Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis

Launched by EMMANUELLE WAUBANT, MD PHD · Nov 8, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called N-acetyl cysteine (NAC) can help protect the nerves in patients with progressive forms of multiple sclerosis (MS). The study will involve two groups of participants: one group will receive NAC, while the other will receive a placebo, which is a harmless substitute that does not contain the active medication. The goal is to see if NAC can slow down the progression of symptoms in people with primary or secondary progressive MS.

To be eligible for this trial, participants must be between the ages of 40 and 70 and have been diagnosed with progressive MS for at least two years. They should have experienced clinical changes in their symptoms over the past two years, such as difficulty walking or changes in cognitive abilities. Participants will need to be stable on their current MS treatment for at least three months before the study begins. Throughout the trial, participants will undergo regular assessments to monitor their health and the effectiveness of the treatment. This study is currently recruiting, and it’s an opportunity for eligible patients to potentially benefit from a new approach to managing their condition.

Gender

ALL

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)