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OpenTrials
Completed

NCT Number: NCT01080040

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

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.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundación Rosarina de Neurorehabilitación

Rosario, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Assess the prevalence of spasticity in subjects with RRMS

    Time frame: Initial visit (Day 0) to 24 months

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

Secondary outcomes

  1. Evaluation of the impact of spasticity on the quality of life of subjects with RRMS

    Time frame: Initial visit (Day 0) to 24 months

  2. Evaluation of the changes in spasticity after 24 months

    Time frame: Initial visit (Day 0) to 24 months

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

Observational Study to Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Patients With Multiple Sclerosis in Argentina

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Mar 3, 2010
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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