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Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis (NACPMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05122559
Recruitment Status : Recruiting
First Posted : November 16, 2021
Last Update Posted : April 4, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Emmanuelle Waubant, MD PhD, University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Secondary Progressive Drug: N-acetyl cysteine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of N-acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple Sclerosis
Actual Study Start Date : February 16, 2022
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2025


Arm Intervention/treatment
Active Comparator: N-acetyl cysteine
N-acetyl cysteine (NAC) 1200mg t.i.d.
Drug: N-acetyl cysteine
N-acetyl cysteine (NAC) is a Glutathione (GSH) precursor with antioxidant properties which make it relevant for neuroprotection.
Other Name: NAC

Placebo Comparator: Placebo
Placebo 1200mg t.i.d.
Drug: Placebo
Lactose Monohydrate, USP (100%), magnesium stearate, silicon dioxide NF




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05122559


Contacts
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Contact: Uk Sok Shin, BA (415) 321-9373 uksok.shin@ucsf.edu
Contact: Emmanuelle Waubant, MD, PhD 415-514-8199 emmanuelle.waubant@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Uk Sok Shin, B.A.    415-321-9373    uksok.shin@ucsf.edu   
Contact: Alina Dobai, M.D.    415-476-4882    AlinaLoredana.Dobai@ucsf.edu   
Sponsors and Collaborators
Emmanuelle Waubant, MD PhD
United States Department of Defense
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emmanuelle Waubant, MD PhD, Professor, Neurology UCSF Weill Institute for Neurosciences, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05122559    
Other Study ID Numbers: P0549747
First Posted: November 16, 2021    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes