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

NCT01080040 | Completed

• 1 other identifier: EMR200077-507
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing Remitting

Keywords

Multiple Sclerosis, Relapsing Remitting; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Evaluation of the impact of spasticity on the quality of life of subjects with RRMS

  Initial visit (Day 0) to 24 months

• Evaluation of the changes in spasticity after 24 months

  Initial visit (Day 0) to 24 months

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with established diagnosis of RRSM for more than one year.

You may qualify if:

• 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

You may not qualify if:

• Subjects with other causes of spasticity
• Subjects with other clinical forms of MS (different from relapsing-remitting)

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Fundación Rosarina de Neurorehabilitación

Rosario, Argentina

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dr. Jose A. Brizuela

  Fundación Rosarina de Neurorehabilitación. Rosario, Argentina.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: August 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

AR (1)