drugset / Trial / NCT02575365

Effect of Fingolimod on Neurodegeneration

NCT02575365

Phase 4 Terminated 4 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2016-02-16
Primary completion
2017-01-27
Completion
2017-01-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Fingolimod Small molecule 0.5 mg Oral

Indications

No indication recorded.