RIS (Radiologically Isolated Syndrome)
Conditions
Brief summary
The primary endpoint of the study will be the cumulative number of CUAL on MRI scans over 1 year.
Detailed description
Time to first clinical event within the 3-year period., Exploraty endpoints: - Number of cortical lesions - Percentage of Brain Volume Changes (PBVC) - Changes in volume of cortex and White matter - Magnetization transfer ratio (MTr) in lesions - MTr in normal-looking brain, Safety / tolerability endpoints: Adverse events occurring during the study and laboratory tests
Interventions
DRUGSodio cloruro S.A.L.F. 0
DRUG9% solvente per uso parenterale.
DRUGBCG 10 Anti-Tuberculosis Vaccine
DRUGPowder and solvent for suspension for intradermal injection Vaccinum tuberculosis (BCG) cryodesiccatum
Sponsors
Fondazione Italiana Sclerosi Multipla Ente Del Terzo Settore/et S
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study will be the cumulative number of CUAL on MRI scans over 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first clinical event within the 3-year period., Exploraty endpoints: - Number of cortical lesions - Percentage of Brain Volume Changes (PBVC) - Changes in volume of cortex and White matter - Magnetization transfer ratio (MTr) in lesions - MTr in normal-looking brain, Safety / tolerability endpoints: Adverse events occurring during the study and laboratory tests | — |
Countries
Italy
Outcome results
None listed