NCT01080014

Correlation Between Multiple Sclerosis Functional Composite (MSFC) and Expanded Disability Status Scale (EDSS) in Patients With Multiple Sclerosis (MS) in Argentina

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 252 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Multiple Sclerosis

Timeline

• Start date: 2008-08-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-03-03
• Last updated: 2013-10-16

Locations

1 site across 1 country: Argentina