Primary Progressive Multiple Sclerosis
Conditions
Brief summary
6-month composite Confirmed Disability Progression (cCDP)
Detailed description
6-month Confirmed Disability Progression (CDP), 3-month composite Confirmed Disability Progression (cCDP), Change in T2 hyperintense lesions by MRI, Time to onset of confirmed disability improvement (CDI), Percent change in Brain volume (BV), Change in cognitive function as assessed by SDMT, Change in cognitive function as assessed by CVLT-II, Change in Multiple Sclerosis Quality of Life, Safety and Tolerability, Population pharmacokinetics, Change in plasma neurofilament light chain (NfL), Change in lymphocyte phenotype subsets, Changes in serum Immunoglobulin level, Change in serum chitinase-3 like protein 1 (Chi3L1)
Interventions
DRUGmannitol and microcrystalline cellulose
DRUGTolebrutinib
Sponsors
Genzyme Corp.
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month composite Confirmed Disability Progression (cCDP) | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month Confirmed Disability Progression (CDP), 3-month composite Confirmed Disability Progression (cCDP), Change in T2 hyperintense lesions by MRI, Time to onset of confirmed disability improvement (CDI), Percent change in Brain volume (BV), Change in cognitive function as assessed by SDMT, Change in cognitive function as assessed by CVLT-II, Change in Multiple Sclerosis Quality of Life, Safety and Tolerability, Population pharmacokinetics, Change in plasma neurofilament light chain (NfL), Change in lymphocyte phenotype subsets, Changes in serum Immunoglobulin level, Change in serum chitinase-3 like protein 1 (Chi3L1) | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden
Outcome results
None listed