This was a 24-month, open-label, multicenter study with a single treatment arm design.
Primary objective of this study was:
-To investigate the effects of Fingolimod on cognitive performance in highly active relapsing
remitting multiple sclerosis patients
Secondary objectives of this study were:
- To investigate the correlation between the effect of fingolimod on cognitive
performances and MRI data.
- To evaluate the effect of fingolimod on biomarkers (24 hydroxy cholesterol, osteopontin
and matrix metalloproteinases) related to neurodegeneration
- To investigate the effect of fingolimod on brain gray matter atrophy and thalamic
atrophy.
Polulation The hope was to recruit a minimum of 80 relapsing remitting MS (RRMS) patients
according to the McDonald criteria.