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

Phase 2

Recruiting

• Conditions: Multiple Sclerosis; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Secondary Progressive
• Interventions: Drug: N-acetyl cysteine; Drug: Placebo

• Registration Number: NCT05122559
• Lead Sponsor: Emmanuelle Waubant, MD PhD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-08
• Study First Posted: 2021-11-16
• Study Start: 2022-02-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-acetyl cysteine	N-acetyl cysteine	N-acetyl cysteine (NAC) 1200mg t.i.d.
Placebo	Placebo	Placebo 1200mg t.i.d.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	15 months	Number of adverse events recorded by system, severity, and by relationship to treatment arm.
Effect of NAC on on progression of brain, thalamic and cervical cord atrophy	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

Name	Time	Method
Clinical effects of NAC	15 months	Clinical effects in MS as measured by the 9-HPT, 25-foot walk, symbol digit modalities test (SDMT).

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States