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AI · Multiple sclerosis

Намерени 53 изпитвания за "Multiple sclerosis" Стр. 2 от 3

Набира участници Фаза 4

Effects of CLADribine tablets on the Immune Synapse, in Relapsing Multiple Sclerosis (RMS) patients_CLADIS.

Multiple Sclerosis

Trial status: Authorised Change in the expression of the co-stimulatory and adhesion molecules comprising the immune synapse in the relevant subpopulations of the adaptive and innate immune system, at 6- months of treatment, relative to baseline, Change in the ARR at year 1, relative to the 12-month pre-treatment period, Change in EDSS at the end of year 1, compared to baseline, Change in T25FW at the end of year 1, compared to baseline, Change in 9HPT at the end of year 1, compared to baseline, Number of T1 lesions (Gd+ and black holes) at the end of year 1, compared to baseline, Number of T2 lesions (total, new/enlarging) at the end of year 1, compared to baseline, Number CUA at the end of year 1, compared to baseline, Proportion of patients with NEDA-3 at the end of year 1, Proportion of patients with MEDA-3 at the end of year 1, Correlation of changes in the expression of Immune Synapse molecules in the immune cell populations of interest, with clinical outcomes at the end of year 1, Correlation of changes in the expression of Immune Synapse molecules in the immune cell populations of interest, with MRI outcomes at the end of year 1 Change in the expression of the co-stimulatory and adhesion molecules comprising the immune synapse in the relevant subpopulations of the adaptive and innate immune system, at 12- months of treatment, relative to baseline

Начало: 17.04.2026 Възраст: 18–64 г.

Greece Aristotle University Of Thessaloniki 2025-521910-24-00

Набира участници Фаза 3

Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis

Multiple Sclerosis

This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment. The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months. The number of scheduled visits (Parts A and B) will be 17 or 11 for participants receiving frexalimab SC or IV, respectively, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.

Начало: 14.01.2026 Край: 30.11.2028 Възраст: 18–60 г.

Belgium, United States Sanofi NCT07325292

Набира участници

Does Position Influence the Diagnosis of Detrusor Overactivity in a Neurological Population

Urodynamic Exam Neurologic Disorder

ICS (International Continence Society) recommendations published in 2017 recommend performing urodynamic examinations in the sitting or standing position. These recommendations are based on a review of the literature published in 2008, which has several limitations: heterogeneous populations, old and non-harmonized techniques, and very few neurological patients. It seems appropriate to focus on neurological patients and to examine the influence of position on the detection of detrusor overactivity in these patients. The point here is to reexamine the ICS recommendations, which are not designed for neurological patients. Indeed, many patients suffering from Multiple Sclerosis (MS) or Parkinson's disease are unable to sit or stand for the duration of the urodynamic examination. The investigators would like to assess whether exploring sphincter disorders in the supine position is still interpretable. This would enable us to define ICS good practice recommendations for a neurological population.

Начало: 02.04.2024 Край: 02.04.2027 Възраст: от 18 г.

France Assistance Publique - Hôpitaux de Paris NCT05949567

Набира участници Фаза 3

Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

Multiple Sclerosis

The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: * This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end. * The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. * If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months.

Начало: 27.12.2023 Край: 24.03.2028 Възраст: 18–60 г. Лечение

Argentina, Australia, Belgium +23 Sanofi NCT06141486

Набира участници

Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Multiple Sclerosis

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries). The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

Начало: 27.10.2023 Край: 06.07.2032

Australia, Germany, Ireland +3 Biogen NCT05658497

Набира участници

Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System

Central Nervous System Disease Multiple Sclerosis

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). This study will compare tests performed on both healthy volunteers and individuals who have signs or symptoms of immune-related damage to their CNS. This study will include two groups of subjects at least 12 years old. Subjects will either have symptoms of immune-related CNS damage, or will be healthy volunteers selected for comparison purposes. Study participants will visit the NIH Clinical Center on an outpatient basis for an initial evaluation visit. During the visit, patients will provide a comprehensive medical history and undergo a neurological examination, and will provide blood samples for research purposes. The healthy volunteers will be asked to schedule a return visit for a magnetic resonance imaging (MRI) procedure, and may be asked to undergo other tests requested by the study researchers on an as-needed basis. The group of patients with symptoms of immune-related CNS damage will be asked to undergo a series of tests, including the following: * MRI procedures, with a minimum of three brain MRIs and one spinal cord MRI taken approximately 4 weeks apart * A diagnostic lumbar puncture, performed on an outpatient basis * Tests of brain and vision activity * Additional blood and tissue samples Patients with symptoms of immune-related CNS damage may be offered the opportunity to participate in additional followup tests with NIH researchers.

Начало: 01.10.2008 Възраст: 1–99 г.

United States National Institute of Allergy and Infectious Diseases ( NCT00794352

Предстои набиране

Effects of Sleep Quality on Functional and Cognitive Outcomes in Multiple Sclerosi

Multiple Sclerosis

The goal of this observational study is to investigate the effects of sleep quality on cognitive flexibility, physical activity level, body awareness, and reaction time in individuals with Multiple Sclerosis. The main question it aims to answer is: Does sleep quality influence cognitive flexibility, physical activity level, body awareness, and reaction time in individuals with Multiple Sclerosis? Researchers will compare individuals with good and poor sleep quality to determine whether differences in sleep quality result in variations in cognitive and physical performance outcomes. Participants will complete standardized assessments of sleep quality, cognitive flexibility, physical activity, and body awareness, and will perform a computer-based reaction time test. In addition, participants will wear a wearable activity tracker for 7 days to objectively measure physical activity levels.

Начало: 01.05.2026 Край: 01.08.2026 Възраст: 18–65 г.

Turkey (Türkiye) Büşra Seçkinoğulları Korkusuz NCT07536503

Предстои набиране

Multicenter Prospective Study Analyzing the Occurrence of Multiple Sclerosis Relapses Without Radiological Evidence: Myth or Reality?

Multiple Sclerosis RRMS Multiple Sclerosis (MS) - Relapsing-remitting

The MYTH-MS study is a multicenter prospective study investigating the occurrence of clinical relapses in patients with relapsing-remitting multiple sclerosis (RRMS) in the absence of radiological activity on MRI. While MS relapses are typically associated with gadolinium-enhancing lesions on MRI, some patients present with acute neurological symptoms without radiological correlates, referred to as acute clinical events with stable MRI (ACES). The frequency, mechanisms, and clinical relevance of these events remain unclear due to limitations in previous studies. The primary objective is to determine the proportion of RRMS patients experiencing a relapse without gadolinium-enhancing lesions on early brain and spinal MRI. Secondary objectives include identifying clinical, radiological, biological, and psychological predictors, assessing neurologists' diagnostic accuracy, and evaluating clinical outcomes such as disability, cognition, and quality of life over a 6-month follow-up. A total of 136 patients with recent neurological exacerbations will be included. Each participant will undergo clinical assessment, cognitive and psychological evaluation, and early MRI, with follow-up at 6 months. An ancillary study will explore blood biomarkers (NfL, GFAP, and circulating DNA) to help differentiate true inflammatory relapses from ACES. This study aims to improve the understanding and diagnosis of MS exacerbations and to optimize patient management by reducing misdiagnosis and unnecessary treatments.

Начало: 01.09.2026 Край: 01.05.2030 Възраст: 18–70 г.

France University Hospital, Strasbourg, France NCT07545889

Предстои набиране

Exercise Training for People With Advanced Multiple Sclerosis

Multiple Sclerosis

The goal of this interventional study is to test the feasibility of 12 weeks of aerobic exercise for people with advanced multiple sclerosis (i.e., wheelchair users). The main questions it aims to answer are: * Is the exercise intervention feasible in terms of study processes, resources, management, safety, and acceptability? * Can the intervention improve aerobic fitness, function in daily life, cognition, symptoms of fatigue and pain, and sensation? * What are participants' experiences of taking part in the exercise intervention? Participants will take part in moderate-intensity aerobic exercise twice a week for 12 weeks in a supervised research setting. Outcomes will be measured at baseline (0 weeks), mid-intervention (6 weeks), post-intervention (12 weeks), and 12-weeks after the intervention (24 weeks). The outcomes include feasibility measures, aerobic fitness, function in daily life, cognition, symptoms of fatigue and pain, sensation, and participant experiences of taking part in the exercise intervention.

Начало: 01.05.2026 Край: 01.06.2027 Възраст: от 18 г.

University of Ottawa NCT07546721

Предстои набиране Ранна Фаза 1

An Open-Label, Single-Arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of CD20 Monoclonal Antibody Combined With NK042 Cell Injection in the Treatment of Multiple Sclerosis (MS).

Multiple Sclerosis

This is an Open-Label, Single-Arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of CD20 Monoclonal Antibody Combined with NK042 Cell Injection in the Treatment of Multiple Sclerosis (MS).

Начало: 01.05.2026 Край: 30.12.2028 Възраст: 18–65 г.

The Affiliated Hospital of Xuzhou Medical University NCT07546110

Предстои набиране Фаза 2

A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)

Relapsing-remitting Multiple Sclerosis

The main purpose of this study is to evaluate the pharmacokinetics (PK) of ocrelizumab administered subcutaneously (SC) in children and adolescents aged 10 to \

Начало: 01.08.2026 Край: 01.08.2031 Възраст: 10–17 г.

Hoffmann-La Roche NCT07503340

Активно (без набиране) Фаза 1

A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis

Multiple Sclerosis

This study aims to explore the safety, tolerability, cellular kinetics, and pharmacodynamics of P-CD19CD20-ALLO1 in participants with progressive multiple sclerosis (PMS) and relapsing multiple sclerosis (RMS).

Начало: 15.10.2025 Край: 31.08.2032 Възраст: 18–60 г.

United States Genentech, Inc. NCT07008378

Активно (без набиране) Фаза 3

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

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.

Начало: 18.10.2019 Край: 20.05.2027 Възраст: 10–18 г. Лечение

Argentina, Australia, Belgium +18 Biogen NCT03958877

Активно (без набиране)

Improving Cognitive Recovery in Multiple Sclerosis

Multiple Sclerosis

This study aims to find out whether an adapted version of an existing cognitive rehabilitation program, CIRCuiTS (https://www.circuitstherapyinfo.com), can be used to improve everyday thinking skills for people with Multiple Sclerosis (MS). People living with MS have worked with the study's researchers to adapt CIRCuiTS to meet their needs. They shared the thinking challenges they experience and suggested changes to the program's content and how it is delivered. This study will test whether this adapted version can be delivered practically to people with MS in a trial setting and explore its potential benefits. The findings will help plan a larger trial testing how effective CIRCuiTS is in helping people with MS. Twenty-four people with MS will take part in this pilot trial. Each person will be randomly assigned to start the program either right away or after a 13-week wait. The therapy program involves up to 36 hours of therapist-led and independent sessions over 12 weeks in which the participant builds thinking skills through developing personal strategies for carrying out digital versions of tasks they find challenging. The practicality of delivering the program to people with MS will be judged based on whether problems arise in the trial, such as not being able to recruit enough people or participants not liking it. To explore its potential benefits, the study will check for improvements in progress toward personal goals, thinking abilities, emotional well-being, chronic tiredness, and daily living skills after the therapy. If delivering CIRCuiTS to people with MS is found to be both practical and acceptable to participants, the findings of this trial will be used to design a larger-scale trial of its effectiveness. Ultimately, the goal of this project is to improve the quality of life of people living with cognitive difficulties related to MS.

Начало: 17.07.2025 Край: 15.09.2026 Възраст: от 18 г.

United Kingdom King's College London NCT06877273

Активно (без набиране) Фаза 3

Randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to teriflunomide in adult participants with relapsing forms of multiple sclerosis

multiple sclerosis

Trial status: Authorised Time to onset of composite confirmed disability worsening (cCDW), Time to onset of cCDW, confirmed over 3 months, Time to onset of individual components of the composite, confirmed over 3-months or 6- months, Time to onset of confirmed disability improvement (CDI), Progression independent of relapse activity defined as the time to onset of 6-month cCDW, Total number of new and/or enlarging T2-hyperintense lesions as detected by MRI, Total number of new Gd-enhancing T1-hyperintense lesions per scan as detected by MRI, Percent change in brain volume loss as detected by brain MRI scans at the EOS compared to Month 6, Change in cognitive function at the EOS compared to baseline as assessed by the symbol digit modalities test (SDMT), Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time, Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue MS-8 over time, Adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, safety scales, and potentially clinically significant abnormality (PCSAs) in laboratory tests, ECG, and vital signs during the study period, Antidrug antibodies (ADAs) over time, Change from baseline in plasma neurofilament light chain (NfL) levels over time, Frexalimab plasma concentration over time Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses

Начало: 26.04.2024 Възраст: 18–64 г.

Austria, Belgium, Bulgaria +15 Sanofi-Aventis Recherche & Developpement 2023-504358-36-00

Активно (без набиране) Фаза 3

Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis

Multiple Sclerosis (MS)

Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis

Начало: 05.10.2021 Край: 06.03.2031 Възраст: 10–17 г. Лечение

Argentina, Australia, Belgium +20 Novartis Pharmaceuticals NCT04926818

Активно (без набиране) Фаза 3

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis

Multiple Sclerosis, Primary Progressive

A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (and placebo) or intravenous (IV) ocrelizumab (and placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). 985 participants were enrolled and recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

Начало: 26.10.2020 Край: 21.07.2027 Възраст: 18–65 г. Лечение

Argentina, Australia, Brazil +22 Hoffmann-La Roche NCT04544449

Активно (без набиране)

Nursing Students' Brain/MS Immersive Three-Dimensional Learning Activity

Multiple Sclerosis

This study compared two educational methods. Participants were assigned to participate in a 360-degree experience or a slideshow presentation. The 360-degree video group included a brain and MS program. The comparison group was given a slideshow presentation with the same information. Participants viewed the 360-degree program or the slideshow presentation only once. The online-based materials consisted of a demographic form (age, gender, race and ethnicity, and name of school), knowledge questionnaires, and an experiential learning scale. Pre-intervention, participants were asked about demographic information, whether they had previous experience with MS, the science classes they completed in high school and college, and their knowledge of the human brain and MS pathophysiology. At both pre- and post-intervention, participants completed the Multiple Sclerosis Magnetic Resonance Imaging Knowledge Questionnaire (MSMRIKQ) and the Multiple Sclerosis Knowledge Questionnaire (MSKQ). At post-intervention, participants completed a lesson experiential questionnaire about their experience viewing either the 360-degree video or the slideshow presentation. Permission to use the three instruments was obtained from their respective copyright holders.

Начало: 01.07.2020 Край: 31.12.2026 Възраст: от 18 г.

United States Hunter College of City University of New York NCT07538063

Активно (без набиране) Фаза 3

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

Multiple Sclerosis, Primary Progressive

This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study will consist of the following phases: screening, double-blind treatment, an optional post-double-progression ocrelizumab (PDP OCR) treatment, follow-up 1 (FU1), an optional open-label extension (OLE), and follow-up 2 (FU2).

Начало: 12.08.2019 Край: 19.01.2028 Възраст: 18–65 г. Лечение

Australia, Belgium, Bulgaria +19 Hoffmann-La Roche NCT04035005

Активно (без набиране) Фаза 3

Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

Multiple Sclerosis

To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)

Начало: 26.07.2013 Край: 18.02.2030 Възраст: 10–17 г. Лечение

Australia, Brazil, Bulgaria +21 Novartis Pharmaceuticals NCT01892722

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