Clinical trial NCT01080040: To Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Multiple Sclerosis Patients
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing Remitting
Keywords: Multiple Sclerosis, Relapsing Remitting
Quality of life
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-03-03
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with established diagnosis of RRSM for more than one year.

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.

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 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)

Primary outcomes:
measure: Assess the prevalence of spasticity in subjects with RRMS
timeFrame: Initial visit (Day 0) to 24 months
Secondary outcomes:
measure: Evaluation of the impact of spasticity on the quality of life of subjects with RRMS
timeFrame: Initial visit (Day 0) to 24 months
measure: Evaluation of the changes in spasticity after 24 months
timeFrame: Initial visit (Day 0) to 24 months
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Fundación Rosarina de Neurorehabilitación
Study officials:
affiliation: Fundación Rosarina de Neurorehabilitación. Rosario, Argentina.
name: Dr. Jose A. Brizuela
role: PRINCIPAL_INVESTIGATOR
References: