Active clinical trials for "Multiple Sclerosis"

To assess the safety of endovascular therapy (balloon angioplasty) for venous stenoses in MS patients with CCSVI as documented by sonographic (extracranial echocolor-Doppler (ECD) and transcranial color Doppler (TCD) To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS). To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and MRI/MRV parameters. To evaluate change in patients self-reported QOL following the therapeutic angioplasty To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic angioplasty are associated with brain changes as measured by functional MRI (fMRI).

This is a prospective non interventional study including patients with Relapsing-Remitting Multiple Sclerosis (RRMS) or with Neuromyelitis Optica Spectrum Disorders (NMOSD) and healthy subjects, who are enrolled within the routinely programmed clinical examinations at the IRCCS Neuromed (Pozzilli, Italy), IRCCS Polyclinic Hospital San Martino (Genoa, Italy) and Sant'Andrea Hospital - University of Rome La Sapienza (Rome, Italy). Specifically, the study investigates how ozanimod may contrast neurodegenerative mechanisms triggered by both arms of the adaptive immune response (T and B cells) and by their suboptimal regulation in MS. Overall, the project aims at assessing by in vitro experiments (there will be no patients on treatment with ozanimod and the drug will be only used in vitro): AIM1: ozanimod ability to modulate the synaptotoxic effect of T-cells derived from patients with MS relapse in a MS-chimeric ex-vivo model and to identify possible mediators (IRCCS Neuromed-Pozzilli, in collaboration with Synaptic Immunopathology Laboratory Dep. Systems Medicine, Tor Vergata University of Rome); AIM2: ozanimod ability to reduce the cytokine-mediated breakdown of the BBB and the migration of the here studied immune cells through ex vivo models of BBB (IRCCS Polyclinic Hospital San Martino); AIM3: ozanimod ability to affect the migration properties of Epstein Barr virus (EBV) infected B cells in MS (Sant'Andrea Hospital); AIM4: ozanimod ability to modulate the number and/or function of regulatory T cells (Treg), a lymphocyte population playing a key role in the control of pathogenic adaptive immune responses (Treg Cell Laboratory, Università degli Studi di Napoli "Federico II", Naples, Italy, receiving blood samples from Neuromed Hospital and Sant'Andrea Hospital; not recruiting unit). The work of the four labs is conceptually and operationally integrated: the labs at IRCCS Neuromed-Pozzilli/Tor Vergata University (Aim1) and at Polyclinic Hospital San Martino (Aim2) will investigate the effects of ozanimod on well-known mechanisms of damage in MS, inflammatory synaptopathy and BBB damage and immune cell migration. The lab at Sant'Andrea Hospital (Aim3), will verify whether B cells infected by different EBV genotypes are involved in BBB migration, and how ozanimod may interfere with this mechanism. The Treg Cell Laboratory (Aim4) will investigate whether ozanimod can also act "upstream" of these mechanisms by regulating the adaptive immune response.

The primary objective of this study is to investigate whether Peg-IFN beta-1a improves the satisfaction of Relapsing-Remitting Multiple Sclerosis (RRMS) participants unsatisfied with injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction Questionnaire to Medication (TSQM-9), at 12 weeks. The secondary objectives of this study are to evaluate in this study population: effects of Peg-IFN beta-1a treatment on participants' satisfaction at 24 weeks; effects of Peg-IFN beta-1a treatment on short-term participants' adherence; effects of Peg-IFN beta-1a treatment on participants' fatigue; effects of Peg-IFN beta-1a on disease activity and physical disability; impact of Peg-IFN beta-1a treatment on participant-reported health-related quality of life; impact of Peg-IFN beta-1a treatment on participants' injection-system satisfaction; Evaluate the relationship between participants' satisfaction and adherence; Evaluate the relationship between participants' satisfaction and social-demographic factors (age, sex, employment working, level of education, etc) and clinical characteristics (annualized relapse rate [ARR], disability, etc.) and to evaluate the treatment safety and tolerability.

Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.

Patients diagnosed with any type of multiple sclerosis (MS) who show objective evidence of attention problems will be randomized to standard medical care (treatment as usual) or attention training, which will be completed at their home using a commercially available attention training task (Cogmed Working Memory Training - CWMT) for 5 weeks. Patients will undergo cognitive testing before and after intervention and at 6 months follow up.

Primary Objective: To characterize the pharmacodynamic profile of 2 treatment courses of alemtuzumab administered by subcutaneous injection and 2 treatment courses of alemtuzumab administered by intravenous infusion in patients with progressive multiple sclerosis. Secondary Objectives: To characterize the pharmacokinetic profiles of alemtuzumab administered by subcutaneous injection or intravenous infusion to patients with progressive multiple sclerosis. To characterize the safety and tolerability of alemtuzumab administered by subcutaneous injection or intravenous infusion to patients with progressive multiple sclerosis.

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.

The purpose of this study is to evaluate safety and clinical efficacy of DC-TAB in multiple sclerosis.

Our primary hypothesis is that a two weeks high-intensity task-oriented circuit training followed by a structured 3 months home exercise program would have higher benefits compared to a delayed-treatment group as control in people with multiple sclerosis and mild to moderate gait impairment. Our secondary hypothesis is that there could be retention of clinical gains in subjects that underwent TOCT plus structured 3 months home exercise program.

The purpose of this protocol is to collect data from approximately 15 multiple sclerosis (MS) patients who are participating in a pilot cooking course. This online cooking training program is currently available to general public through the company "Rouxbe" for a fee. Data gathered from this cooking course will be used to develop novel ways of promoting healthy eating habits in people with MS. The investigators will use the data from blood tests, questionnaires, and demographics to assess the feasibility and effectiveness of this program. This is an outpatient program designed for people with MS that would occur regardless of whether participant data is collected. This pilot cooking course will run for approximately four weeks. The investigators intend start to the training course in mid-March 2015. Subjects will be followed prior to course initiation for baseline data gathering, at four weeks from baseline, twelve weeks from baseline, and twenty-four weeks from baseline.