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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080014
• Other study ID #: EMR 200077_502
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: October 13, 2013
• Start date: August 2008
• Est. completion date: April 2013

Study information

• Verified date: October 2013
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Argentina	Dr. Roberto Rosa	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Evaluation of correlations between changes over time	- Evaluation of correlations between changes over time for MSFC composite score and arm, leg and cognitive MSFC scores versus EDSS score changes over the same periods	Baseline and two years	No
Secondary	To evaluate the predictive validity of MSFC score of a subsequent EDSS change in a subgroup of MS patients		Baseline, 1 year, 2 years	No