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.


Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome:

  • Change from baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery test at 12 months [ Time Frame: baseline , month 12 ]
    The Brief International Cognitive Assessment for MS (BICAMS Battery) includes 3 cognitive tests, 1-Symbol Digit Modalities Test (SDMT, 2-the second edition of the California Verbal Learning Test (CVLT2) and 3-the revised Brief Visuospatial Memory Test (BVMTR).
  • Change from baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery test at 24 months [ Time Frame: baseline and month 24 ]
    The Brief International Cognitive Assessment for MS (BICAMS Battery) includes 3 cognitive tests, 1-Symbol Digit Modalities Test (SDMT, 2-the second edition of the California Verbal Learning Test (CVLT2) and 3-the revised Brief Visuospatial Memory Test (BVMTR).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in PASAT Test [ Time Frame: baseline ,months 6, month 12 and month 24 ]
    The Paced Auditory Serial Addition Test (PASAT) has been widely used in MS trials and it is considered to be a measure of sustained attention, divided attention, concentration, and information processing speed.
  • Change from baseline in Stroop Test [ Time Frame: baseline, month 6, month 12 and month 24 ]
    The Stroop Color and Word Test assesses cognitive processing and provides valuable diagnostic information on brain dysfunction, cognition, and psychopathology
  • Change from baseline in brain gray matter atrophy and thalamic atrophy [ Time Frame: baseline, month 6, month 12, month 18 and month 24 ]
    MRI scans will be obtained by using 1,5T MRI for measuring gray matter atrophy and thalamic atrophy and a standard scanning protocol will be used for MRI in all centers.
  • Change from baseline in serum levels of 24S-hydroxycholesterol (24OHC) , osteopontin and matrix metalloproteinases (and also MMPI's) [ Time Frame: baseline, month 6, month , month 12 and month 24 ]
    Serum samples will be collected at baseline and at months 6, 12 and 24 from each participant after evaluation for inclusion and exclusion criteria for measurement of 24 hydroxy cholesterol, osteopontin and matrix metalloproteinases (including MMPI's).
  • the correlation between effect of fingolimod on cognitive performances and brain atrophy (gray matter atrophy and thalamic atrophy) by comparing baseline and month 24. [ Time Frame: baseline, month 24 ]
    Correlation between effect of fingolimod on cognitive performances based on cognitive tests and brain atrophy based on MRI assessments will be explored.


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: October 12, 2015
Date Started: February 2016
Date Completion: October 2018
Last Updated: November 11, 2016
Last Verified: November 2016