Central and Peripheral Nervous System Changes as Markers of Disease Progression in Multiple Sclerosis...
Multiple SclerosisNeurodegeneration6 moreOBJECTIVE To investigate neurodegeneration and demyelination in the central and peripheral nervous system in multiple sclerosis linked to disease progression and mechanisms that can explain different responses to Fampridine treatment in MS patients with walking disability. METHOD The study is a prospective cohort follow-up study with 98 participants with MS and walking disability. Participants are identified as responders or non-responders to Fampridine treatment prior to the study. Participants will undergo MRI of the cerebrum with lesion load quantification, neurophysiological tests comprised of motor evoked potentials and electroneurographic examination, blood samples examining KIR4.1 antibodies, brain derived neurotrophic factor (BDNF), myelin protein zero (MPZ), peripheral myelin protein 22 (PMP22), p75-nerve growth factor receptor (p75NGFR) and anti-myelin associated glycoprotein (anti-MAG). The presence of SORCS-3 gene mutation will also be examined, as will cerebrospinal fluid levels of myelin basic protein, neurofilament heavy and light chains. Functional test of Timed 25-foot walk test (T25FW) will identify response to Fampridine treatment. A functional test battery will further detail function of upper extremities and cognition. CONCLUSION This study will add to the understanding of neurodegeneration and demyelination in CNS and PNS in patients with MS having walking disability. This will impact clinical decision-making by improving organization of immunomodulatory treatment, identifying biomarkers thus facilitating earlier treatment and improving patient control, information and education.
MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
Multiple SclerosisThe purpose of this study is to better characterize the fluctuations in multiple sclerosis symptoms and their relationship to medications, to length/extent of disease, and to a variety of physiologic measures.
An Observational Study on Teriflunomide-exposed Pregnancies
Multiple SclerosisPrimary Objective: To evaluate any potential increase in the risk of major birth defects, in the first year of life, in teriflunomide-exposed pregnancies. Secondary Objective: To evaluate the potential effect of teriflunomide-exposure on other adverse pregnancy outcomes including any potential pattern of minor birth defects, spontaneous abortion, stillbirth, preterm delivery, small for gestational age at birth and at 1 year follow-up.
Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis
Multiple SclerosisFampyra, a voltage-dependent potassium channel blocker, is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). The medicinal product has been authorized under a so-called "conditional approval" scheme. This means that further evidence on this medicinal product is awaited and this study aims to assess the effect of Fampyra, administered according to standard clinical practice, on cognition, fatigue and quality of life in patients with MS. This clinical study is a multicenter, prospective, non-interventional, cohort study of MS patients receiving Fampyra in outpatient setting. Patients will be treated according to the local prescribing information of the study medication and routine medical practice in terms of visit frequency and types of assessments performed. The assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of Fampyra is clearly separated from the physician's decision to include the patient in the current study. Since this is purely non-interventional study, primary data -which will be obtained prospectively during the study visits through patients' interview and patient reported outcomes or as performed per standard clinical practice- will mainly be employed.
Evaluating the Efficacy and Safety of Transitioning Patients From Natalizumab to Ocrelizumab
Relapsing Remitting Multiple SclerosisThe primary objective of this study is to assess the efficacy of Ocrelizumab (OCR) in Relapsing Multiple Sclerosis patients who have been previously treated with natalizumab (NTZ) by evaluating relapse rate, progression on MRI and disability progression.
Rebif Compliance Support Program - Assessing Needs in Multiple Sclerosis
Multiple SclerosisThis 1-arm, open-label, multicentric, observational study aims to collect subject centric information in line with routine care. Subjects' expectations of therapy, side effect management and lifestyle may influence adherence to therapy. This survey aims to determine whether such factors and/or others affect the successful initiation and maintenance of Rebif therapy. The data collected during this study will include information on the subject's treatment including expectations, experience, training and support. The results of the study will be used to understand the impact on subjects' compliance and tailor training and support services to subject's need. It will also be made available to other healthcare organisations involved in the subjects treatment.
Correlation Between Multiple Sclerosis Functional Composite (MSFC) and Expanded Disability Status...
Multiple SclerosisThis observational study is being conducted to evaluate the usefulness of the MSFC and its relationship with EDSS scores in subjects with MS in Argentina.
Sexual Dysfunction, Disability and Quality of Life in Patients With Multiple Sclerosis (MS)
Multiple SclerosisRelapsing RemittingThis is an observational, prospective, non-interventional, non-controlled study planned to be conducted in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS). The purpose of this observational study is to determine the correlation between the degree of disability and sexual dysfunction; and between the sexual dysfunction and the quality of life (QoL) of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina.
Functional and Physiological Responses to Lokomat Therapy (Pilot Study)
Spinal Cord InjuriesMultiple Sclerosis1 moreIndividuals with neurological deficiencies such as those who have spinal cord injury, stroke, traumatic brain injury, Parkinson's disease, and multiple sclerosis often lose their ability to ambulate over ground. Loss of functional mobility not only impedes everyday life, but may also affect many systems and organs in the body. The investigators are interested in obtaining a wide variety of data in order to obtain a better understanding of changes that occur as a result of receiving Lokomat therapy. The investigators will be studying body composition, cardiac, pulmonary, endocrine, metabolic, and molecular changes after a 12-week clinical therapy program.
Tolerability of Rebif® (Interferon-beta 1-A) Therapy in Korean Patients With Multiple Sclerosis...
Multiple SclerosisThis is an observational study to assess the tolerability of Rebif treatment in Korean multiple sclerosis (MS) subjects.