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Clinical Trials/NCT05122559
NCT05122559
Active, not recruiting
Phase 2

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

Emmanuelle Waubant, MD PhD1 site in 1 country98 target enrollmentStarted: February 16, 2022Last updated:
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ConditionsMultiple SclerosisMultiple Sclerosis, Primary ProgressiveMultiple Sclerosis, Secondary Progressive
InterventionsN-acetyl cysteinePlacebo
DrugsN-acetyl cysteinePlacebo

Overview

Phase
Phase 2
Status
Active, not recruiting
Sponsor
Emmanuelle Waubant, MD PhD
Enrollment
98
Locations
1
Primary Endpoint
Safety and tolerability
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

N-acetyl cysteine

Active Comparator

N-acetyl cysteine (NAC) 1200mg t.i.d.

Intervention: N-acetyl cysteine (Drug)

Placebo

Placebo Comparator

Placebo 1200mg t.i.d.

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Safety and tolerability

Time Frame: 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

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 Outcomes

  • Clinical effects of NAC(15 months)

Investigators

Sponsor
Emmanuelle Waubant, MD PhD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Emmanuelle Waubant, MD PhD

Professor, Neurology UCSF Weill Institute for Neurosciences

University of California, San Francisco

Study Sites (1)

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