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Neuromyelitis Optica clinical trials

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NCT ID: NCT05314010 Recruiting - Clinical trials for Neuromyelitis Optica Spectrum Disorder

A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Start date: August 18, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder.

NCT ID: NCT05204459 Recruiting - Multiple Sclerosis Clinical Trials

MS-ResearchBiomarkerS

MS-ReBS
Start date: November 11, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT05199688 Recruiting - Clinical trials for Neuromyelitis Optica Spectrum Disorder

A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)

SAkuraSun
Start date: June 28, 2024
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT05154734 Recruiting - Clinical trials for NMO Spectrum Disorder

Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders

Start date: October 30, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT05154370 Recruiting - Multiple Sclerosis Clinical Trials

China National Registry of Neuro-Inflammatory Diseases

CNRID
Start date: December 15, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT05145361 Recruiting - Clinical trials for NMO Spectrum Disorder

Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)

Start date: April 7, 2022
Phase: Early Phase 1
Study type: Interventional

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.

NCT ID: NCT05070286 Recruiting - Multiple Sclerosis Clinical Trials

Lifestyle Weight Management Program: Interviews and Stakeholder Meetings.

Start date: January 1, 2022
Phase:
Study type: Observational

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.

NCT ID: NCT05017142 Recruiting - Multiple Sclerosis Clinical Trials

Swiss Pediatric Inflammatory Brain Disease Registry (Swiss-Ped-IBrainD)

Start date: April 14, 2020
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT05004493 Recruiting - Clinical trials for Antibody-mediated Rejection

Biorepository and Registry for Plasma Exchange Patients

Start date: July 28, 2021
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT04601142 Recruiting - Clinical trials for Neuromyelitis Optica

Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica (NMO) and Gene Polymorphism

Start date: October 31, 2020
Phase:
Study type: Observational

Aims of this study are to observe the correlation between ABCB1、VDR、TBX21、NR3C1 and other gene polymorphisms and the effect of glucocorticoid shock therapy on neuromyelitis optica. Investigators plan to include patients with neuromyelitis optica who will receive glucocorticoid shock therapy prospectively. The patients are divided into glucocorticoid sensitive (GS) group and glucocorticoid resistance (GR) group according to the change of central vision after treatment. Patients' clinical data will be collected and blood samples are needed for single nucleotide polymorphism (SNP) typing test. Through statistical analysis, the data differences between GS group and GR group were compared, and the effects of clinical indexes and gene polymorphisms on the efficacy of glucocorticoid shock therapy in the treatment of neuromyelitis optica should be analyzed.