Active clinical trials for "Multiple Sclerosis"

We hypothesize that the novel melanocortin-mediated anti-inflammatory effects of ACTH will reduce axonal loss following ON by limiting inflammatory optic nerve injury. We will compare the effect of ACTH and intravenous methylprednisolone therapy on axonal injury following ON using OCT, a sensitive, reproducible and noninvasive tool to measure RNFL thickness. The primary outcome will be the average RNFL thickness at 6 months. Additional pre-specified statistical analyses will compare the difference in the mean RNFL thickness at 6 months in the affected eye between the IV methylprednisolone- and Acthar-treated groups, and the mean 6-month affected eye RNFL thicknesses adjusted for the baseline unaffected eye RNFL. The secondary outcome measure will examine the frequency of optic nerves with RNFL swelling between the IV methylprednisolone- and Acthar-treated groups at 1 and 3 months. A predefined exploratory outcome will compare the ganglion cell plus inner plexiform layer (GC+IPL) thickness at 6 months between treatment groups. Additional tertiary outcome will be the assessment of changes in fatigue, mood, visual function depression, and quality of life in patients with AON. Assessment will be completed by administration of the following questionnaires: Modified Fatigue Impact Scale, Multiple Sclerosis Quality of Life 54 Instrument, 25-item Visual Function Questionnaire with 10-item supplement, Beck's Depression Inventory. These questionnaires have been validated for the MS (AON) population. Descriptive and correlative analysis will be done at each visit time point to assess for QOL for this study population.

This is a Phase IV, prospective, open-label, multi-center trial to assess the treatment satisfaction in patients with relapsing forms of Multiple Sclerosis (MS) who are currently being treated with, but are considering discontinuing treatment with Tecfidera™.

PF-06342674 (RN168), being developed for the treatment of multiple sclerosis (MS), is an antibody that binds to and inhibits the human interleukin-7 receptor, a component potentially involved in MS. PF-06342674 (RN168) is expected to play a role in slowing down the progression of the disease.

The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta). The secondary objectives were: Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on: Disease activity as measured by brain Magnetic Resonance Imaging (MRI) Disability progression Burden of disease and disease progression as measured by brain MRI Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy Assess associations between variations in genes and clinical outcomes (safety and efficacy) Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit)

This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of the placebo-controlled period (Part 1), participants will have the option of enrolling in a 2-year open-label extension (Part 2). Part 1: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objectives of Part 1 of this study are to determine the proportion of participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores. Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of natalizumab in participants with SPMS. The secondary objectives of Part 2 of the study are to investigate long-term disability (based on clinical or participant-reported assessments) in participants with SPMS receiving natalizumab treatment for approximately 4 years and to assess change in brain volume and T2 lesion volume.

This is a prospective, multi-center, open-label study in Relapsing-remitting Multiple Sclerosis (RRMS) patients with mild to moderate depression treated with selected serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI) antidepressants over 16 weeks as add-on to fingolimod treatment. It is designed to evaluate the safety and tolerability of this combination in this patient population based on an immunomodulatory treatment with fingolimod.

The pathogenesis of MS remain elusive, however some studies have linked the disease with infection by Epstein-Barr virus; therefore the use of drugs with immunosuppressive or immunomodulating action alone may be less suitable for primary progressive MS.This study will evaluate treatment with hydroxyurea (HU) in primary progressive MS. Hydroxyurea act by inhibiting the synthesis of deoxynucleotides essential for viral transcription,HU has recently been used in combination with antiretroviral drugs in HIV and has been shown to limit immune activation and suppress viral load by both antiviral and cytostatic activities. Furthermore has been demonstrated experimentally that HU suppressed the expression of EBV. For these reasons HU could be useful in primary progressive MS with cytostatic and antiviral action , confirming the role of EBV in the pathogenesis of MS.

This study (28851) is a long-term follow-up study of subjects enrolled in ATAMS study 28063 (NCT00642902). The aim of this study is to monitor the safety and tolerability of atacicept administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS). This extension study consists of two parts. Part A will be double blind and Part B will be open label. During Part A, subjects initially randomized to atacicept will continue to receive the atacicept dose to which they have been randomized in study 28063 (ATAMS) once a week subcutaneously (under the skin). Subjects randomized to placebo in ATAMS will receive atacicept at 150 mg once a week subcutaneously during Part A. Once the results of ATAMS are available and the atacicept dose with the best benefit / risk ratio has been identified, all subjects will be switched to this dose and will continue the extension study open-label (Part B). Throughout the study, subjects and investigators will remain blinded with respect to initial and part A treatment allocation/dose.

The aims of this prospective, randomized study are: To assess the effect of clean intermittent catheterization (CIC) To investigate if MS patients will have symptom reduction (urgency, frequency, nocturia and incontinence) when using CIC in combination with anticholinergic drugs To identify at what volume of Postvoid Residual (PVR) urine, starting CIC improves bladder control and QoL To increase the evidence of CIC, and support clinical guidelines of bladder management in MS patients

To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.