View clinical trials related to Neuromyelitis Optica.
Filter by:The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab in pediatric participants with Neuromyelitis Optica Spectrum Disorder (NMOSD).
This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder.
This study is being conducted to investigate risk factors for disability progression in Multiple Sclerosis and related disorders (MSRD). The primary goal is to assess whether combining information from visual assessment, blood markers, as well as historical and ongoing longitudinal MRIs of the brain, orbit (the part of the skull where eyes are located), and/or spinal cord can predict changes in quantitative disability measures related to MSRD and neurological disease.
This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.
Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Belimumab (Benlysta ®) is a human immunoglobulin G1λ monoclonal antibody that inhibits B-cell survival and differentiation by neutralizing soluble B lymphocyte stimulator. Belimumab may benefit some patients with NMOSD due to the important role of B cells in the pathogenesis of NMOSD. Clincial trials may be needed to observe its efficacy and safety.
Central nervous system (CNS) idiopathic inflammatory demyelinating diseases (IDD) are mainly diseases caused by autoimmune factors that result in CNS demyelination damage and loss. It tends to accumulate in the brain, spinal cord and optic nerves. Multiple sclerosis (MS), clinically isolated syndrome (CIS), neuromyelitis optica spectrum disorder (NMOSD), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and acute disseminated encephalomyelitis (ADEM) are all common IDDs of the CNS. Besides, primary angiitis of the central nervous system (PACNS), autoimmune glial fibrillary acidic protein astrocytopathy (GFAP-A), etc. may also be included because they are important differential diagnoses. This study will establish a large prospective cohort study database of Chinese IDD, which will record detailed electronic information on IDD patients, including demographic and socioeconomic data, medical history, clinical information, medication, and relevant examination results. The long-term observational study will be used to understand the natural history of disease, disability progression rates, imaging and biological indicators, long-term treatment approaches and prognosis of Chinese patients with IDD, to find predictive markers for IDD progression and prognosis, and to identify factors that influence the treatment and prognosis of patients with IDD.
The objectives of this phase Ib study are to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenic profiles of B001 in subjects with aquaporin-4 antibody (AQP4-IgG) positive NMOSD.
Background: An assessment by paediatric neurologists specializing in demyelinating conditions brought attention to the rapid weight change seen among patients recently diagnosed with, and receiving therapy for, neuromyelitis optica spectrum disorder (NMOSD) and multiple sclerosis (MS). An overview of the current literature pinpointed weight change as a concern, and identified fatigue and fear as limiting factors for participation in physical activity, with BMI trajectories in this population significantly higher compared to healthy peers. A look at current patient data highlighted extreme NMOSD cases where some patients' weight doubled in two years. There is currently no available research that addresses weight change and management in paediatric MS or NMOSD patients, but there is research to highlight the importance of maintaining health behaviours. The aim of this research is to co-develop a comprehensive lifestyle weight management program for this cohort. Methods: Unpinned by the Medical Research Council guidance for developing complex interventions, this research will involve a fourfold approach. It will build on a previously completed systematic review, and a secondary data analysis of current clinical data regarding weight changes in these populations. Semi-structured interviews will be conducted with patients, parents and clinicians in order to obtain qualitative data regarding the collective perspectives of nutrition, weight change and overall health. A list of factors will be identified and presented in a logic model. A program will then be designed, informed by previously gathered information and will be reviewed by a group of stakeholders via stakeholder meetings. This will output a program design, implementation and evaluation plan which will then be evaluated for feasibility. Recruitment, participation, implementation and adherence to the program will be tested. A patient, public involvement (PPI) approach will be taken, with a PPI panel of experts overseeing and guiding the project for its duration. Results: The results of this research will output a primary version of the lifestyle weight management program for paediatric patients with demyelinating conditions, ready for a feasibility trial.
The Swiss-Ped-IBrainD is a national patient registry that collects information on diagnosis, symptoms, treatment, and follow-up of pediatric patients with an inflammatory brain disease in Switzerland. It was first implemented in 2020 in the pediatric clinic of the university hospital in Bern. Further centers all over Switzerland were opened for recruitment in 2021; Aarau, Basel, Bellinzona, Chur, Geneva, Lausanne, Lucerne, St. Gallen, and Zurich. The center in Winterthur is expected to be open for recruitment by autumn 2021. The registry provides data for national and international monitoring and research. It supports research on inflammatory brain diseases in Switzerland and the exchange of knowledge between clinicians, researchers, and therapists. The registry aims to improve the treatment of children with inflammatory brain diseases and optimizing their health care and quality of life.
Patients who have immune mediated diseases commonly undergo plasma exchange (PLEX) procedures to remove pathological substances, typically believed to be antibodies. At our facility about 400 of these procedures are performed annually on 40-60 different patients. These procedures are considered within the standard of care for these patients and are covered by insurance. This study will not influence the treatment plan for subjects who participate in this study. The goal of the study is to collect and cryopreserve blood biospecimens (plasma, serum, PBMCs) for current and future studies. Any patient undergoing plasma exchange procedures will be eligible for the study. Patients or the legally authorized representative (LAR) will be consented for the study as soon as feasible after the are referred to DeGowin for plasma exchange. The immediate objective of the study is to examine antibody levels (IgG/IgM) and BAFF levels in the blood of these patients over the course of the plasma exchange treatments. Specimens and clinical data will be collected such that other immune factors that may regulate B cell survival, proliferation and antibody secretion can be studied. Another goal of the study is to isolate and cryopreserve PBMCs at different points during the patient's treatment. This would allow the study of immune cells that may mediate these diseases. The study will also follow pathological antibodies over time in these patients so biospecimens can be obtained even after the completion of their course of plasma exchange treatments. The collection of biospecimens and clinical information from these subjects will help us understand the impact of plasma exchange on both normal and pathological immune factors in a variety of patients undergoing these procedures.