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

Multiple Sclerosis Clinical Trial

— NACPMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05122559
• Other study ID #: P0549747
• Status: Recruiting
• Phase: Phase 2
• Start date: February 16, 2022
• Est. completion date: February 2025

Study information

• Verified date: March 2023
• Source: University of California, San Francisco
• Contact: Uk Sok Shin, BA
• Phone: (415) 321-9373
• Email: uksok.shin[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Primary Progressive
• Multiple Sclerosis, Secondary Progressive
• Sclerosis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Emmanuelle Waubant, MD PhD	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of NAC on progression of MS	Monitoring progression using imaging metrics and changes captured by a wearable multi-sensor device.	15 months
Primary	Safety and tolerability	Number of adverse events recorded by system, severity, and by relationship to treatment arm.	15 months
Primary	Effect of NAC on on progression of brain, thalamic and cervical cord atrophy	The primary endpoint is brain, thalamic and cord atrophy measured by brain and cervical spine MRI at month 3 and month 15.	15 months
Secondary	Clinical effects of NAC	Clinical effects in MS as measured by the 9-HPT, 25-foot walk, symbol digit modalities test (SDMT).	15 months