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
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.
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.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01080027 -
Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR)
|
N/A | |
| Completed |
NCT02247310 -
BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With Betaferon
|
N/A | |
| Completed |
NCT01080053 -
Sexual Dysfunction, Disability and Quality of Life in Patients With Multiple Sclerosis (MS)
|
N/A | |
| Completed |
NCT00859482 -
Differential Immune Effects of Natalizumab
|
N/A | |
| Completed |
NCT02638038 -
This is a Randomized Study Comparing Two Doses of INT131 ( 3 mg and 1 mg) Administered Orally (PO) Daily (QD) Versus Placebo 1 Tablet PO QD in Subjects With Treatment-naïve RRMS for ≤ 3 Years
|
Phase 2 |