A Observational, Prospective Study to Assess the Impact of Fatigue in the Quality of Life of Patients With Multiple Sclerosis in Argentina

March 6, 2014 updated by: Merck KGaA, Darmstadt, Germany

Impact of Fatigue in the Quality of Life of Patients With Multiple Sclerosis in Argentina

This is an observational, non-controlled, multicentric, prospective study planned to be conducted in 66 subjects diagnosed with multiple sclerosis (MS) in 20 centres of Argentina. Fatigue is recognized as one of the most frequent symptoms of MS with a high incidence in MS subjects. The link between fatigue and the degree of disability and other manifestations of the disease, such as depression has not been yet clearly understood. Hence, this study aims to understand the way in which fatigue impairs the quality of life (QoL) of MS subjects. This epidemiologic study can contribute to a better understanding of the way in which fatigue correlates with depression and the intensity with which both situations impact on the QoL of MS subjects.

Study Overview

Status

Completed

Conditions

Detailed Description

Fatigue is recognized as one of the most frequent symptoms of MS and its impact on QoL of subjects is high. Fatigue in MS is sometimes considered as a prodromic symptom or as a peculiar symptom that must be differentiated from natural fatigue, pathological fatigue of other chronic diseases; as well as from fatigue caused by the excessive effort in case of gait disorder, spasticity or paresis. The origin of the fatigue symptom in MS is unknown and the cause is likely to be multifactorial. The evaluation of the fatigue is challenging, due to its variability and hence, scales such as Krupp's Fatigue Severity Scale (FSS) has been developed for measuring MS fatigue.

OBJECTIVES

Primary objective:

  • To determine the impact of fatigue on QoL of MS subjects in Argentina

Secondary objective:

  • To evaluate correlation between FSS and disability, depression, demographic variables; and between FSS and the use of disease modifying drugs
  • To determine the impact of depression and neurological disability on QoL of MS subjects in Argentina

The subjects will be managed with the clinical and therapeutic elements that the treating doctor considers appropriate, without modifying their decisions due to the subject inclusion into the study. The epidemiologic data required by this study will be collected by the investigator from the documents in which each subject visit is registered, whether programmed or not. Once the recruiting period of 12 months is over, the collection of data will continue during the full 24 months period for each subject. The closure of the study will be marked by the follow-up of the last subject who entered the study.

Study Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Capital federal, Buenos Aires, Argentina
        • Hospital Fernandez de Buenos Aires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects diagnosed with MS in Argentina.

Description

Inclusion Criteria:

  • Subjects with MS diagnosis (McDonald's criteria) in its relapsing remitting form
  • Subjects between 21-60 years of age
  • Subjects who did not have relapses during the 3 months before the inclusion
  • Subjects with more than 1 year since the MS diagnosis or with a clinically defined MS

Exclusion Criteria:

  • Subjects with life expectancy of less than 5 years at the moment of inclusion
  • Subjects with other associated neurological disease
  • Subjects with psychiatric diseases
  • Subjects who have familiar antecedents (first grade) of severe depression
  • Subjects with alcohol or drug abuse
  • Subjects who are pregnant
  • Subjects with FSS between 4 and 5
  • Subjects who have used anxiolytics and anti depressants that could affect the fatigue symptoms during the 3 months before the inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Multiple Sclerosis International Quality of Life (MusiQoL) in multiple sclerosis fatigue (MSF) [Fatigue Severity Scale (FSS) >5] versus multiple sclerosis nonfatigue (MSNF) (FSS <4) subjects
Time Frame: Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month)
Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic characteristics
Time Frame: Initial visit (Day 0)
Demographic and baseline variables include age, gender, race, baseline disease severity, sleep history, and baseline sleep assessments.
Initial visit (Day 0)
Duration of the disease
Time Frame: Initial visit (Day 0)
Identifying the number of years since disease onset.
Initial visit (Day 0)
Treatment or treatment changes
Time Frame: Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month)
identifying the agents used for the treatment and the treatment duration.
Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month)
Expanded Disability Status Scale (EDSS)
Time Frame: Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month)
EDSS >=3,5 disability and EDSS <=3,5 no disability
Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month)
Hamilton Depression Inventory-17 (HDI-17)
Time Frame: Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month)
Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month)
Fatigue Severity Scale (FSS)
Time Frame: Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month)
Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Investigators

  • Principal Investigator: Dr. Norma Aydeé Deri, Hospital Fernandez, Buenos Aires, Argentina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (Estimate)

March 3, 2010

Study Record Updates

Last Update Posted (Estimate)

March 7, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR 200077-506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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