Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis
NCT ID: NCT05122559
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
98 participants
INTERVENTIONAL
2022-02-16
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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N-acetyl cysteine
N-acetyl cysteine (NAC) 1200mg t.i.d.
N-acetyl cysteine
N-acetyl cysteine (NAC) is a Glutathione (GSH) precursor with antioxidant properties which make it relevant for neuroprotection.
Placebo
Placebo 1200mg t.i.d.
Placebo
Lactose Monohydrate, USP (100%), magnesium stearate, silicon dioxide NF
Interventions
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N-acetyl cysteine
N-acetyl cysteine (NAC) is a Glutathione (GSH) precursor with antioxidant properties which make it relevant for neuroprotection.
Placebo
Lactose Monohydrate, USP (100%), magnesium stearate, silicon dioxide NF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
40 Years
70 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Emmanuelle Waubant, MD PhD
OTHER
Responsible Party
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Emmanuelle Waubant, MD PhD
Professor, Neurology UCSF Weill Institute for Neurosciences
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Schoeps VA, Graves JS, Stern WA, Zhang L, Nourbakhsh B, Mowry EM, Henry RG, Waubant E. N-Acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple Sclerosis (NACPMS) trial: Study protocol for a randomized, double-blind, placebo-controlled add-on phase 2 trial. Contemp Clin Trials. 2022 Nov;122:106941. doi: 10.1016/j.cct.2022.106941. Epub 2022 Sep 28.
Other Identifiers
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P0549747
Identifier Type: -
Identifier Source: org_study_id
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