Multiple Sclerosis, Relapsing-remitting Clinical Trial
Official title:
Impact of Fatigue in the Quality of Life of Patients With Multiple Sclerosis in Argentina
This is an observational, non-controlled, multicentric, prospective study planned to be conducted in 66 subjects diagnosed with multiple sclerosis (MS) in 20 centres of Argentina. Fatigue is recognized as one of the most frequent symptoms of MS with a high incidence in MS subjects. The link between fatigue and the degree of disability and other manifestations of the disease, such as depression has not been yet clearly understood. Hence, this study aims to understand the way in which fatigue impairs the quality of life (QoL) of MS subjects. This epidemiologic study can contribute to a better understanding of the way in which fatigue correlates with depression and the intensity with which both situations impact on the QoL of MS subjects.
Fatigue is recognized as one of the most frequent symptoms of MS and its impact on QoL of
subjects is high. Fatigue in MS is sometimes considered as a prodromic symptom or as a
peculiar symptom that must be differentiated from natural fatigue, pathological fatigue of
other chronic diseases; as well as from fatigue caused by the excessive effort in case of
gait disorder, spasticity or paresis. The origin of the fatigue symptom in MS is unknown and
the cause is likely to be multifactorial. The evaluation of the fatigue is challenging, due
to its variability and hence, scales such as Krupp's Fatigue Severity Scale (FSS) has been
developed for measuring MS fatigue.
OBJECTIVES
Primary objective:
- To determine the impact of fatigue on QoL of MS subjects in Argentina
Secondary objective:
- To evaluate correlation between FSS and disability, depression, demographic variables;
and between FSS and the use of disease modifying drugs
- To determine the impact of depression and neurological disability on QoL of MS subjects
in Argentina
The subjects will be managed with the clinical and therapeutic elements that the treating
doctor considers appropriate, without modifying their decisions due to the subject inclusion
into the study. The epidemiologic data required by this study will be collected by the
investigator from the documents in which each subject visit is registered, whether
programmed or not. Once the recruiting period of 12 months is over, the collection of data
will continue during the full 24 months period for each subject. The closure of the study
will be marked by the follow-up of the last subject who entered the study.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02861014 -
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
|
Phase 3 | |
| Terminated |
NCT01435993 -
Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis
|
Phase 1 | |
| Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
| Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
| Completed |
NCT02410200 -
Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS
|
Phase 2 | |
| Completed |
NCT03975413 -
Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis
|
||
| Completed |
NCT05080270 -
Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis
|
Early Phase 1 | |
| Completed |
NCT01116427 -
A Cooperative Clinical Study of Abatacept in Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT01108887 -
An Observational Study for the Assessment of Adherence, Effectiveness and Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmart™.
|
N/A | |
| Completed |
NCT01141751 -
An Observational Study Comparing Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Multiple Sclerosis Quality of Life-54 Instrument (MSQOL-54) in Relapsing Multiple Sclerosis (RMS) Patients on Long-term Rebif® Therapy
|
N/A | |
| Completed |
NCT00097331 -
Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT01909492 -
Measurement of Relaxin Peptide in Multiple Sclerosis (MS)
|
||
| Completed |
NCT04121221 -
A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
|
Phase 3 | |
| Withdrawn |
NCT04880577 -
Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis
|
Phase 2 | |
| Not yet recruiting |
NCT05290688 -
Cellular microRNA Signatures in Multiple Sclerosis
|
N/A | |
| Completed |
NCT04528121 -
Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis
|
N/A | |
| Recruiting |
NCT04002934 -
Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis
|
Phase 2 | |
| Recruiting |
NCT05019248 -
Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine
|
||
| Completed |
NCT04580381 -
Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort
|
||
| Completed |
NCT00071838 -
Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis
|
Phase 2 |