What is the mechanism of action of this treatment?

Multiple Sclerosis (MS) treatments often target the immune system to reduce inflammation and prevent further damage to the myelin sheath surrounding nerve cells. Antioxidants like N-acetyl cysteine (NAC) help mitigate oxidative stress by neutralizing free radicals, which can damage cells and exacerbate MS symptoms. Anti-inflammatory agents reduce the immune system's attack on the nervous system, thereby decreasing inflammation and slowing disease progression. These mechanisms are crucial for MS patients as they help manage symptoms, reduce relapses, and improve overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) with antioxidant and anti-inflammatory properties include glatiramer acetate and dimethyl fumarate. Glatiramer acetate can cause side effects such as injection site reactions, flushing, chest pain, and, rarely, hepatotoxicity. Dimethyl fumarate is associated with gastrointestinal issues (nausea, diarrhea, abdominal pain), flushing, and a potential decrease in lymphocyte counts. Both treatments aim to modulate the immune response and reduce inflammation, similar to the proposed effects of N-acetyl cysteine (NAC).

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Sclerosis (MS), including glatiramer acetate and dimethyl fumarate. Glatiramer acetate works by modulating the immune response, while dimethyl fumarate has both anti-inflammatory and antioxidant properties, making it somewhat similar to N-acetyl cysteine (NAC). Dimethyl fumarate reduces relapse rates and the development of new brain lesions in patients with MS. These treatments aim to manage symptoms and slow disease progression.

What other types of research exist?

Promising novel alternatives to N-acetyl cysteine (NAC) for Multiple Sclerosis patients include: 1) Danshensu-cysteine conjugates (DSC) and its diastereoisomers, which have shown potent anti-oxidative and anti-apoptotic effects. 2) Melatonin-sulforaphane hybrid (ITH12674), which has demonstrated improved neuroprotective properties in oxidative stress conditions. 3) Novel thiol-containing hybrid NO donor-antioxidants (e.g., bSA-9 and bSA-10), which provide efficient protection from oxidative stress while maintaining nitric oxide bioavailability.

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Antioxidant

N-Acetyl Cysteine for Multiple Sclerosis (MSNAC Trial)

N/A

Waitlist Available

Led By Daniel A Monti, MD, MBA

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Physically independent, ambulatory

Be older than 18 years old

Must not have

Previous brain surgery that would interfere with determination of cerebral metabolism or structure on the FDG PET-MRI

History of asthma requiring daily medications for adequate management

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 60 ± 30 days

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions related to the MRI contrast agent used during scans, as well as general side effects from NAC such as nausea, vomiting, rash or headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk and move around on my own.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I take daily medication to manage my asthma.

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I don't have brain conditions that could affect scan readings.

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I have had a head injury that made me unconscious for more than 48 hours.

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I don't have any health issues that could affect MS symptom evaluation or study tests.

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I have not had IV steroids in the last 90 days for conditions other than MS.

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I am scheduled for surgery during the study period.

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I cannot walk and use a wheelchair or stay in bed.

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I have a history of high blood pressure in the lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 60 ± 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 60 ± 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 60 ± 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in the metabolic activity in the brain, and improved parameters with regard to the inflammation associated with the active lesions based on both MRI and PET findings.

Secondary study objectives

Bladder Control Scale (BLCS)

Bowel Control Scale (BWCS)

Health Status Questionnaire (SF-36) standard form

+10 more

Trial Design

2Treatment groups

Active Control

Group I: N-acetyl Cysteine CohortActive Control1 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 CohortActive Control1 Intervention

Standard of Care Treatment

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Sclerosis (MS) treatments often target the immune system to reduce inflammation and prevent further damage to the myelin sheath surrounding nerve cells. Antioxidants like N-acetyl cysteine (NAC) help mitigate oxidative stress by neutralizing free radicals, which can damage cells and exacerbate MS symptoms. Anti-inflammatory agents reduce the immune system's attack on the nervous system, thereby decreasing inflammation and slowing disease progression. These mechanisms are crucial for MS patients as they help manage symptoms, reduce relapses, and improve overall quality of life.

Failed, Interrupted, or Inconclusive Trials on Immunomodulatory Treatment Strategies in Multiple Sclerosis: Update 2015-2020.