Correlation Between Multiple Sclerosis Functional Composite (MSFC) and Expanded Disability Status Scale (EDSS) in Patients With Multiple Sclerosis (MS) in Argentina
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Lead
Merck KGaA, Darmstadt, Germany
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
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects with definite diagnosis of MS, according to McDonald's criteria
All clinical types: relapsing-remitting MS (RRMS), primary progressive MS (PPMS) and secondary progressive MS (SPMS). Stable disease course without any relapse for at least the previous 3 months
Subjects treated or not with disease modifying drugs
Ages between 18 and 65 years and is capable of understanding and complying with protocol requirements
Subject has a stable residence with no planned move during the entire investigation period
You may not be if
Life expectancy less than 5 years at admission
Diagnosis of clinically isolated syndrome (CIS)
Other clinical conditions that mimic MS
Psychiatric diseases
Alcohol or drug abuse
Pregnancy
The subject is unwilling or unable to comply with the protocol or scheduled appointments
Subject is unable to understand the language in which the approved informed consent is written
The subject is a study site employee, or an immediate family member (i.e., spouse, parent, child, sibling) of a study site employee, involved in conduct of this study
Clareo Health | Correlation Between Multiple Sclerosis Functional Composite (MSFC) and Expanded Disability Status Scale (EDSS) in Patients With Multiple Sclerosis (MS) in Argentina
