Multiple Sclerosis, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive
Conditions
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.
Interventions
DRUGN-acetyl cysteine
N-acetyl cysteine (NAC) is a Glutathione (GSH) precursor with antioxidant properties which make it relevant for neuroprotection.
DRUGPlacebo
Lactose Monohydrate, USP (100%), magnesium stearate, silicon dioxide NF
Sponsors
Emmanuelle Waubant, MD PhD
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
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 * allergy to NAC * planned surgery or move within 15 months * use of medications/supplements with antioxidant properties (including over-the-counter NAC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical effects of NAC | 15 months | Clinical effects in MS as measured by the 9-HPT, 25-foot walk, symbol digit modalities test (SDMT). |
Countries
United States
Outcome results
None listed