Multiple sclerosis clinical trials, in English

Inflammatory or degenerative diseases of the brain and spinal cord, such as multiple sclerosis, may be related to problems with an individual s immune system. However, more information is needed on the ways in which the cells of the immune system interact with the central nervous system (CNS).

NCT00794352 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.

NCT02649985 · Official ClinicalTrials.gov record · Brigham and Women's Hospital

This is a multi-center prospective rater-masked (blinded) randomly assigned 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). you would be randomly assigned at a 1 to 1 (1:1) ratio.

NCT04047628 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

CLUE is a prospective study to assess structural and functional changes of the brain, spinal cord, and optic nerve, as well as the inflammatory environment in patients with neuroinflammatory and demyelinating diseases. Participants will receive magnetic resonance (MR) techniques including DIR, DKI, QSM, Rs-fMRI, conventional sequences (T1WI/T2WI/FLAIR), and the MR metabolic SPICE sequence, and will be followed up for one year using 3T MRI.

NCT04106830 · Official ClinicalTrials.gov record · Beijing Tiantan Hospital

The investigators intend to examine the effects of ocrelizumab use in African American multiple sclerosis disease course compared to Caucasian disease course utilizing imaging measures with magnetic resonance imaging (MRI) and optical coherence tomography angiography (OCT-A)..

NCT04458688 · Official ClinicalTrials.gov record · Wayne State University

The goal is to assess the safety and effectiveness of home ocrelizumab infusion.

NCT04650321 · Official ClinicalTrials.gov record · University of Colorado, Denver

This study aims to develop and validate a sensitive and non-invasive eye-tracking software application. This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by MS and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests.

NCT05061953 · Official ClinicalTrials.gov record · Innodem Neurosciences

This is an watch-and-measure (no experimental treatment required), non-treatment, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany. Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to four years.

NCT05344469 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

The Kesimpta Pregnancy Registry is an watch-and-measure (no experimental treatment required), exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS.

NCT05634967 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

The goal of this randomly assigned clinical trial is to compare relapse remitting multiple sclerosis (RRMS) patients treated by ocrelizumab or by rituximab followed for 2 years. The main question it aims to answer is : • to demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the % of patients without disease activity at 2 years.

NCT05758831 · Official ClinicalTrials.gov record · Rennes University Hospital

This non-treatment study will compare the effect of Ofatumumab treatment between patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in a real-world setting in Portugal.

NCT05809986 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

Rationale: Ocrelizumab is widely and effectively used to treat relapsing multiple sclerosis (RMS). Phase II studies and data from large patient cohorts indicate that rituximab, another anti-CD20 monoclonal antibody, is probably equally effective and safe as ocrelizumab in the treatment of RMS.

NCT05834855 · Official ClinicalTrials.gov record · Amsterdam UMC, location VUmc

This is a neither you nor the study doctors know who gets the real treatment, randomly assigned, active-controlled, parallel group, Phase 1/3 study to compare how well it works, PK, PD and overall safety of CT-P53 with Ocrevus in patients with Relapsing-remitting Multiple Sclerosis.

NCT05906992 · Official ClinicalTrials.gov record · Celltrion

Several prospective monocentric cohorts of between 250 and 1000 patients have been set up in order to characterize more precisely the evolution of the disease. Nevertheless, due to an initial recruitment carried out in the years 2000-2010, they do not constitute a faithful representation of the patients followed in clinical routine, in particular in terms of distribution of treatments.

NCT05962177 · Official ClinicalTrials.gov record · University Hospital, Montpellier

The goal of this clinical trial is to evaluate if combining a medication that can help improve walking in people with multiple sclerosis (MS) with a physical therapy program is better for improving walking than either treatment alone. The main questions this study will answer are: * Does combining dalfampridine with physical therapy improve mobility more than physical therapy without concurrent dalfampridine?

NCT06136728 · Official ClinicalTrials.gov record · MGH Institute of Health Professions

The study is an watch-and-measure (no experimental treatment required) retrospective cohort study using longitudinal secondary data. Pregnant women with MS are assessed for exposure to Kesimpta and other MS disease modifying drugs (MSDMD) and followed up for adverse pregnancy and infant outcomes.

NCT06156683 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

To study whether highly effective therapies can halt disease progression in people with multiple sclerosis by modulating the peripheral myeloid landscape.

NCT06267781 · Official ClinicalTrials.gov record · IRCCS San Raffaele

The goal of the study is to learn about treating older people with multiple sclerosis (MS) with metformin. Metformin may be used as a single therapy or as an add-on therapy.

NCT06463743 · Official ClinicalTrials.gov record · State University of New York at Buffalo

This study is a single-country, non-treatment, multicenter, watch-and-measure (no experimental treatment required) study, mainly based on primary data collection to assess the effect of ofatumumab on clinical parameters of Multiple Sclerosis (MS) in a routine medical care setting, as compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS, which includes glatiramer acetate, interferons, teriflunomide, or dimethyl fumarate)

NCT06486779 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

A multi-center pilot study to evaluate safety and how well it works of ozanimod as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.

NCT06529406 · Official ClinicalTrials.gov record · University of Colorado, Denver

ROS-MS is a clinical pharmacological substudy to the OVERLORD-MS study (NCT04578639), designed to examine the possibilities of personalized treatment with rituximab and ocrelizumab in patients with relapsing-remitting multiple sclerosis.

NCT06663111 · Official ClinicalTrials.gov record · Haukeland University Hospital

The study will measure the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the whether it is safe and how hard side effects are to live with of ocrelizumab. From Protocol Version 6 onwards, treatment within this study will be limited to the currently approved doses of ocrelizumab, 600 milligrams (mg), intravenous (IV) infusion or 920 mg, subcutaneous (SC) injection.

NCT06675955 · Official ClinicalTrials.gov record · Hoffmann-La Roche

The exploratory ELIOS study aims to assess the value of novel investigational Eye Movement Biomarkers (EMBs) in tracking disease-related changes among a real-world cohort of Canadian patients with active RRMS, within the context of disease-modifying treatment (i.e., ofatumumab). To that end, the study will use the patented investigational, Eye Tracking Neurological Assessment (ETNA-ProgMS) SaMD (v1.0.11 or later), which has not yet received Health Canada approval, to reliably and accurately track eye movements with precision.

NCT06733922 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

The main purpose of the study is to evaluate participant satisfaction after administration of ocrelizumab subcutaneously (SC) after 12 months using the therapy administration satisfaction questionnaire subcutaneous (TASQ-SC).

NCT06780150 · Official ClinicalTrials.gov record · Hoffmann-La Roche

The purpose of this Phase 3b study is to assess the how well it works, whether it is safe and how hard side effects are to live with of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).

NCT06846281 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

This study wants to assess the ability of the home-based intervention, HOBSCOTCH-MS to improve the quality of life and cognitive function in Service Members, Veterans and civilians who have multiple sclerosis with cognitive and memory problems (MS participants). This study will also assess the ability of the HOBSCOTCH-MS program to improve quality of life in caregivers of patients with multiple sclerosis and to reduce caregiver burden.

NCT06951919 · Official ClinicalTrials.gov record · Dartmouth-Hitchcock Medical Center

This study wants to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-dummy treatment (placebo).

NCT07002034 · Official ClinicalTrials.gov record · Reunion Neuroscience Inc

The goal of this clinical trial is to investigate motor responses in healthy subjects and patients with movement disorders, brain and spinal cord injury, neuromuscular diseases, or cardiovascular diseases. This study aims to measure the effectiveness of traditional physical activities combined with innovative interventions such as cryotherapy, ultrasound therapy, laser therapy, transcranial magnetic stimulation (TMS), and transcranial direct current stimulation (tDCS).

NCT07066137 · Official ClinicalTrials.gov record · IRCCS Centro Neurolesi Bonino Pulejo

Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, multicenter study to measure the how well it works and safety of orelabrutinib compared with dummy treatment (placebo) in patients with PPMS.

NCT07067463 · Official ClinicalTrials.gov record · Zenas BioPharma (USA), LLC

Study the impact of rTMS on walking ability in people with Multiple Sclerosis (MS) induced spastic paraparesis and moderate walking disability.

NCT07159789 · Official ClinicalTrials.gov record · Clinique Neuro-Outaouais

This open label, single arm study will measure the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and \< 18 years. This study consists of a Dose Exploration Period and an Optional Extension Period.

NCT07161258 · Official ClinicalTrials.gov record · Hoffmann-La Roche

Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost. It commonly starts during the third and fourth decades.

NCT07189325 · Official ClinicalTrials.gov record · University Hospital, Montpellier

The primary outcome measure is PIRA (progression independent of relapse activity), based primarily on clinical assessment, dichotomized as present or not. For Aim 1, the cohort, patient-derived disability status (PDDS) score, and ambulation score (self-reported) will be the primary endpoints of interest.

NCT07207148 · Official ClinicalTrials.gov record · Northwestern University

The main purpose of this study is to assess the how well it works of RO7268489 in adults with progressive multiple sclerosis (PMS) receiving ocrelizumab. After the end of the neither you nor the study doctors know who gets the real treatment period, an open-label (OL) extension may allow eligible participants to receive open-label RO7268489.

NCT07282574 · Official ClinicalTrials.gov record · Hoffmann-La Roche

Reference MRI scan is recommended 6 months after treatment onset in patients with multiple sclerosis (MS), and follow-up scans at 12 months later to monitor subclinical activity. When monitoring treatment response in patients treated with disease modifying treatments (DMTs), the measurement of new or enlarging T2/FLAIR hyperintense lesions (NELs) is the preferred MRI method supplemented by contrast-enhancing lesions (CELs) for monitoring treatment response.

NCT07292480 · Official ClinicalTrials.gov record · Centre Hospitalier Universitaire de Nīmes

Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, multicenter study to measure the how well it works and safety of orelabrutinib compared with dummy treatment (placebo) in patients with non-active Secondary Progress MS.

NCT07299019 · Official ClinicalTrials.gov record · Zenas BioPharma (USA), LLC

Spasticity is an umbrella term for impairments of muscle tone and control in people with damage to the brain and spinal cord. It is highly prevalent and results in pain, stiffness, and contribute to difficulties in activities of daily living.

NCT07303582 · Official ClinicalTrials.gov record · Oxford University Hospitals NHS Trust

The aim of this study is to compare the how well it works, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.

NCT07321093 · Official ClinicalTrials.gov record · Biocad

Multiple sclerosis (MS) is an immune-mediated disease characterized primarily by inflammatory demyelinating lesions in the central nervous system (CNS), with the white matter being predominantly affected. Its etiology remains unclear and may be associated with various factors such as genetics, environment, and viral infections .

NCT07353216 · Official ClinicalTrials.gov record · Third Affiliated Hospital, Sun Yat-Sen University

Multiple sclerosis (MS), an inflammatory, neurodegenerative disease of the central nervous system, affects around 120,000 patients in France and is the leading cause of non-traumatic disability in young adults. It affects patients' health-related quality of life (QoL) and has a significant economic impact on patients and society as a whole.

NCT07372599 · Official ClinicalTrials.gov record · University Hospital, Caen

This pilot mixed-method study will measure the feasibility, preliminary how well it works, and user experience of a home-based wearable Focal Vibration Therapy (FVT) intervention for improving upper extremity (UEx) function in people with multiple sclerosis (MS). Fifteen adults with relapsing-remitting MS (PRMS) and self-reported UEx impairments will participate in a 4-week FVT program using MyovoltTM wearable FVT devices applied to arm muscles.

NCT07376772 · Official ClinicalTrials.gov record · University of Florida

The proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.

NCT07389590 · Official ClinicalTrials.gov record · Johns Hopkins University

The goal of this clinical trial is to evaluate if the study drug will reduce brain and retinal atrophy by reducing inflammation and subsequently slowing neurodegeneration in people with Multiple Sclerosis. The main outcome for the trial is change in normalized brain parenchymal volume (nBPV), measured by magnetic resonance imaging (MRI).

NCT07497399 · Official ClinicalTrials.gov record · Johns Hopkins University

The main purpose of this study is to assess whether hyperpolarized carbon imaging in relapsing remitting multiple sclerosis (MS) patients can be used to predict response to anti-CD20 disease modifying therapy. Study procedures will include magnetic resonance imaging (MRI) assessments with a hyperpolarized pyruvate sequence, clinical assessment as well as blood markers of disease progression.

NCT07510607 · Official ClinicalTrials.gov record · Ari Green

This study wants to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differentiation 20 (aCD20) therapy approved for RMS (ofatumumab SC, ublituximab-xiiy intravenous \[IV\], ocrelizumab IV) or PPMS (ocrelizumab IV).

NCT07609719 · Official ClinicalTrials.gov record · Genentech, Inc.

This real-life study aims to describe IgG levels after switching from ocrelizumab 600 mg IV every 6 to 8 months in Patients with Multiple Sclerosis (PwMS) to ofatumumab 20 mg SC every month and showing a decreasing level of IgG during treatment by ocrelizumab in real life practice in France over 24 months of follow-up. The primary objective is therefore to determine if the downward trend of IgG observed during ocrelizumab treatment is modified after a switch to ofatumumab, in PwMS treated during at least 18 months of ocrelizumab in real life practice, over 24 months of follow-up.

NCT07625800 · Official ClinicalTrials.gov record · University Hospital, Lille

Ocrevus Zunovo implementation, feasibility, acceptability, patient satisfaction, treatment persistence, and impact on MS disease outcomes will be analyzed in this mixed methods study. This study will incorporate clinical data and questionnaire results from MS patients who take Ocrevus Zunovo as well as qualitative interviews with MS patients, family members, and other individuals involved in Ocrevus Zunovo treatment.

NCT07710105 · Official ClinicalTrials.gov record · Northwestern University

By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic brain injury.

NCT07738978 · Official ClinicalTrials.gov record · Louis Stokes VA Medical Center

REDEFINE-MS is a research study for people with relapsing multiple sclerosis (MS) who are participating in the RESHAPE-MS trial. The study aims to better understand how remibrutinib affects inflammation in the brain and spinal cord by using PET imaging, MRI scans, blood samples, and cerebrospinal fluid (CSF) samples collected before treatment and again six months later.

NCT07758270 · Official ClinicalTrials.gov record · Washington University School of Medicine

This watch-and-measure (no experimental treatment required) cross-sectional study aims to determine chronic pain phenotypes in individuals with multiple sclerosis (MS) and to investigate the clinical characteristics associated with different pain phenotypes. Participants with MS and chronic pain will undergo a comprehensive clinical assessment to identify nociceptive, neuropathic, nociplastic, and mixed pain phenotypes.

NCT07766213 · Official ClinicalTrials.gov record · Kutahya Health Sciences University

This study aims to generate real-world evidence on the clinical effectiveness and economic burden of ofatumumab (OMB) versus ocrelizumab (OCR) in patients diagnosed with multiple sclerosis (MS) in the United States (US). Clinical effectiveness will be assessed using annualized relapse rate (ARR), while economic burden will be assessed using healthcare resource utilization (HCRU) and healthcare costs (HCC).

NCT07779460 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

This study investigates objective methods to measure and monitor fatigue in patients with post-COVID-19 condition (long COVID) and multiple sclerosis (MS), and includes a group of healthy volunteers for comparison. Fatigue is a common and debilitating symptom of both conditions, but current assessment methods rely mainly on questionnaires, which can be limited by subjectivity and recall bias.

NCT07783074 · Official ClinicalTrials.gov record · Liliana Barrios

The aim of this study is to comparatively examine the effect of aerobic fitness levels on walking and balance performance, sensory dual-task (proprioceptive and vestibular) performance, balance confidence, and fatigue levels in individuals diagnosed with MS. Research hypotheses H1: MS patients with high aerobic fitness exhibit superior walking speed and balance performance compared to MS patients with low aerobic fitness.

NCT07815990 · Official ClinicalTrials.gov record · Suleyman Demirel University

The main purpose of the study is to assess patient-reported satisfaction with subcutaneous (s.c.) ocrelizumab administration in participants with relapsing-remitting multiple sclerosis (RRMS) who are treatment-who have not tried this kind of treatment before, switching from intravenous (i.v.) ocrelizumab to s.c. ocrelizumab, or switching from a prior disease-modifying therapy (DMT) to s.c.

NCT07827586 · Official ClinicalTrials.gov record · Hoffmann-La Roche

The goal of this Phase 2 clinical trial is to investigate the whether it is safe and how hard side effects are to live with of SUN-627 in men and women aged 18-70 years old with a diagnosis of non-active SPMS/PPMS.

NCT07840326 · Official ClinicalTrials.gov record · Sundance Biosciences, Inc.

This study will compare starting Ocrevus Zunovo soon after an active episode of relapsing multiple sclerosis (MS) with starting it later. Researchers want to learn whether starting treatment sooner reduces the number of MS relapses over 18 months.

NCT07878923 · Official ClinicalTrials.gov record · Oklahoma Medical Research Foundation

Multiple sclerosis (MS) is a condition in which the immune system damages the brain and spinal cord. Treatments called disease-modifying therapies can reduce inflammation and disease activity.

NCT07899502 · Official ClinicalTrials.gov record · Imperial College London

This study is conducted to: * Investigate the effect of virtual reality based training on balance and risk of falling. * Investigate the effect of virtual reality based training on gait.

NCT07918339 · Official ClinicalTrials.gov record · Cairo University

This study will test whether a treadmill-based virtual reality walking program is safe, practical, and helpful for people with multiple sclerosis (MS). Participants will complete a 6-week training program and wear smart socks that measure how they walk before, during, and after the program.

NCT07927439 · Official ClinicalTrials.gov record · Shepherd Center, Atlanta GA