Multiple Sclerosis Clinical Trial
Official title:
The Multiple Sclerosis Functional Composite (MSFC) in the Follow-up of MS Patients: Correlation With the Expanded Disability Status Scale (EDSS) Among Different Clinical Forms in Argentina
This observational study is being conducted to evaluate the usefulness of the MSFC and its relationship with EDSS scores in subjects with MS in Argentina.
This observational, open-label study is being conducted to correlate change in EDSS score
with the change in MSFC scores at the end of a 2-year follow-up period for subjects with MS
in Argentina. Measurement of disability is an indispensable parameter in assessing the
efficacy of experimental therapeutic agents in MS as well as in trying to determine possible
individual evolution of the disease. Clinical scales are being used as primary or secondary
outcome measures for recording disease progression in clinical trials. Kurtzke's EDSS is
still used as a gold standard for measuring impairment and disability in MS. The MSFC is an
examination-based quantitative scoring of neurological impairment. This study aims to
establish a correlation between the usefulness of both scales.
OBJECTIVES
Primary Objective:
- To evaluate the change in MSFC score with change in EDSS scores at end of 2 year
follow-up period for subjects with MS in Argentina
Secondary Objectives:
- To evaluate the cross-sectional correlations in MSFC score at baseline and at 24 months
with EDSS score at baseline and at 24 months
- To describe the MSFC score for MS phenotype in this population
- To evaluate the predictive validity of MSFC score of a subsequent EDSS change in a
subgroup of MS patients in Argentina
;
Observational Model: Cohort, Time Perspective: Prospective
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