Using N-acetyl cysteine to protect nerves in patients with progressive multiple sclerosis

Randomized Controlled Trial of N-acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple Sclerosis

This study is testing if a supplement called N-acetyl cysteine can help protect nerves and slow down the progression of multiple sclerosis in adults aged 40 to 70.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 40 Years to 70 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT05122559 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of N-acetyl cysteine (NAC) in treating patients with progressive forms of multiple sclerosis. Participants will be randomly assigned to receive either NAC or a placebo to assess its neuroprotective effects. The study aims to determine if NAC can slow disease progression and improve clinical outcomes in this patient population. It includes patients aged 40-70 who meet specific diagnostic criteria and have experienced clinical changes in their condition over the past two years.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-70 with primary or secondary progressive multiple sclerosis who have shown clinical changes over the past two years.

Not a fit: Patients who have experienced relapses in the past six months or are currently on oral glucocorticosteroids may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could slow the progression of multiple sclerosis and improve quality of life for patients.

How similar studies have performed: While there is ongoing research into neuroprotective strategies for multiple sclerosis, the specific use of N-acetyl cysteine in this context is relatively novel.

Eligibility criteria

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 surgery or move within 15 months
* use of medications/supplements with antioxidant properties (including over-the-counter NAC)

Where this trial is running

San Francisco, California

• University of California, San Francisco — San Francisco, California, United States (Recruiting)

Study contacts

• Study coordinator: Uk Sok Shin, BA

Conditions Multiple Sclerosis; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Secondary Progressive