Clinical Trial: Effect of Fingolimod on Neurodegeneration

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional



Official Title: Effect of Fingolimod on Neurodegeneration, Brain Atrophy and Cognitive Impairment in Relapsing Remitting Multiple Sclerosis Patients

Brief Summary:

This is a 24-month, open-label, multicenter study with a single treatment arm design.

Primary objective of this study is:

-To investigate the effects of Fingolimod on cognitive performance in highly active relapsing remitting multiple sclerosis patients

Secondary objectives of this study are:

  • 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 We will recruit a minimum of 80 relapsing remitting MS (RRMS) patients according to the McDonald criteria.