Trial Outcomes & Findings for Study to Assess the Efficacy of Mayzent on Microglia in Secondary Progressive Multiple Sclerosis (NCT NCT04925557)

NCT ID: NCT04925557

Last Updated: 2025-05-13

Results Overview

Change from baseline in PET activation of PBR06 in lesional and non-lesional NAWM and NAGM in the brain of the patients under treatment with Mayzent when 100% of patients reach 12 months;

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

8 participants

Primary outcome timeframe

12 months

Results posted on

2025-05-13

Participant Flow

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. Patients were recruited from 2 medical clinics.

Participant milestones

Participant milestones
Measure	Ocrevus Patients diagnosed with secondary-progressive multiple sclerosis who have been prescribed Ocrevus by their neurologist. Ocrevus: PET imaging to evaluate the effects of Ocrevus on the microglia of the brain.	Mayzent Patients diagnosed with secondary-progressive multiple sclerosis who have been prescribed Mayzent by their neurologist. Mayzent: PET imaging to evaluate the effects of Mayzent on the microglia of the brain.
Overall Study STARTED	5	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Ocrevus Patients diagnosed with secondary-progressive multiple sclerosis who have been prescribed Ocrevus by their neurologist. Ocrevus: PET imaging to evaluate the effects of Ocrevus on the microglia of the brain.	Mayzent Patients diagnosed with secondary-progressive multiple sclerosis who have been prescribed Mayzent by their neurologist. Mayzent: PET imaging to evaluate the effects of Mayzent on the microglia of the brain.
Overall Study Study closed	5	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ocrevus n=5 Participants Patients diagnosed with secondary-progressive multiple sclerosis who have been prescribed Ocrevus by their neurologist. Ocrevus: PET imaging to evaluate the effects of Ocrevus on the microglia of the brain.	Mayzent n=3 Participants Patients diagnosed with secondary-progressive multiple sclerosis who have been prescribed Mayzent by their neurologist. Mayzent: PET imaging to evaluate the effects of Mayzent on the microglia of the brain.	Total n=8 Participants Total of all reporting groups
Age, Continuous	51 years n=5 Participants	53 years n=3 Participants	52 years n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=3 Participants	3 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=3 Participants	5 Participants n=8 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 12 months

Population: Study was terminated. No subject had any further data collected after the initial visit.

Change from baseline in PET activation of PBR06 in lesional and non-lesional NAWM and NAGM in the brain of the patients under treatment with Mayzent when 100% of patients reach 12 months;

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6, 12, 24 and 36 months

Population: Study was terminated. No subject had any further data collected after the initial visit.

Change from baseline in PET activation of PBR06 in lesional and non-lesional NAWM and NAGM in the brain of the patients treated with Mayzent and active control group at 6, 12, 24 and 36 months from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6, 12, 24 and 36 months

Population: Study was terminated. No subject had any further data collected after the initial visit.

The cumulative number of new ultrasmall superparamagnetic iron oxide (USPIO) particles contrast enhancing (CE) active lesions on T1-weighted images between Mayzent and active control group, as measured at 6, 12, 24 and 36 months from baseline.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12, 24 and 36 months

Population: Study was terminated. No subject had any further data collected after the initial visit.

Percent brain volume change (PBVC) between baseline and 12, 24, and 36 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12, 24 and 36 months

Population: Study was terminated. No subject had any further data collected after the initial visit.

Percent cortical volume change (PCVC), between baseline and 12, 24, and 36 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12, 24 and 36 months

Population: Study was terminated. No subject had any further data collected after the initial visit.

Percent thalamus volume change (PTVC) between baseline and 12, 24, and 36 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12, 24 and 36 months

Population: Study was terminated. No subject had any further data collected after the initial visit.

Quantitative susceptibility mapp (QSM) change between baseline and 12, 24, and 36 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6, 12, 24 and 36 months

Population: Study was terminated. No subject had any further data collected after the initial visit.

The cumulative number of new gadolinium CE lesions on T1-weighted images at months 6, 12, 24 and 36 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6, 12, 24 and 36 months

Population: Study was terminated. No subject had any further data collected after the initial visit.

The cumulative number of new or newly enlarging hyperintense T2 lesions measured at months 6, 12, 24 and 36 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6, 12, 24 and 36 months

Population: Study was terminated. No subject had any further data collected after the initial visit.

The absolute change in hyperintense T2-lesion volume (LV) measured at months 6, 12, 24 and 36 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6, 12, 24 and 36 months

Population: Study was terminated. No subject had any further data collected after the initial visit.

The absolute change in hypo-intense T1-lesion volume (LV) measured at months 6, 12, 24 and 36 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6, 12, 24 and 36 months

Population: Study was terminated. No subject had any further data collected after the initial visit.

The absolute change in serum neurofilament light chain (sNfL) and glial fibrillary acidic protein (GFAP) at 6, 12, 24 and 36 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 and 36 months

Population: Study was terminated. No subject had any further data collected after the initial visit.

The association between imaging and clinical and cognitive outcomes, incl. the composite EDSS+SDMT, over 24 and 36 months of the study

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12, 24, and 36 months

Population: Study was terminated. No subject had any further data collected after the initial visit.

Safety of Mayzent and active control group over 12, 24, and 36 months of the study

Outcome measures

Outcome data not reported

Adverse Events

Ocrevus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mayzent

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ocrevus n=5 participants at risk Patients diagnosed with secondary-progressive multiple sclerosis who have been prescribed Ocrevus by their neurologist. Ocrevus: PET imaging to evaluate the effects of Ocrevus on the microglia of the brain.	Mayzent n=3 participants at risk Patients diagnosed with secondary-progressive multiple sclerosis who have been prescribed Mayzent by their neurologist. Mayzent: PET imaging to evaluate the effects of Mayzent on the microglia of the brain.
Injury, poisoning and procedural complications Allergic Reaction	0.00% 0/5 • Baseline to 5 months. Case form provided by the study sponsor.	66.7% 2/3 • Number of events 2 • Baseline to 5 months. Case form provided by the study sponsor.

Additional Information

Dr. Robert Zivadinov

State University of New York at Buffalo

Phone: 716-248-2140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60