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

This study is a randomized controlled trial (RCT) that compares the effects of two different 12-month aerobic walking exercise programs on cognitive processing speed (CPS), brain MRI, and other functional outcomes in 32 adults with multiple sclerosis (MS) who are able to walk without an assistive device but demonstrate slowed CPS. Participants (N=32) will initially undergo screening via telephone, and after satisfying relevant inclusion/exclusion criteria, will provide informed consent, followed by a baseline assessment of CPS remotely via a HIPAA-compliant virtual platform (i.e., Zoom for Healthcare). This assessment will also serve as a screen for ensuring impaired CPS. Following this virtual session, participants will come into Kessler Foundation (KF) and complete a 3-hour baseline assessment (T0) that includes a relatively short battery of neuropsychological tests, a 40-minute MRI scan, tests of walking function, a short questionnaire packet, followed by cardiopulmonary exercise testing on a motor-driven treadmill. Following T0, participants will be randomly assigned into one of the two aerobic walking ET programs that are remotely-delivered and supported by KF research assistants. As the conditions are delivered and supported remotely by KF personnel, the exercise itself takes place in the home/community setting. Both conditions involve behavior coaching via Zoom for Healthcare. The experimental condition involves high-frequency, high-intensity aerobic walking ET that exceeds the published guidelines for physical activity for adults with MS (GEMS+). GEMS + initially involves 10 minutes of moderate intensity aerobic walking exercise for 3 days per week and progresses to upwards of 40 minutes of vigorous intensity aerobic walking exercise for 5 days per week by month 12. The comparison condition involves mild-to-moderate aerobic walking exercise training that approximates published guidelines (GEMS). GEMS initially involves 10 minutes of light intensity aerobic walking exercise for 2 days per week and progresses up to 30 minutes of moderate intensity aerobic walking exercise for 3 days per week. Both conditions further will be monitored based on Fitbit-measured steps per exercise session. Of note, the sample size will be enrolled using 2 overlapping waves (Wave 1 = 14 participants, Wave 2 = 18 participants), 3 months apart. Participants will return to KF at the mid-point (i.e., T6) and end-point (i.e., T12) of the 12-month intervention period to complete the same assessments as T0. The T6 and T12 outcomes will be administered by treatment-blinded research assistants.

FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has begun. It is unclear if, in the relapsing phase, there is an advantage of early aggressive therapy with respect to preventing long-term disability. The infectious risks and other complications associated with higher-efficacy treatments highlight the need to quantify their effectiveness in preventing disability. The TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial is a pragmatic, randomized controlled trial that has two primary aims: 1) to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an "early aggressive" therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and 2) to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability.

The DELIVER-MS study seeks to answer the question: Does early treatment with highly effective DMT improve the prognosis for people with MS? This is an area of significant controversy and no data currently exist to guide treatment choices for patients and clinicians. The study results will help guide overall treatment philosophy and will be applicable not only to a wide range of existing therapies but also to new therapies, meeting a significant unmet need in patient decision making and aiding the decision for medication approval by third parties.

The purpose of this study is to determine the safety and tolerability of the intranodal administration of autologous monocyte-derived dendritic cells tolerised with Vitamin-D3 and pulsed with myelin peptides (tolDC-VitD3) in multiple sclerosis patients . To select the most appropriate regime for the development of future therapeutic trials. To evaluate the preliminary proof of concept by clinical and/or radiological activity and immunological markers.

The primary goal of this study is to assess the efficacy of bazedoxifene (BZA) as remyelinating agent in patients with relapsing-remitting multiple sclerosis (RRMS). The investigators will utilize electrophysiologic techniques and magnetic resonance imaging to quantify the effect of treatment in 50 women over the course of 6 months. Participants may remain on their standard disease modifying treatment during the course of the trial but may not concurrently participate in any other investigational new drug research study.

This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.

This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be followed for 72 months after randomization (Day 0, Visit 0).

The purpose of the study is to describe the safety profile of fingolimod in the Taiwanese multiple sclerosis population. This study aims to collect the safety data in patients newly initiated on fingolimod for one year.

The aim of this study is to identify whether it is possible to safely discontinue treatment in relapsing-onset MS patients who have shown no evidence of active inflammation in the years prior to inclusion clinically and/or radiologically. The secondary objectives address the questions whether the discontinuation of first-line treatment has an effect on disability progression and whether the discontinuation of first-line treatment improves the quality of life for the patient. Furthermore, blood collections will be included to assess whether it is possible to retrospectively predict possible return of inflammatory activity with biomarkers such as neurofilament light (NFL) or patient characteristics such as disease activity prior to disease modifying therapy (DMT). In case of emerging disease activity after the cessation of therapy we will assess if reinitiation will lead to NEDA again, and if there are long-term consequences. If possible, post-hoc analysis are performed for the different types of treatment compounds.

The DanNORMS study is phase 3 non-inferiority clinical trial examining whether treatment of active multiple sclerosis with rituximab is non-inferior to ocrelizumab regarding efficacy and safety.