damage and alleviated anxiety in MS patients. Additionally, NAC may help with fatigue in individuals with progressive MS and boost antioxidant levels. In this trial, participants in the N-acetyl Cysteine Cohort will receive NAC treatment, while those in the Control Cohort will receive standard care. These findings suggest that NAC could benefit those with MS by protecting the brain and reducing symptoms. ^{1 3 6 7 8}

Who Is on the Research Team?

Daniel A Monti, MD, MBA

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

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 using or will use effective birth control during the study.

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

I can walk and move around on my own.

Exclusion Criteria

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

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

I take daily medication to manage my asthma.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7033492/

N-acetyl Cysteine Administration Is Associated With Increased ... The results of this study suggest that NAC positively affects cerebral glucose metabolism in MS patients, which is associated with qualitative, patient ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37386885/

Effects of N-acetylcysteine on oxidative stress biomarkers ... Based on the findings of the present study, NAC supplementation for 8 weeks decreased lipid peroxidation and improved anxiety symptoms in MS patients.

3. neurology.org neurology.org/doi/10.1212/WNL.92.15_supplement.P5.2-093

N-acetyl cysteine for fatigue in progressive multiple sclerosis NAC was well tolerated in progressive MS, with suggestion for sustained fatigue improvement and a positive antioxidant biomarker effect.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1551714422002671

Study protocol for a randomized, double-blind, placebo ... The proposed MRI outcomes were chosen based on their known changes in progressive MS and their potential sensitivity to volumetric changes due to neuronal loss ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05122559

Neuroprotection With N-acetyl Cysteine for Patients With ... This study evaluates the effectiveness of N-acetyl cysteine (NAC) in the treatment of progressive multiple sclerosis. Half of the patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8045913/

A pilot study of oxidative pathways in MS fatigue NAC was well‐tolerated in progressive MS, although reduction in fatigue on NAC was similar to placebo. Antioxidant blood and MRS biomarkers were not ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10496087/

Effects of N‐acetylcysteine on oxidative stress biomarkers ... N‐acetylcysteine (NAC) supplementation for 8 weeks decreased lipid peroxidation and improved anxiety symptoms in multiple sclerosis (MS) patients.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05122559

NCT05122559 | Neuroprotection With N-acetyl Cysteine for ... This study evaluates the effectiveness of N-acetyl cysteine (NAC) in the treatment of progressive multiple sclerosis. Half of the patients will receive NAC, ...