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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01080001
First received: March 2, 2010
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition
Multiple Sclerosis, Relapsing-remitting

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Fatigue in the Quality of Life of Patients With Multiple Sclerosis in Argentina

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demographic characteristics [ Time Frame: Initial visit (Day 0) ] [ Designated as safety issue: No ]
    Demographic and baseline variables include age, gender, race, baseline disease severity, sleep history, and baseline sleep assessments.

  • Duration of the disease [ Time Frame: Initial visit (Day 0) ] [ Designated as safety issue: No ]
    Identifying the number of years since disease onset.

  • 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) ] [ Designated as safety issue: No ]
    identifying the agents used for the treatment and the treatment duration.

  • 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) ] [ Designated as safety issue: No ]
    EDSS >=3,5 disability and EDSS <=3,5 no disability

  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: August 2008
Study Completion Date: November 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects diagnosed with MS in Argentina.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080001

Locations
Argentina
Hospital Fernandez de Buenos Aires
Capital federal, Buenos Aires, Argentina
Sponsors and Collaborators
Merck KGaA
Investigators
Principal Investigator: Dr. Norma Aydeé Deri Hospital Fernandez, Buenos Aires, Argentina
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01080001     History of Changes
Other Study ID Numbers: EMR 200077-506
Study First Received: March 2, 2010
Last Updated: March 6, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Merck KGaA:
Multiple sclerosis
Multiple sclerosis, Relapsing-remitting
Expanded Disability Status Scale
Fatigue
Hamilton Depression Inventory
Depression

Additional relevant MeSH terms:
Fatigue
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Signs and Symptoms
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014