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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Multiple Sclerosis, Relapsing Remitting

Study type: Observational

Funder types: Industry

Identifiers

NCT01080040

EMR200077-507

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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)