Active clinical trials for "Multiple Sclerosis"

The purpose of this study is to describe respiratory disorders in patients with severe multiple sclerosis (EDSS from 6.5).

Objectives: Dimethyl fumarate (DMF) therapy may cause a measureable change in bacterial species of the gut. The primary objectives of this study are: Determine whether a measureable change in bacterial species representation follows the institution of DMF. Determine whether a specific pattern of change in the microbiota phylotype with DMF therapy correlates to onset and severity of gastrointestinal disturbances (heartburn, nausea, flatulence, and diarrhea). Determine whether any instability of microbiota phylotype representation persists following the institution of DMF or whether stabilization relates to resolution of gastrointestinal disturbances. Determine whether there is a correlation between a pre-existing functional bowel disorder and development or severity of gastrointestinal disturbances and of peripheral eosinophilia. Design: Double-blinded, prospective, single-center pilot study. Patient Population: Individuals 18 years or older, with a confirmed diagnosis of a relapsing form of multiple sclerosis. Treatment Groups: This study will be an open-label prospective study design with respect to MS immunomodulatory therapy choice. Study group will be defined as subjects with a relapsing form of multiple sclerosis, as defined by the McDonald criteria, choosing to begin DMF therapy.

This study will identify a combination of disease severity markers (genetic, immunology, epigenetic, imaging) associated with disease severity and progression in a cohort of patients with multiple sclerosis.

OFSEP is an observational cohort of Multiple Sclerosis (MS) and related disorders set up in France. It aims to provide a major epidemiological tool on MS for the scientific community in France and abroad. This tool must help to answer a large number of questions concerning the causes and mechanisms of MS, the prognostic factors of disease progression, the effectiveness and safety of therapeutic drugs, the impact of the disease on patients and society, etc. In December 2015, it has already included more than 54.000 patients. To achieve this goal, OFSEP's objectives are To maintain and develop the French cohort of patients suffering from MS or related diseases and syndromes. This means collecting standardized socio-demographic and clinical data as part of the routine medical follow-up of patients already in the cohort and recruitment of new patients. To supplement the existing clinical data with standardized and quality biological samples and MRI scans. To improve the previous data with medical/administrative data from the health insurance fund databases in particular, in order to get more information on comorbidity, treatment protocols and the medico-economic aspects of this disease. To use OFSEP infrastructures to facilitate the implementation of specific studies requiring the collection of additional data or specific patient monitoring processes. To ensure the availability of these data and samples to researchers, health care authorities and industrial players to enable analysis and thus provide answers to research questions or public health issues. This availability is only possible after scientific and regulatory evaluation of the request. To provide regular descriptions of the patient population in the cohort to offer statistics, targets and up-to-date information on this disease and thus enable a better approach to the personal, professional and social impacts of the illness, the effects of basic treatments and the requirements related to the follow-up of this disease in France. To conduct specific studies on the entire population of patients in the cohort (parent cohort) or on patient sub-groups with specific characteristics (nested cohorts). Four nested cohorts have been defined: patients with radiologically isolated syndromes, patients with clinically isolated syndromes, patients with primary progressive courses of the disease and patients with neuromyelitis optica (Devic's syndrome) spectrum disorders.

The aim of this project is to characterize the influence of a ketogenic diet and intermittent therapeutical fasting on the course of the disease, as measured by T2-hyperintense cerebral lesions with magnetic resonance tomography (MRT) in patients with multiple sclerosis (RRMS). The investigators expect in both intervention groups fewer cerebral T2 lesions occurring after 18 months in comparison to the control group and as detectable by MRT. According to current recommendations of the German Society of Nutrition (DGE), the control group receives a vegetarian-focused, anti-inflammatory diet.

Compared with MS in white populations, in people of China descent multiple sclerosis (MS)is characterized by lower prevalence, more frequent and severe involvement of the visual system at onset and during the entire clinical course, more common occurrence of optic and spinal involvement, relatively rapid progression and less common occurrence of a progressive course. Data are not available for mainland China that are focused on characteristic studies of MS. In this study, the investigators sought to explore the characteristics of MS among Chinese in China, by conducting a study on genetics, pathogenesis, pathology, neuroimaging characteristics, and so on. Based on these data, the investigators try to explore the difference in neuromyelitis optical (NMO) and MS and provide clinical data for treatment guidelines for NNO and MS.

The investigators hypothesize that the endogenous cannabinoid signalling system has lost homeostasis in the disease multiple sclerosis (MS). To investigate a novel action of dietary fish oils, the investigators will administer a food frequency questionnaire to both healthy subjects and patients with MS. The investigators will first determine if there are differences between both populations of endogenous cannabinoids, and then determine whether dietary intake of fish oils alters these levels

It has been almost 25 years since the publication of the pivotal trial results for the first disease-modifying therapy (DMT) for RRMS. Currently disease modifying therapies (DMTs) for MS approved by the European Medicine Agency (EMA) and Food and Drug Administration (FDA) include interferon beta (IFNβ) 1-a and 1-b, glatiramer acetate (GA), mitoxantrone, natalizumab, fingolimod, teriflunomide, dimethyl fumarate, alemtuzumab, daclizumab and ocrelizumab. Despite evidence about ocrelizumab exist in many patients from eurpe and North America, scarce real world evidence exists about epidemiolofcal aspects of patients that used ocrelizumab in Latin America. The aim of this study is therefore to evaluate patient profiles and persistence to treatment during follow up in a retrospective study of patients who had been prescribed ocrelizumab for the treatment of MS in Latin America (LATAM). The investigators will include MS patients that received ocrelizumab in Latin America and describe epidemiological aspects and persistence to treatment during the last 12 months.

A randomized, controlled pilot trial of a dietary intervention vs. wait-list control in patients with MS and fatigue for management of their fatigue. The hypothesis of this study is that participants following the low-fat study diet will demonstrate a significant reduction in fatigue after four months compared to wait list controls.

The development and progression of multiple sclerosis seem to be driven by concomitant inflammation and, to a less well-defined degree, disturbances in metabolism of individual cells of the human central nervous system as well as changes in the dynamical supply of blood to the brain. These alterations in normal physiology can be quantified by investigating the change in specific parameters over the time course of multiple sclerosis evolution. Amongst these specific parameters, the ability of the so-called blood-brain-barrier to selectively filter nutrients from the blood stream prior to passage into the nervous tissue, is disrupted in multiple sclerosis, and the severity of this deficiency seem to be related to the underlying disease burden. The present study utilises a novel imaging technology in order to monitor changes in the integrity of the blood-brain-barrier over the course of treatment with a biological disease modifying agent known as alemtuzumab. Alemtuzumab is a potent immunosuppressant drug. It is hypothesised that alemtuzumab reverts the deficiency in blood-brain-barrier integrity and, conversely, the severity of blood-brain-barrier disruption at several time points during alemtuzumab treatment can be utilised as prognostic marker for the requirement of additional administration of alemtuzumab beyond the regular treatment regimen. In addition, several other factors are investigated by advanced imaging techniques in combination with blood and urine samples in order to elucidate the possible underlying mechanism of alemtuzumab efficacy. It is hypothesized that alemtuzumab normalises metabolic alterations and changes in the blood supply through resolution of inflammation in the brains of multiple sclerosis patients.