We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01080014
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):
Merck KGaA

Brief 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.

Condition or disease
Multiple Sclerosis

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.


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

Study Type : Observational
Actual Enrollment : 252 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : August 2008
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. - Evaluation of correlations between changes over time [ Time Frame: Baseline and two years ]
    - 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

Secondary Outcome Measures :
  1. To evaluate the predictive validity of MSFC score of a subsequent EDSS change in a subgroup of MS patients [ Time Frame: Baseline, 1 year, 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with MS in 20 sites across Argentina

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080014

Dr. Roberto Rosa
Buenos Aires, Argentina
Sponsors and Collaborators
Merck KGaA
Principal Investigator: Dr. Roberto Rosa, PhD PhD Neurologist, Unaffiliated

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01080014     History of Changes
Other Study ID Numbers: EMR 200077_502
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

Keywords provided by Merck KGaA:
Relapsing-remitting multiple sclerosis (RRMS)
primary progressive multiple sclerosis (PPMS)
secondary progressive multiple sclerosis (SPMS)
Multiple Sclerosis Functional Composite (MSFC)
Expanded Disability Status Scale (EDSS)

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases