NCT02575365

Effect of Fingolimod on Neurodegeneration

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cognition
• Brain Volume Loss

Interventions

Type	Name	Description
DRUG	0,5 mg Fingolimod	0.5 mg p.o fingolimod daily

Timeline

• Start date: 2016-02-16
• Primary completion: 2017-01-27
• Completion: 2017-01-27
• First posted: 2015-10-14
• Last updated: 2019-02-27
• Results posted: 2019-02-27

Locations

3 sites across 1 country: Turkey (Türkiye)