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

NCT01080001 | Completed DMC

• 1 other identifier: EMR 200077-506
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis, Relapsing-remitting

Keywords

Multiple sclerosis; Multiple sclerosis, Relapsing-remitting; Expanded Disability Status Scale; Fatigue; Hamilton Depression Inventory; Depression

Outcome Measures

Primary Outcomes (1)

• 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

  Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month)

Secondary Outcomes (6)

• Demographic characteristics

  Initial visit (Day 0)

• Duration of the disease

  Initial visit (Day 0)

• Treatment or treatment changes

  Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month)

• Expanded Disability Status Scale (EDSS)

  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)

  Each visit conducted from Day 0 (Initial visit) to the closure of the study (End visit at 24 month)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects diagnosed with MS in Argentina.

You may qualify if:

• Subjects with MS diagnosis (McDonald's criteria) in its relapsing remitting form
• Subjects between 21-60 years of age
• Subjects with more than 1 year since the MS diagnosis or with a clinically defined MS

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Hospital Fernandez de Buenos Aires

Capital Federal, Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Fatigue; Depression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Dr. Norma Aydeé Deri

  Hospital Fernandez, Buenos Aires, Argentina

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: August 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: November 1, 2012
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

AR (1)