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OpenTrials
Active, Not Recruiting

NCT Number: NCT05122559

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

N-acetyl cysteine

Drug

N-acetyl cysteine (NAC) is a Glutathione (GSH) precursor with antioxidant properties which make it relevant for neuroprotection.

Other names: NAC

Placebo

Drug

Lactose Monohydrate, USP (100%), magnesium stearate, silicon dioxide NF

Primary outcomes

  1. Safety and tolerability

    Time frame: 15 months

    Number of adverse events recorded by system, severity, and by relationship to treatment arm.

  2. Effect of NAC on on progression of brain, thalamic and cervical cord atrophy

    Time frame: 15 months

    The primary endpoint is brain, thalamic and cord atrophy measured by brain and cervical spine MRI at month 3 and month 15.

Secondary outcomes

  1. Clinical effects of NAC

    Time frame: 15 months

    Clinical effects in MS as measured by the 9-HPT, 25-foot walk, symbol digit modalities test (SDMT).

Other outcomes

  1. Effect of NAC on progression of MS

    Time frame: 15 months

    Monitoring progression using imaging metrics and changes captured by a wearable multi-sensor device.

Sponsors and collaborators

Lead sponsor

Emmanuelle Waubant, MD PhD

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Acronym: NACPMS

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Nov 16, 2021
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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