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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 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.

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.

Find a Location

Who is running the clinical trial?

Emmanuelle WaubantLead Sponsor
Emmanuelle Waubant, MD PhDLead Sponsor
United States Department of DefenseFED
908 Previous Clinical Trials
333,582 Total Patients Enrolled
12 Trials studying Multiple Sclerosis
2,736 Patients Enrolled for Multiple Sclerosis

Media Library

N-acetyl cysteine (Antioxidant) Clinical Trial Eligibility Overview. Trial Name: NCT05122559 — Phase 2
Multiple Sclerosis Research Study Groups: N-acetyl cysteine, Placebo
Multiple Sclerosis Clinical Trial 2023: N-acetyl cysteine Highlights & Side Effects. Trial Name: NCT05122559 — Phase 2
N-acetyl cysteine (Antioxidant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05122559 — Phase 2
~29 spots leftby Feb 2026