RECRUITING

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

Conditions

Multiple Sclerosis Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Secondary Progressive

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-16

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05122559

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* - 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)

Inclusion Criteria

Exclusion 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.

* - 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)

Contacts and Locations

Study Contact

Uk Sok Shin, BA

CONTACT

(415) 321-9373

uksok.shin@ucsf.edu

Emmanuelle Waubant, MD, PhD

CONTACT

415-514-8199

emmanuelle.waubant@ucsf.edu

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94158

United States

Collaborators and Investigators

Sponsor: Emmanuelle Waubant, MD PhD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-16

Study Completion Date2026-02

Study Record Updates

Study Start Date2022-02-16

Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

Multiple Sclerosis
Multiple Sclerosis, Primary Progressive
Multiple Sclerosis, Secondary Progressive