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To Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Multiple Sclerosis Patients

Sponsor
Merck KGaA, Darmstadt, Germany (Industry)
Overall Status
Completed
CT.gov ID
NCT01080040
Collaborator
(none)
150
Enrollment
1
Location
55
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is observational, non-controlled, multicentric and prospective, without experimental intervention or control. As part of the usual management of the subjects, scales will be used for the assessment of the spasticity and the quality of life (QoL).

The purpose of this observational study is to assess the incidence of spasticity in a group of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina and the way it affects the QoL of these subjects.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    One of most frequently observed symptoms in subjects with MS is spasticity. Spasticity is defined as an abnormal velocity-dependent increase in muscle tonic stretch reflexes due to an amplified reactivity of motor segments to sensory input. It is part of one of the components of the superior motoneurone syndrome and it may cause muscle rigidity and disability.

    The spasticity, which could be measured in electrophysiological, biomechanical and clinical terms, has a significant prevalence. It is a frequent cause for consultation among subjects with MS and, consequently, has a significant impact on the QoL. Men and those subjects with MS of longer duration are the most affected by spasticity.

    The aim of this study is to assess the impact that spasticity has on the QoL of subjects with MS.

    The total duration of the study is 24 months. The recruiting period will be 12 months. Once the recruiting time is over, the collection of data will continue during the full 24 months period that was planned.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Observational Study to Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Patients With Multiple Sclerosis in Argentina
    Study Start Date :
    Aug 1, 2008
    Actual Primary Completion Date :
    Mar 1, 2013
    Actual Study Completion Date :
    Mar 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Assess the prevalence of spasticity in subjects with RRMS [Initial visit (Day 0) to 24 months]

      Ashworth Scale (AS) (Spasticity) Expanded Disability status scale (EDSS) SF 36

    Secondary Outcome Measures

    1. Evaluation of the impact of spasticity on the quality of life of subjects with RRMS [Initial visit (Day 0) to 24 months]

    2. Evaluation of the changes in spasticity after 24 months [Initial visit (Day 0) to 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects aged from 21 60 years of age

    • Subjects with established diagnosis of RRMS according to the revised McDonald criteria

    • 2005

    • Subjects with a diagnosis of RRMS for more than one year

    • The subject who have signed the Informed Consent

    Exclusion Criteria:

    • Subjects with other causes of spasticity

    • Subjects with other clinical forms of MS (different from relapsing-remitting)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fundación Rosarina de Neurorehabilitación Rosario Argentina

    Sponsors and Collaborators

    • Merck KGaA, Darmstadt, Germany

    Investigators

    • Principal Investigator: Dr. Jose A. Brizuela, Fundación Rosarina de Neurorehabilitación. Rosario, Argentina.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck KGaA, Darmstadt, Germany
    ClinicalTrials.gov Identifier:
    NCT01080040
    Other Study ID Numbers:
    • EMR200077-507
    First Posted:
    Mar 3, 2010
    Last Update Posted:
    Oct 16, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Merck KGaA, Darmstadt, Germany
    Multiple Sclerosis, Relapsing Remitting
    Quality of life
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Multiple Sclerosis, Relapsing-Remitting
    Sclerosis

    Study Results

    No Results Posted as of Oct 16, 2013