Active clinical trials for "Multiple Sclerosis, Relapsing-Remitting"

This was an open-label, multicentric, prospective, post-marketing surveillance (PMS) study on the extent to which subject compliance is influenced by use of a variable titration regimen at the start of treatment of relapsing MS with Rebif.

Significant data from placebo-controlled clinical trials have demonstrated the efficacy of Rebif in relapsing remitting multiple sclerosis (RRMS) with reduction in relapse rate, delay in disability progression, and reduction in magnetic resonance imaging (MRI) activity and accumulation of lesion burden. Multiple sclerosis (MS), a chronic neurological diseases, can have diverse effects on the lives of subjects and their families. In controlled clinical trials, clinical measurement in MS has focused on impairments of neurological assessment using Expanded Disability Status Score (EDSS). The assessment of the impact of MS on the non-physical aspect of dysfunction is not often measured, or reported. Furthermore, traditional clinical measures have not been able to assess the effects of neurological illness on quality of life (QoL), which is becoming an increasingly important topic to neurologists treating subjects with varied neurological conditions. This observational, one arm, multicentric study is aimed to assess the usefulness of the Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) instrument in comparison with the Multiple Sclerosis Quality of Life-54 instrument (MSQOL-54 questionnaire) in RMS subjects on Rebif therapy and to assess the effectiveness of Rebif therapy using health related quality of life (HRQoL) measures.

To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with relapsing-remitting multiple sclerosis (RRMS), with a variety of baseline demographic characteristics.

The study is planned to evaluate the cognitive functions in subjects with RRMS treated with interferon beta-1a, and its relationship to the fatigue and neurological dysfunction status.

Natalizumab (NTZ) use in Multiple Sclerosis (MS) in highly active patients has been largely established during the last Rationale 10 years in both clinical trials and real-world practice. Along with its efficacy, NTZ use has been limited by potential risk of progressive multifocal leukoencephalopathy (PML). Thus, several studies have tried to assess how to minimize this risk. One suggested approach is to move from the standard interval dose (SID) of 4 weeks to an extended interval dose (EID) of 5 weeks or longer. Extending the dosing interval of NTZ has been practiced by some physicians with the intention of improving the benefit/risk of the treatment by reducing the exposure-dependent risk of progressive multifocal leukoencephalopathy (PML) while maintaining efficacy. We propose to retrospectively analyze data from clinical records coming from RRMS patients treated in France at 5 different centers; Caen, Nice, Bobigny and Toulouse hospitals as well as Percy Military Hospital, to evaluate the effectiveness of natalizumab EID in subjects who have previously been treated with natalizumab SID for 12 months, in relation to continued SID treatment. In the clinical practice of these centers, patients are shifted after minimum 12 months under SID to an EID of 6 weeks regardless antibody JC serum status. Clinical, magnetic resonance imaging (MRI) and serum anti-JCV antibody status data are collected when available. The objective of this study is to assess the efficacy in term of ARR and safety.

Multiple sclerosis (MS) is a chronic immune central nervous system (CNS) disease of unknown cause. Recent studies suggest that gut microbiota could be a trigger for the neuro-inflammation in MS and abnormal gut microbiota composition has been reported in MS patients. These data provided scientific rationale for microbiota-directed intervention, like stool transplant, for the treatment of MS.

Multiple sclerosis (MS) is an autoimmune disease, leading to inflammation and degeneration of neurons in the entire central nervous system (CNS). Not only does MS attack CNS white matter, the wiring of the brain, but it also affects so called grey matter, involved in communication between brain cells. Some studies have shown that grey matter damage and lesions to the outermost layer of the brain, the cortex, might serve as a better diagnostic and prognostic tool for MS patients. The issue is that cortical lesions only to a limited extent can be visualized by conventional magnetic resonance imaging (MRI) at 3 tesla. The new generation of ultra-high field MR scanners with a field strength of 7 tesla, has a higher sensitivity towards detecting these cortical lesions. We therefore wish to use the improved sensitivity of ultra-high field MRI to improve detection of cortical lesions, and to elucidate the detrimental effects of single lesions to the cortex, thereby improving both diagnosis and prognosis of the disease. By implementing newly developed ultra-high-resolution MR-sequences the amount and extent of cortical lesions to the area of the brain responsible of the sensory and motor function of the hand (sensorimotor hand area - SM1-HAND) will be investigated in patients with relapsing remitting and secondary progressive MS. We will also assess how these lesions affect manual dexterity and sensory function and how cortical lesions affect communication within brain areas. It is hypothesized that the amount and size of cortical lesions is highly involved in brain communication and manual function, a major problem in MS, and that this project will shed new light on how the disease damages this important brain area.

The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.

Since many years cognitive disorders are a main topic of clinical research in Multiple Sclerosis (MS) as there could be observed early on in the disease and could induce with time in patients significant socio-professional burden. Today assessment of cognitive dysfunction in MS is still based on traditional pencil-paper task tests which are not able to give a true representation of functional burden observed in patients in real life situations. The development of new tools close to these "life situations", i.e. more ecological, are needed to better assess and take in charge cognitive impairment in MS patients. One way to reach this goal is Virtual Reality (VR). VR offers a new human-computer interface paradigm that simulates a realistic 3D environment where the user become immersed and interacts with it. These last ten years VR has known a rapid development in the health domain and has been applied with success to motor rehabilitation, psychiatry and neuropsychology. In this last domain, virtual environment (VE) reproducing activities of daily living have been used to evaluate executive and memory functions as well as attentional or visuospatial processes. Among main VE developed, driving assessment system, navigation skills, cooking behaviors, virtual supermarket have shown better sensitivity to detect functional consequences of cognitive impairment in various neurological and psychiatric disorders than traditional evaluations. In Caen University Hospital, investigators used VE driving system and developed the use of the Virtual Action Planning in a supermarket (VAP-S ; Klinger et al 2004) where a user move to select and buy groceries and other things inside an interactive virtual supermarket using a shopping cart. In a preliminary study investigators have used this virtual interactive tool to evaluate executive functioning in small group of Parkinson's disease and MS patients. Analysis of initial data shows the feasibility of the VAP-S for use with these two kinds of diseases. According to these results investigators planned a new study in Relapsing-Remitting(RR)- MS patients where they compare the use of VE (driving system and the VAP-S) to traditional attentional and executive evaluation for estimate their respective sensitivity to detect cognitive/functional impairment in MS patients. Investigators hope to shown that VR will demonstrate its interest to assess cognitive functions in MS and to develop cognitive rehabilitation.

While the last several years have seen great strides in the treatment of relapsing forms of MS, progressive MS, responsible for the majority of MS-related disability, lags far behind. Despite much research, the lack of understanding related to what causes patients' relentless decline in function results in an inability to develop targeted treatment strategies suitable for clinical trials. This grant has two main goals. The first goal is to extend the investigators preliminary study on rat neurons treated with the CSF of MS patients to a larger number of Progressive patients in order to validate the initial findings and extend the study to include analysis of human neurons. The initiating PI (Dr. Casaccia) and the Partnering PI and Clinical Neurologist (Dr. Katz Sand) have recently identified components that are present in the CSF of progressive patients that impair the ability of rat neurons to produce energy. The partnering PI, Dr. Quinzii (Columbia University) together with collaborator Dr. Fossati (NY Stem Cells Foundation), have characterized human neurons generated from stem cells derived from skin biopsies of progressive patients and detected the presence of energetic deficits. The experimental plan will build on these results and test hypotheses of disease progression. The overall goal is to improve understanding on how to stop neurons from degenerating and stop clinical progression. The second goal is to ask whether it is possible to define a progressive disease course on the basis of combined biochemical, functional and imaging measurements. The initiating PI will be responsible for the biochemical assessment of CSF and serum samples and, together with partnering PI Quinzii, will also provide functional bioassays measurements of mitochondrial bioenergetics impairment in patients. These data will be combined with clinical assessment and MRI evaluations conducted by the partnering PI Katz Sand and collaborator Inglese. A two year clinical and imaging follow up from the initial recruitment will allow to define whether the combined measurements can be used by clinical neurologists to define the disease course and better identify therapeutic options for patients. The expectation is that the completion of the stated aims of research will allow an advancement of the current knowledge of the progressive form of MS and lead to potential new therapeutic targets.