Multiple sclerosis secondary progressive form
Conditions
Brief summary
Percent brain volume change from last cladribine dose (week 26) to end of study (week 122).
Detailed description
1.Time to 24-week confirmed composite progression of disability defined as the occurrence of any of the following events: an increase in EDSS score, in time of Timed 25-Foot Walk and 9-Hole Peg Test. 2.Change from baseline in cognitive function (CANTAB, CVLT, SDMT) and quality of life (MSQeL-54) 3.Neuroimaging: number of Gd+ lesions, new T2 lesions, QSM rim+ lesions, volume of T1 lesions (black holes), volume of cervical spinal cord in T1; 4. Serum level of NfL, GFAP, oligoclonal bands presence
Interventions
Sponsors
Instytut Psychiatrii I Neurologii
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent brain volume change from last cladribine dose (week 26) to end of study (week 122). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Time to 24-week confirmed composite progression of disability defined as the occurrence of any of the following events: an increase in EDSS score, in time of Timed 25-Foot Walk and 9-Hole Peg Test. 2.Change from baseline in cognitive function (CANTAB, CVLT, SDMT) and quality of life (MSQeL-54) 3.Neuroimaging: number of Gd+ lesions, new T2 lesions, QSM rim+ lesions, volume of T1 lesions (black holes), volume of cervical spinal cord in T1; 4. Serum level of NfL, GFAP, oligoclonal bands presence | — |
Countries
Poland
Outcome results
None listed