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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02575365
Study type Interventional
Source Novartis
Contact
Status Terminated
Phase Phase 4
Start date February 16, 2016
Completion date January 27, 2017

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