Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis (NCT05122559) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis
United States98 participantsStarted 2022-02-16
Plain-language summary
This study evaluates the effectiveness of N-acetyl cysteine (NAC) in the treatment of progressive multiple sclerosis. Half of the patients will receive NAC, while the other half will receive a placebo.
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- 40-70 (inclusive) years in age,
* meet 2017 McDonald criteria (Thompson 2018),
* patients with primary or secondary progressive MS (Thompson 2018),
* at least 2 years since progressive symptom onset,
* evidence of clinical changes over the previous 2 years unrelated to relapses: increased EDSS or 20% slowing on 25-foot walk, change of ambulatory support, cognitive change documented on cognitive testing. Progression defined by patients in terms of ambulation perimeter or type of support to ambulate are acceptable if aforementioned physician-based measure changes are not available.
* EDSS score 3.0 to 7.0 (inclusive),
* can be on a stable disease-modifying treatment initiated \> 3 months prior to screening,
* can be on stable doses of dalfampridine initiated at least one month before screening.
Exclusion Criteria:
* \- MS relapses in the previous 6 months
* oral glucocorticosteroid treatment within the prior 3 months
* patient with issues undergoing MRI scans
* pregnancy or breastfeeding
* women of child-bearing potential not able to utilize an effective form of contraception for the duration of the study
* history of bleeding disorders
* active gastrointestinal ulcers
* abnormal liver function testing (aminotransferase (AST) or alanine aminotransferase (ALT) \>2 times upper limit of normal)
* current treatment for active malignancy or metastatic malignancy treated in the past year
* alcohol or substance use disorder
* allergy to NAC
* planned surger…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability
Timeframe: 15 months
2
Effect of NAC on on progression of brain, thalamic and cervical cord atrophy