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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01080040
First received: March 2, 2010
Last updated: October 13, 2013
Last verified: October 2013
  Purpose

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
Multiple Sclerosis, Relapsing Remitting

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Assess the prevalence of spasticity in subjects with RRMS [ Time Frame: Initial visit (Day 0) to 24 months ] [ Designated as safety issue: No ]
    Ashworth Scale (AS) (Spasticity) Expanded Disability status scale (EDSS) SF 36


Secondary Outcome Measures:
  • Evaluation of the impact of spasticity on the quality of life of subjects with RRMS [ Time Frame: Initial visit (Day 0) to 24 months ] [ Designated as safety issue: No ]
  • Evaluation of the changes in spasticity after 24 months [ Time Frame: Initial visit (Day 0) to 24 months ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: August 2008
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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.

  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 with established diagnosis of RRSM for more than one year.

Criteria

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
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: NCT01080040

Locations
Argentina
Fundación Rosarina de Neurorehabilitación
Rosario, Argentina
Sponsors and Collaborators
Merck KGaA
Investigators
Principal Investigator: Dr. Jose A. Brizuela Fundación Rosarina de Neurorehabilitación. Rosario, Argentina.
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01080040     History of Changes
Other Study ID Numbers: EMR200077-507
Study First Received: March 2, 2010
Last Updated: October 13, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Merck KGaA:
Multiple Sclerosis, Relapsing Remitting
Quality of life

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

ClinicalTrials.gov processed this record on November 27, 2014