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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:Select...
I currently have active stomach or intestinal ulcers.
Select...
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.
Select...
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
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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have active stomach or intestinal ulcers.My disability level is moderate to severe but I can still walk.My symptoms have been getting worse for at least 2 years.I've been on a stable treatment for my condition for over 3 months.My mobility or cognitive function has worsened in the last 2 years not due to relapses.I have a history of bleeding disorders.I am between 40 and 70 years old.I am currently being treated for cancer or was treated for spreading cancer in the last year.My condition is progressive MS.I have taken oral steroids in the last 3 months.I am taking supplements or medications with antioxidant properties.I have had an MS flare-up in the last 6 months.I cannot use birth control during the study.I have been taking dalfampridine for at least one month without changing the dose.I am not planning any surgery or to move in the next 15 months.
Research Study Groups:
This trial has the following groups:- Group 1: N-acetyl cysteine
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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