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Multiple Sclerosis, Relapsing-remittingNCT01080001

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

An observational study of Multiple Sclerosis, Relapsing-remitting, run by Merck KGaA, Darmstadt, Germany at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 60 years
Conditions the study is for
Multiple Sclerosis, Relapsing-remitting
How many people
71 participants
Where
1 siteArgentina
Study dates
Aug 2008to Nov 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Subjects diagnosed with MS in Argentina.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Hospital Fernandez de Buenos Aires

    Capital Federal, Buenos Aires

Other trials in Argentina

About this study

Official title: 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.

Read the 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.

Keywords
Multiple sclerosis, Multiple sclerosis, Relapsing-remitting, Expanded Disability Status Scale, Fatigue, Hamilton Depression Inventory, Depression
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Fatigue, Depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (6)

  1. Demographic characteristics

    Demographic and baseline variables include age, gender, race, baseline disease severity, sleep history, and baseline sleep assessments.

    Measured: Initial visit (Day 0)

  2. Duration of the disease

    Identifying the number of years since disease onset.

    Measured: Initial visit (Day 0)

  3. Treatment or treatment changes

    identifying the agents used for the treatment and the treatment duration.

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

  4. Expanded Disability Status Scale (EDSS)

    EDSS >=3,5 disability and EDSS <=3,5 no disability

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

  5. Hamilton Depression Inventory-17 (HDI-17)

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

  6. Fatigue Severity Scale (FSS)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2010 (estimated)
  2. Study startAug 2008
  3. Primary completionDec 2010
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01080001
Sponsor's protocol ID
EMR 200077-506
Status last verified
Mar 2014
First submitted
2 Mar 2010
Last updated
7 Mar 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, Relapsing-remitting, run by Merck KGaA, Darmstadt, Germany at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01080001.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2014.

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