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NMO Spectrum Disorder clinical trials

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NCT ID: NCT06443333 Recruiting - Multiple Sclerosis Clinical Trials

National, Multicentric Registry Study on Neuroimmunological Diseases in China

NIDBase
Start date: December 1, 2020
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to establish a real-world clinical neuroimmune disease research cohort, to follow up and observe the prognosis of patients with different subtypes and subgroups, and to provide support for the treatment, early warning, and outcome prediction research of neuroimmune diseases.

NCT ID: NCT05840055 Recruiting - Clinical trials for NMO Spectrum Disorder

ACT With NMOSD Patients and Caregivers Pilot Study

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

This study will examine the effectiveness of a neuromyelitis optics spectrum disorder (NMOSD) specific Acceptance and Commitment Therapy (ACT) intervention at reducing anxiety and depression in individuals with NMOSD and their caregivers/loved ones and improving overall health outcomes in individuals with NMOSD.

NCT ID: NCT05792462 Recruiting - Clinical trials for NMO Spectrum Disorder

Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders

Start date: April 15, 2023
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. Baricitinib is an oral Janus kinase (JAK)1/JAK2 inhibitor that blocks the upregulated JAK-STAT pathway in patients with neuroimmune disorders, which is important in bone marrow regulation of B cell proliferation and differentiation. Baricitinib 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: NCT05414890 Recruiting - Autoimmune Diseases Clinical Trials

Sensitivity and Specificity of TSA-CBA for Autoantibodies Against Neural Antigen Determination

STAND
Start date: June 30, 2022
Phase:
Study type: Observational

Determination of autoantibodies against fragments derived from neurons, glia, and myelin sheath is instrumental in aiding diagnosis, differential diagnosis, as well as determining disease status of neuromyelitis optica spectrum disorders (NMOSD), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), autoimmune encephalitis (AE). Cell based assay (CBA) has been frequently recommended to detect autoantibodies of neuroantigens in the aforementioned neurological disorders. However, antibodies with low abundance or low affinity often fall beyond the threshold of CBA and pose significant challenges in practice. To this end, the investigators adopted a tyramide signal amplification (TSA) technology with the basis of CBA to improve sensitivity. The preliminary results suggest that this TSA-CBA platform is superior to conventional CBA in registered signals of the titer autoantibodies. In elevating the sensitivity, TSA-CBA also preserves antigen confirmation. This prospective study is launched to compare the sensitivity, specificity, clinical correlation between CBA and CBA-TSA, in determining autoantibodies against aquaporin 4 (AQP4-IgG), myelin oligodendrocyte glycoprotein (MOG-IgG), N-methyl-D-aspartate receptor (NMDAR-IgG) in a multicenter, double-blind setting.

NCT ID: NCT05403138 Recruiting - Clinical trials for Neuromyelitis Optica

Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders

DAWN
Start date: November 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The objectives of this time-to-event study were to assess the efficacy and safety of Daratumumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4) antibody-positive. NMOSD is an autoimmune disease of the central nervous system that predominantly affects the spinal cord, optic nerves, and area postrema. It is usually mediated by the pathogenic AQP4-IgG. Antibody-secreting cells (ASCs) have been recognized as essential sources of AQP4-IgG. CD38 is a glycoprotein that is highly expressed on ASCs. Daratumumab, a CD38-directed monoclonal antibody, has been shown to decrease the levels of autoantibodies in lupus, myasthenia gravis, or autoimmune encephalitis. This randomized controlled study aims to evaluate the therapeutic potential of daratumumab in NMOSD.

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: 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: NCT04106830 Recruiting - Multiple Sclerosis Clinical Trials

Clinical and Imaging Patterns of Neuroinflammation Diseases in China (CLUE)

Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

CLUE is a prospective study to determine structural and functional changes of brain and spinal cord, as well as the inflammatory environment in patients with neuroinflammatory and demyelination disease. Subjects will receive new magnetic resonance (MR) technics including double inversion recovery (DIR) imaging diffusion kurtosis imaging (DKI), quantitative susceptibility mapping (QSM) and resting-state functional imaging and follow up for one year.