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

Multiple Sclerosis, Relapsing Remitting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080040
• Other study ID #: EMR200077-507
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: October 13, 2013
• Start date: August 2008
• Est. completion date: March 2013

Study information

• Verified date: October 2013
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing Remitting
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Locations

Country	Name	City	State
Argentina	Fundación Rosarina de Neurorehabilitación	Rosario

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the prevalence of spasticity in subjects with RRMS	Ashworth Scale (AS) (Spasticity) Expanded Disability status scale (EDSS) SF 36	Initial visit (Day 0) to 24 months	No
Secondary	Evaluation of the impact of spasticity on the quality of life of subjects with RRMS		Initial visit (Day 0) to 24 months	No
Secondary	Evaluation of the changes in spasticity after 24 months		Initial visit (Day 0) to 24 months	No