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

NCT01080014 | Completed

• 1 other identifier: EMR 200077_502
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• - 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

Secondary Outcomes (1)

• To evaluate the predictive validity of MSFC score of a subsequent EDSS change in a subgroup of MS patients

  Baseline, 1 year, 2 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with MS in 20 sites across Argentina

You may qualify 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 qualify 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Dr. Roberto Rosa

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Roberto Rosa, PhD

  PhD Neurologist, Unaffiliated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: March 3, 2010
• Study Start: August 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

AR (1)