At a glance
ClinicalIndex Comparison Record- ✓Age 18–75 years
- ✓Diagnosis of primary or secondary progressive multiple sclerosis per 2010 McDonald criteria
- ✓MS symptom onset >1 year prior
- ✓EDSS score 2.0–6.5 at screening
- ✕MS relapse within 3 months prior to screening
- ✕Receiving or starting interferon beta or immunosuppressive medications (cyclophosphamide, mitoxantrone, methotrexate, mycophenolate mofetil)
- ✕Starting or changing dose of other MS disease-modifying medications (including monoclonal antibodies) within 3 months of baseline
- ✕No ongoing steroid use and none in prior month
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Randomized, Placebo- Controlled, Parallel Group, Double Blinded Single Center Study on Effect of N-acetyl Cysteine Compared to Placebo on Fatigue in Patients With Progressive Multiple Sclerosis
In Brief
A Phase 2 clinical trial evaluating N-acetyl cysteine and Placebo for Progressive Multiple Sclerosis and Fatigue. Completed, enrolled 15 participants across 1 site.
Detailed Summary
This is a 4-week randomized, placebo-controlled, parallel group, double-blind, single center trial on effect of N-acetyl cysteine versus placebo on fatigue in patients with progressive MS defined by McDonald criteria. Subjects who enter the treatment phase of study, will be randomly assigned to either N-acetyl cysteine (1250 mg three times a day) or placebo (three times a day) for 4 weeks. There will be 3 in-person study visits (screening, baseline, and week 4) and 2 visits over the phone (week 2, and week 6 which is 2 weeks after completing last study drug dose). Visits will all occur in the morning to maximize consistency of assessments and evaluate main outcomes within 2 hours of morning dose of study medication. Fatigue questionnaires, and research samples will be obtained before neurological examination, or magnetic resonance imaging. Research blood draws will be obtained just after fatigue questionnaire completion. Brain spectroscopy will be obtained less than 2 hours after morning dose of study drug to maximize detection of the biological effect of study medication.
Study Details
Timeline
Interventions
1250 mg of N- acetyl cysteine taken three times daily
placebo taken three times daily