A Multicenter, Double- Blind, Placebo- Controlled Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera® (Dimethyl Fumarate) Delayed Release Capsules
The primary objective of this study is to evaluate whether montelukast can reduce the severity of gastrointestinal (GI) events, measured by the Gastrointestinal Symptom Rating Scale (GSRS), after oral administration of dimethyl fumarate (DMF) in participants with relapsing forms of Multiple Sclerosis (MS). The secondary objectives of this study are as follows: To evaluate whether montelukast after oral administration of DMF in participants with relapsing forms of MS decreases discontinuations due to GI events and reduces the number of participants taking symptomatic therapies for GI events; To investigate the effect of montelukast on the incidence of flushing events after oral administration of 240 mg DMF in participants with relapsing forms of MS.
NCT02410278 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT02410278/
Assistive Device Training for Functional Mobility and Connectivity in Multiple Sclerosis
The purpose of this study is to determine whether a training program in the use of ambulatory assistive devices (such as canes, walkers, etc) can reduce falls and increase functional mobility and neural connectivity in people with Multiple Sclerosis.
NCT02408718 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT02408718/
Analysis of a Biomarker Signature, Consisting of Toll-like Receptor 2 (TLR2), TLR4 and CCR1, by Flow Cytometry in Patients With MS Treated With Gilenya (FTY720)
This study investigates whether there is a link between disease activity/progression in patients receiving Gilenya and expression of a putative biomarker signature in patients with multiple sclerosis.
NCT02408380 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT02408380/
Intensity Depended Impact of a Single Exercise Bout on Cognitive Functions in Persons With Multiple Sclerosis - a Pilot Study
Multiple Sclerosis (MS) is a chronic autoimmune disease where lymphocytes inflict damage to the axons and myelin sheaths of the central nervous system. Persons with multiple sclerosis (pwMS) were long advised to avoid physical activity but the benefits of exercise to improve cardiovascular and cognitive functions in pwMS have become important aspects of standardized rehabilitation programs. Recent findings show that the achieved adaptations through exercise are associated with the intensity dependent lactate increases during exercise. This dose-response relationship between the mode and the exercise intensity implicates the relevance of the exercise protocol as higher exercise intensities seem to facilitate greater benefits, also in pwMS. This pilot study evaluates the influences of acute bout of moderate physical exercise (cycling) and relaxation on cognitive functions at three time points. Primary outcomes are the differences (at timepoint t2) of cognitive functions assessed via the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test Revised (BVMT-R) T1-3 of the BICAMS battery. Results should into a randomised controlled Trial that investigates the specific influences of a three-week training intervention on Brain-derived neurotrophic factors (BDNF), Insulin Growth Factor-1 (IGF-1) and Vascular Endothelial Growth Factor (VEGF) as central neurobiological parameters of neuroplasticity, cardiorespiratory Fitness and cognitive functions.
NCT02408367 — Multiple Sclerosis
Status: Unknown status
http://inclinicaltrials.com/multiple-sclerosis/NCT02408367/
Treatment of Multiple Sclerosis With Mesenchymal Stem Cells: Phase I/II Study
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS), which ultimately leads to myelin damage and axonal loss. The disease is complex and multifactorial, but the key pathogenic event appears to be an uncontrolled response of components of the immune system (T and B lymphocytes) to myelin proteins. No definitive treatment is available for MS, however immunomodulatory and immunosuppressant drugs act as disease-modifying agents (DMDs). Unfortunately, the current treatments demonstrate partial efficacy in targeting the deleterious immune reactions. According to the present knowledge of the pathophysiology of MS, an ideal therapeutic strategy would be to modulate or suppress the aggressive immune process, to protect axons and neurons from degeneration, and to enhance repair and facilitate remyelination. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown remarkable ability to modulate the immune response. This study will evaluate the safety of injecting MSCs in people with MS.
NCT02403947 — Multiple Sclerosis
Status: Terminated
http://inclinicaltrials.com/multiple-sclerosis/NCT02403947/
Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis
The aim of this study is to develop novel magnetic resonance imaging (MRI) protocols suitable for patients with multiple sclerosis using advanced MRI such as rotating frame relaxation imaging. In addition, the investigators want to study the correlation between advanced MRI parameters and clinical disease progression.
NCT02403570 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT02403570/
A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.
NCT02398461 — Multiple Sclerosis, Acute Relapsing
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis-acute-relapsing/NCT02398461/
Characterizing Upper Extremity Function in Individuals With Multiple Sclerosis
Upper extremity (UE) function is critical to maintaining independence. Better understanding of UE involvement in MS will provide necessary information to prioritize the design and selection of future interventions. The goal of the proposed project is to characterize UE involvement in a population of community-based persons with MS across the International Classification of Functioning, Disability & Health (ICF) domains and constructs.
NCT02398149 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT02398149/
A Prospective, Observational, International, Multi-center Study to Measure the Relationship Between Relapse and Adherence in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With Rebismart®2.0 + MSdialog™, Assessing Quality of Life (ADHERQOL)
This is a 24-month, observational, prospective, multinational, multicenter study to determine the relationship between the relapse (percentage of relapse free subjects) and adherence in subjects diagnosed with RRMS treated with Rebif (interferon beta-1a) using the RebiSmart®2.0 and MSdialog™.
NCT02394782 — Multiple Sclerosis, Relapsing-remitting
Status: Terminated
http://inclinicaltrials.com/multiple-sclerosis-relapsing-remitting/NCT02394782/
Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis
Primary fatigue represents a major cause of disability in patients with multiple sclerosis (MS), being reported in about 90% of cases. Fatigue interferes with everyday functioning but, unfortunately, little is known about its mechanisms. The investigators propose a characteristic eye movement abnormality (internuclear ophthalmoparesis, INO), commonly encountered in MS, as a simple model for primary motor fatigue. The investigators described worsening of ocular performance in MS patients with INO following visual tasks (ocular motor fatigue), which is likely due to decreased neural conduction along brain pathways injured by MS. This mechanism could represent a major component of MS-related primary motor fatigue. Relevant to Veterans' care, INO is a significant cause of visual disability, especially when complicated by ocular fatigue, and limits daily activities such as reading and driving. The investigators propose a medical treatment to improve ocular performance/fatigue in INO, which can reduce visual disability and improve quality of life in Veterans with MS.
NCT02391961 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT02391961/