TerminatedPhase 2/3

Study to Assess the Efficacy of Mayzent on Microglia in Secondary Progressive Multiple Sclerosis

Stopped: Lack of recruitment

United States8 participantsStarted 2021-11-13

Plain-language summary

To assess the efficacy of Mayzent on microglia pathology in patients with active SPMS, as compared to the active control group of MS patients treated with the Ocrevus, as measured by changes in microglial activation in the lesional and non-lesional NAWM and NAGM and in the peri-plaque area of chronic lesions in the brain.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients diagnosed with active SPMS according to the Lublin 2014 criteria. Activity is determined by MRI activity (contrast-enhancing lesions; new and unequivocally enlarging T2 lesions) and/or clinical relapses in the 24 months prior to the study baseline. If the clinical MRI is not available to determine the activity (contrast-enhancing lesions; new and unequivocally enlarging T2 lesions), then a screening MRI will be offered to the subjects to determine inclusion/exclusion criteria eligibility. * Age between 18 and 60 years * Have EDSS scores between 3.0 and 6.5 * Treatment naïve to both Mayzent and to Ocrevus * Not being on S1P modulators or B-cell therapies for the last 9 months * Subjects starting treatment as part of their clinical routine * Be willing and able to comply with the study procedures for the duration of the trial * Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) authorization before any study-related activities are carried out * Normal kidney functioning (creatinine clearance \>59) * No known hypersensitivity reactions to contrast agents * None of the exclusion criteria Exclusion Criteria: * Have received treatment within 30 days prior to enrollment with steroids or any other concomitant immunomodulatory therapies * Have received an investigational drug or experimental procedure within the past 30 days * Low affinity (LAB) for the DNA single nucleotide polymorphism (SNP) of…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in PET Activation at 12 Months

Timeframe: 12 months

Trial details

NCT IDNCT04925557

SponsorState University of New York at Buffalo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-01

Results submitted2025-01-02

View on ClinicalTrials.gov More Secondary-progressive Multiple Sclerosis trials