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Found 6 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis SPMS. This is a Phase III, randomized, double-blind, placebo-controlled, multi-center study involving approximately 1275 participants. The study aims to provide important data on remibrutinibs effect on disability progression in SPMS and includes both a Core Part and an Extension Part for further assessment. Participants are randomly assigned to receive either remibrutinib or a matching placebo as oral film-coated tablets during the Core Part. The Core Part includes double-blind treatment, followed by an Extension Part where all participants receive open-label remibrutinib tablets. Treatment is taken orally, and the study is event-driven, continuing until required endpoints are met. During the study, participants undergo regular assessments of disability progression using the Expanded Disability Status Scale EDSS, Timed 25-Foot Walk, 9-Hole Peg Test, and Symbol Digit Modalities Test, among others. Brain imaging and safety monitoring for adverse events are performed throughout up to approximately five years. Researchers track changes in brain lesions and atrophy, and follow participants for safety and treatment effects over time.
Actively Recruiting
Researchers are studying patients who are sent to the emergency department by their general practitioners to find out how many could instead be treated in walk-in clinics. These clinics offer quick, basic medical care without appointments and can perform simple tests like blood work and X-rays. The goal is to improve patient flow and reduce emergency room overcrowding in the le-de-France region. The study observes adult patients referred to the emergency department with a letter from their general practitioner during weekdays from 9 a.m. to 8 p.m. These patients have medical or traumatic reasons for their visit and are stable when arriving and during care. Patients needing intensive hospital care or who have life-threatening conditions are not included. Participants will be monitored during their emergency department visit to assess whether their care could have been managed in a walk-in clinic. The main measure is the proportion of patients referred by general practitioners who could have been treated in such clinics. The study helps understand how emergency services can be better used and runs until August 2025.
Actively Recruiting
This research aims to better understand how pregnancy affects women with multiple sclerosis MS and related neurological conditions, including neuromyelitis optica and myelin oligodendrocyte glycoprotein antibody-related disorders. The study focuses on important questions about the use of disease-modifying drugs during pregnancy, the effects on the mothers health and disability, the childs health, breastfeeding, and pain management during delivery. It is a national, prospective, observational study conducted within the French MS cohort called Observatoire Franais de la Sclrose en Plaque OFSEP. Women with MS or related disorders who are pregnant will be followed throughout their pregnancy and for one year after giving birth. Their children will also be monitored until they reach six years of age. There is no intervention or treatment given as part of this study instead, it collects detailed information on the course of MS during pregnancy and postpartum, including any use or discontinuation of disease-modifying drugs and other pregnancy-related factors. Participants will have regular follow-ups during pregnancy and postpartum to assess their health and any treatment-related side effects. Researchers will collect data on relapses, disability progression, breastfeeding, and use of pain relief during delivery. Children born to these women will be observed for up to six years to evaluate long-term outcomes. The main outcomes measured include the number of treatment-related adverse events during pregnancy and postpartum, helping to improve knowledge for neurologists and families regarding MS and pregnancy.
Actively Recruiting
Multiple sclerosis MS is a long-lasting autoimmune disease affecting the central nervous system and is a leading cause of severe disability in young people, impacting many individuals in France. Researchers are studying the effects of ocrelizumab, an anti-CD20 monoclonal antibody, which has shown strong results in reducing disease activity in earlier trials. This study aims to compare the safety and effectiveness of giving ocrelizumab infusions once a year versus the usual every six months in adults with active MS who have already been treated for two years. Participants will receive ocrelizumab infusions either every 12 months or every 6 months. These two schedules will be compared to see if the less frequent dosing is not worse than the standard regimen in controlling the disease. The study is randomized and controlled, involving adults who have already had at least four cycles of semi-annual ocrelizumab. The goal is to see if extending the time between infusions can reduce infection risks and treatment costs without increasing disease activity. During the study, participants will have regular MRI scans to monitor for signs of MS activity, and disease symptoms will be tracked. Researchers will measure the absence of new radiological disease activity after two years as the main outcome. The study includes follow-up visits and assessments to ensure safety and effectiveness, with participants usual care continuing alongside the trial. The total study duration and detailed monitoring will help understand the impact of spacing out ocrelizumab infusions over time.
Actively Recruiting
Researchers are evaluating patients who have experienced acute ischemic stroke and were treated with clot-busting medicine thrombolysis and a procedure to remove the clot thrombectomy. Despite these treatments, about half of patients do not fully recover. The study aims to determine if certain brain imaging scores, alone or combined, can better predict patient recovery 90 days after stroke and the success of blood vessel reopening. This observational study will include 152 patients and is sponsored by Centre Hospitalier de Gonesse. The study involves observing patients who received both thrombolysis and thrombectomy after an acute ischemic stroke. There are no additional treatments or interventions given as part of the study. Instead, the researchers will analyze brain imaging and clinical data collected during routine care to assess how well the imaging scores predict recovery outcomes. Participants will be followed for about 90 days after their stroke. Researchers will collect clinical follow-up data, including the modified Rankin Scale mRS score at 90 days, to measure recovery. The main outcome is a favorable functional outcome defined as an mRS score of 0 to 2 at 90 days. The study aims to find simple and reliable tools to help doctors make better treatment decisions in the future.
Actively Recruiting
Researchers are comparing two treatments, rituximab and ocrelizumab, for patients with relapsing-remitting multiple sclerosis RRMS who have active disease. The study aims to show that rituximab is not inferior to ocrelizumab in the percentage of patients without disease activity after 2 years. This trial addresses the high cost differences between the treatments and the need to understand their relative effectiveness and safety in RRMS management. Participants receive either rituximab or ocrelizumab through infusions following a specific schedule rituximab is given as 300 mg on Day 0 and Day 15, then every 6 months ocrelizumab is given as 1000 mg on Day 0 and Day 15, then 500 mg every 6 months, up to 24 months. The study includes six follow-up visits over 2 years, aligned with routine treatment infusion times, and collects information on health status and quality of life. During the trial, participants complete health and quality of life questionnaires, and undergo clinical and MRI assessments to monitor disease activity and progression. Researchers measure outcomes like relapse rates, disability progression, MRI lesions, quality of life scores, and safety events. The study lasts 2 years, with visits planned at treatment initiation, 15 days later, and every 6 months thereafter to closely track participants health and treatment effects.