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

The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with chronic inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments. No reparative therapies exist for the treatment of multiple sclerosis. Clemastine fumarate was identified along with a series of other antimuscarinic medications as a potential remyelinating agent using the micropillar screen (BIMA) developed at the University of California, San Francisco (UCSF). Following in vivo validation, an FDA IND exemption was granted to investigate clemastine for the treatment of multiple sclerosis in the context of chronic optic neuropathy. That pilot study was recently completed and is the first randomized control trial documenting efficacy for a putative remyelinating agent for the treatment of MS. The preselected primary efficacy endpoint (visual evoked potential) was met and a strong trend to benefit was seen for the principal secondary endpoint assessing function (low contrast visual acuity). That trial number was 13-11577. This study seeks to follow up on that study and examine clemastine fumarate's protective and reparative effects in the context of chronic demyelinating brain lesions as imaged by multi-parametric MRI assessments. The investigators will be assessing the effects of clemastine fumarate as a remyelinating therapy and assessing its effect on MRI metrics of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis. In addition to using conventional multi-parametric MRI assessments, this study will also evaluate a new MRI technique called Ultrashort Echo Time (UTE) MRI to assess the effects of clemastine fumarate as a remyelinating therapy of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis and compare it to the other assessments.

The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).

The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) thought to aid in memory will improve verbal retrieval in multiple sclerosis patients. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.

Rationale: Natalizumab is an effective drug in the treatment for relapsing remitting multiple sclerosis (RRMS) and is approved by de FDA/EMA in a treatment regimen of 4-weekly 300mg natalizumab infusions. Natalizumab trough concentrations after a 4-weekly interval are high in the large majority of patients which implies a relative overdose in most patients. A recent randomized controlled trial (RCT) suggests natalizumab maintains a high level of effi-cacy in stable patients with RRMS switching to a 6 week interval. Our study group demon-strated that efficacy of natalizumab is maintained when the infusion interval is extended based on natalizumab trough concentrations (personalized extended interval dosing). This leads to fewer hospital visits, a decrease of healthcare costs and decrease of risk of compli-cations of natalizumab treatment. Objective: Our objective is to test feasibility and validate safety of personalized extended interval dosing of natalizumab starting from 6 weeks in a large real-life cohort across the Netherlands. Study design: Prospective national phase IV natalizumab cohort study. Study population: All patients, aged 18 years or older, who are currently treated with natalizumab in the Netherlands for RRMS, with a minimum of 6 consecutive infusions. Intervention: All patients currently included in the NEXT-MS trial will receive an adjusted personalized extended interval dosing treatment regimen of natalizumab based on natalizumab concentrations starting from an infusion interval of 6 weeks. Main study parameters/endpoints: Our main study endpoint is the safety (defined by radiological disease activity) of personalized natalizumab dosing in a large real-life cohort across the Netherlands. Data will be collected regarding disease activity and disability progression. A cost analysis will be performed to show the extent of cost reduction. Patients will be annually followed to assess the influence of personalized dosing on JC virus conversion, JC virus index, incidence of progressive multifocal leukoencephalopathy, treatment satisfaction and quality of life. The influence of personalized dosing on pharmacokinetics will be monitored.

The study seeks to investigate safety and efficacy of ixazomib (NINLARO), a proteasome inhibitor, in multiple sclerosis (MS). Participants will receive either ixazomib capsules or placebo capsules for up to 24 months.

The overarching goal of this project is to critically evaluate the efficacy of incorporating dietary guidance within multiple sclerosis (MS) care for improving long-term quality of life (QoL) compared to usual care. The primary objective of this study is to evaluate the effect of two dietary interventions (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination) on MS QoL compared to usual care control (Dietary Guidelines for America), and the secondary objectives and the long-term effects on, motor function, low-contrast vision sensitivity, fatigue, mood, and disease activity assessed by brain imaging.

The purpose of this study is to test the effects of two dietary interventions, glycemic load and calorie restriction, on physical function, cognition, pain, fatigue, mood, and anxiety in adults with multiple sclerosis (MS). The investigators will also explore the how the diet interventions impact inflammation, immunity, and metabolic biomarkers.

Multiple sclerosis (MS) is a central nervous system inflammatory disease that causes a chronic and progressive physical handicap. Though primarily considered as a motor disease, it may, in 40 to 65% of cases, cause cognitive function deficits, concerning mainly attention, information processing speed, executive functions and memory. The impairment of these various functions may significantly impair the patients' social, professional and family lives. As such, the presence of cognitive difficulties is more frequently associated with the onset of anxio-depressive psychiatric symptoms and with reduced quality of life to the extent that it can be estimated via psychometric scales, or by a more qualitative approach. Recent research has focused, not on demonstrating the existence of cognitive disorders in MS, but rather on attempting to reduce their daily impact through cognitive rehabilitation programmes. While encouraging, the available results are relatively discordant and further work is required to demonstrate the actual efficacy of such programmes applied to daily life and of their long-term effects. The main objective of this work is to evaluate, in patients suffering from MS and presenting with cognitive disorders and/or with complaints, the effect of an innovative computerised, semi-autonomous at-home cognitive rehabilitation programme, following care, on quality of life. The secondary objective is to estimate the improvement, or even stabilisation over time, of patients' cognitive performance and psycho-affective sphere. In this randomised trial, the investigators plan to include 40 patients suffering from the RR and SP forms of MS, distributed to two groups paired by age, gender and socio-cultural level, one of which will benefit from computerised management, along with at-home support from a psychologist, while the other receives only the support. This work is expected to provide two types of benefits. Firstly, to enable patients to better understand their cognitive function via daily management and as such to improve their quality of life and self-esteem. Secondly, to eventually allow more appropriate patient management by combining the quasi-systematic use of this programme with follow-up consultations with referring practitioners (neurologists, psychologists, etc.).

A growing body of work suggests that regular exercise can support symptom management and improve physical function for people living with multiple sclerosis (MS). Although exercise is known to be beneficial for managing many symptoms related to MS, its effects on the central nervous system, and whether these effects change with different types of exercise, are not well understood. Here, the investigators have designed a clinical trial that compares the effects of distinct exercise protocols on aspects of physical function, physical fitness, and central nervous system function. This research will be the first to compare the effects of different types of exercise on central nervous system changes in people with MS.

A key question in efforts to reduce symptoms and improve quality of life for multiple sclerosis (MS) patients is whether a therapeutic lifestyle (diet, stress reduction and exercise) is inferior to disease-modifying drug treatments in terms of reducing multiple sclerosis related symptoms, improving function and quality of life, and reducing the number of acute inflammatory lesions and loss of brain volume. This study will prospectively assess the changes in quality of life and clinical outcomes in two cohorts of patients who are recently diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) to begin answering that question. The goal of this project is to compare a diet and therapeutic lifestyle only treatment usual care in the setting of newly diagnosed individuals with RRMS or CIS, which is the precursor to the development of MS. Due to the COVID 19 Pandemic, the study was redesigned from an in-person study to a virtual visit only study prior to enrolling study subjects.