What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies such as dimethyl fumarate (BG-12), glatiramer acetate, and N-acetyl cysteine (NAC). Dimethyl fumarate can cause side effects like flushing, gastrointestinal issues, and lymphopenia. Glatiramer acetate may lead to injection site reactions, chest pain, and lipoatrophy. N-acetyl cysteine, an antioxidant studied for its potential benefits in MS, is generally well-tolerated but can cause gastrointestinal disturbances, rash, and, rarely, anaphylactic reactions. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

FDA-approved treatments for Multiple Sclerosis (MS) include a variety of disease-modifying therapies that target different aspects of the disease. While N-acetyl cysteine (NAC) is being studied for its antioxidant properties, other FDA-approved treatments with similar mechanisms include dimethyl fumarate (BG-12), which has antioxidant effects and reduces oxidative stress. Dimethyl fumarate is known to activate the Nrf2 pathway, leading to the upregulation of antioxidant response elements. Other commonly approved treatments for MS include interferon-beta, glatiramer acetate, and monoclonal antibodies like natalizumab and ocrelizumab, which primarily focus on modulating the immune response rather than directly targeting oxidative stress.

What other types of research exist?

Promising novel alternatives to N-acetyl cysteine for Multiple Sclerosis patients include dimethyl fumarate (BG-12), which has shown significant reductions in relapse rates and new brain lesions, and carnitine supplementation, which may improve fatigue. Both treatments have demonstrated potential benefits in clinical trials and could be considered as alternatives in 2024.

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Antioxidant

N-acetyl Cysteine for Multiple Sclerosis (NACPMS Trial)

Phase 2

Recruiting

Research Sponsored by Emmanuelle Waubant

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Active gastrointestinal ulcers

History of bleeding disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Summary

This trial tests if N-acetyl cysteine (NAC) can help people with progressive multiple sclerosis by protecting brain cells and reducing inflammation. Participants will be divided into two groups, with one group taking NAC. N-acetyl cysteine (NAC) has been studied for its potential benefits in various conditions, including multiple sclerosis, cannabis use disorder, and chronic obstructive pulmonary disease.

Who is the study for?

This trial is for adults aged 40-70 with primary or secondary progressive multiple sclerosis, as per the McDonald criteria. Participants must have experienced progression in the last 2 years and not had MS relapses in the past 6 months. They should not be pregnant, planning surgery, moving soon, or have certain medical conditions like liver issues or bleeding disorders.

What is being tested?

The study is testing N-acetyl cysteine (NAC) to see if it can protect nerve cells in patients with progressive multiple sclerosis. Half of the participants will receive NAC while the other half will get a placebo to compare effects.

What are the potential side effects?

Potential side effects of N-acetyl cysteine may include allergic reactions for those sensitive to it, digestive discomfort such as nausea or vomiting, and possibly headaches or dizziness.

Eligibility Criteria

Exclusion Criteria

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

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I currently have active stomach or intestinal ulcers.

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I have a history of bleeding disorders.

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I am currently being treated for cancer or was treated for spreading cancer in the last year.

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I cannot use birth control during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Effect of NAC on on progression of brain, thalamic and cervical cord atrophy

Safety and tolerability

Secondary study objectives

Clinical effects of NAC

Other study objectives

Effect of NAC on progression of MS

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: N-acetyl cysteineActive Control1 Intervention

N-acetyl cysteine (NAC) 1200mg t.i.d.

Group II: PlaceboPlacebo Group1 Intervention

Placebo 1200mg t.i.d.

0 / 4Eligibility 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

Common treatments for Multiple Sclerosis (MS) often focus on reducing oxidative stress and inflammation, which are key factors in the disease's progression. N-acetyl cysteine (NAC) replenishes glutathione levels, thereby reducing oxidative stress and inflammation. Similarly, dimethyl fumarate activates the Nrf2 pathway to combat oxidative stress, while glatiramer acetate modulates the immune response to decrease inflammation. These mechanisms are vital for MS patients as they help manage symptoms, slow disease progression, and improve overall quality of life by addressing the underlying causes of the disease.