[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuromyelitis-optica\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuromyelitis-optica":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,67,88,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100514778","longitudinal-cortical-demyelination-in-multiple-sclerosis-and-related-disorders-100514778",false,"NCT05982925","Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders","Longitudinal Investigation of Cortical Demyelination and Meningeal Inflammation in Multiple Sclerosis and Related Disorders","Inclusion Criteria:\n\n* 18 years old\n* able to provide consent in English\n* able to undergo MRI\n\nExclusion Criteria:\n\n* contraindication to MRI\n* pregnancy",true,"ALL","18 Years",{"count":20,"type":21},170,"ESTIMATED","OBSERVATIONAL","In this protocol, a combination of MRI, blood, and cerebrospinal fluid (CSF) analysis will be used to understand the natural history, underlying immunologic mechanisms, and clinical implications of central nervous system (CNS) lesions, in particular lesions in the cerebral cortex, in multiple sclerosis (MS) and other inflammatory and autoimmune disorders affecting the CNS. Patients with these disorders, as well as healthy controls, will undergo baseline clinical evaluation and testing, bloodwork, and MRI, with follow up clinical evaluation, bloodwork, and MRI at years 1, 3, and 6. Additional MRIs may be performed in patients with possible new lesion formation or to compare MRI techniques. Lumbar puncture will be performed on participants who are not currently being treated with disease modifying therapies and who are willing to undergo the procedure.",[25,26,27],"Multiple Sclerosis","Neuromyelitis Optica","Demyelinating Autoimmune Diseases, CNS","RECRUITING","2026-06-12",{"date":31,"type":32},"2026-06-15","ACTUAL",{"date":34,"type":32},"2022-05-06",{"date":36,"type":21},"2034-07-31",{"name":38,"class":39},"Icahn School of Medicine at Mount Sinai","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100605236","inectolizumab-with-steroid-optimization-in-newly-treated-nmosd-100605236","NCT07159893","Inectolizumab With Steroid Optimization in Newly Treated NMOSD","Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease","Inclusion Criteria:\n\n* Patients who meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and are AQP4-IgG positive, with a first-attack episode;\n* Male or female,age \\>=18 and \\\u003C=65 years old;\n* EDSS score ≤ 7.5;\n* Female subjects of childbearing potential must have a negative pregnancy test result during the screening period and must use effective contraception throughout the study period;\n* Voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Laboratory abnormalities include: (white blood cell count \\\u003C 3×10⁹\u002FL), (neutrophils \\\u003C 1.5×10⁹\u002FL), (hemoglobin \\\u003C 85 g\u002FL), (platelet count \\\u003C 80×10⁹\u002FL), (serum creatinine \\> 1.5×ULN), (total bilirubin \\> 1.5×ULN), (AST (GOT) \\> 3×ULN), (ALT (GPT) \\> 3×ULN), (alkaline phosphatase \\> 2×ULN).\n* Patients currently suffering from active hepatitis or with a history of severe liver disease are ineligible. Based on the following serological test results for HBsAg, anti-HBc antibodies, and anti-HBs antibodies, there is evidence of hepatitis B virus (HBV) infection: Patients with positive HBsAg should be excluded. For patients with negative HBsAg but positive anti-HBc antibodies, regardless of whether anti-HBs antibodies are positive or negative, HBV-DNA testing is required to determine their status: If HBV-DNA is positive, the patient should be excluded; if HBV-DNA is negative, the patient may be eligible for the trial.\n* Patients with other chronic active immune system diseases, or those with stable conditions but requiring glucocorticoid therapy, are excluded, except for neuromyelitis optica spectrum disorder (NMOSD). Examples include rheumatoid arthritis, scleroderma, Sjögren's syndrome, ulcerative colitis, AIDS, genetic immunodeficiency, or drug-induced immunodeficiency. Patients with only positive autoantibodies but without clinical manifestations may be eligible for the trial.\n* Pregnant women, breastfeeding women, and patients who plan to conceive during the trial period.\n* Allergic reactions: Patients with a history of allergies to contrast agents administered via the parenteral route or to human-derived biological products.\n* Patients who received a live vaccine, except for the herpes zoster vaccine, within 28 days prior to randomization.\n* Patients who have used rituximab or other monoclonal antibodies within 6 months prior to randomization\n* Patients who have received intravenous immunoglobulin (IVIG) within 28 days prior to randomization.\n* Patients who have undergone hematopoietic stem cell transplantation or lymphocyte irradiation before randomization.\n* Patients who have used immunosuppressive agents such as azathioprine (Azathioprine, AZA, half-life t1\u002F2 = 6 hrs), mycophenolate mofetil (Mycophenolate Mofetil, t1\u002F2 = 16 hrs), leflunomide (Leflunomide, LEF, t1\u002F2 = 14.7 hrs), tacrolimus (Tacrolimus, t1\u002F2 = 43 hrs), teriflunomide (Teriflunomide, t1\u002F2 = 18 days), cyclosporine (Cyclosporin, CsA, t1\u002F2 = 27 hrs), methotrexate (Methotrexate, MTX, t1\u002F2 = 14 hrs), mitoxantrone (Mitoxantrone, NVT, t1\u002F2 = 37 hrs), and cyclophosphamide (Cyclophosphamide, CTX, t1\u002F2 = 6 hrs) before randomization are excluded. Except for leflunomide and teriflunomide, patients can be enrolled if the washout period exceeds five half-lives. For leflunomide and teriflunomide, patients need to undergo cholestyramine washout as follows: take 8 grams of cholestyramine orally three times daily for 11 days. If the 8-gram dose is not tolerated, it can be changed to 4 grams per dose, with the same frequency and duration.\n* Patients who have received any investigational drug within 28 days or five half-lives of the trial drug (whichever is shorter) before randomization.\n* Patients with symptoms of severe mental illness who are clinically unable to co-operate;\n* Patients with malignant tumours.\n* Patients who have experienced any of the following events within 12 weeks prior to randomization: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association (NYHA) Class IV heart failure.\n* Patients with herpes zoster infection, positive for HCV antibodies, or positive for HIV antibodies during the screening period.\n* Patients who are unable to undergo magnetic resonance imaging (MRI) during the trial period.\n* Patients whom the investigator deems unsuitable for participation in the trial.","65 Years",{"count":50,"type":21},25,"INTERVENTIONAL",[53],"NA","Title: Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease Objective:This study aims to evaluate the steroid-sparing effect and safety of inebilizumab in treatment-naïve AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) patients, while assessing its impact on EDSS score improvement during acute-phase treatment. The study will further explore treatment-related biomarkers, including dynamic changes in: immunoglobulin levels, lymphocyte subset profiles, serum AQP4-IgG titers, glial fibrillary acidic protein (GFAP), and neurofilament light chain (NFL) levels.\n\nStudy Design:This is a single-center, randomized, open-label, prospective clinical study planning to enroll 25 treatment-naïve, anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD) patients.",[26,56,27],"Autoimmune Diseases","NOT_YET_RECRUITING","2025-09-04",{"date":60,"type":32},"2025-09-08",{"date":62,"type":21},"2025-09",{"date":64,"type":21},"2026-09",{"name":66,"class":39},"First Affiliated Hospital of Wenzhou Medical University",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":40},"100546685","study-of-the-clinical-and-radiological-impact-of-ravulizumab-in-people-with-neuromyelitis-optica-spectrum-disorder-100546685","NCT06398158","Study of the Clinical and Radiological Impact of Ravulizumab in People With Neuromyelitis Optica Spectrum Disorder","Clinical and Radiological Outcomes in People With Aquaporin-4 IgG Positive Neuromyelitis Optica Spectrum Disorder Treated With Ravulizumab","AMAZE","Inclusion Criteria:\n\n1. Signed informed consent available prior to conduct of any study associated activities\n2. Men and women \\> 18 years of age\n3. Aquaporin-4 IgG positive people with neuromyelitis optica spectrum disorder treated with commercially available ravulizumab in a manner consistent with the approved indication\n4. Expanded Disability Status Scale score of \\\u003C7.0\n\nExclusion Criteria:\n\n1. Individuals who are intolerant to MRI\n2. Individuals previously exposed to eculizumab with treatment discontinuation due to lack of effective disease control (i.e., clinical relapse or demonstration of MRI advancement after 12 weeks of sustained treatment exposure)\n3. Unresolved meningococcal disease\n4. History of an active infection\n5. Existing participation in neuromyelitis optical spectrum disorder interventional clinical studies\n6. Pregnant or lactating women",{"count":76,"type":21},35,"This is an observational study to:\n\n* evaluate the on-treatment clinical performance of ravulizumab in relation to the pre-treatment time period (time period prior to exposure),\n* enhance knowledge regarding conventional MRI outcomes in people with NMOSD treated with ravulizumab,\n* identify factors suggestive of subclinical disease progression through conventional MRI sequences,\n* determine if treatment with ravulizumab, impacts longitudinal 3D conformational MRI measures at the dorsal medulla and other regions of the CNS, and\n* identify biomarkers (e.g., serum neurofilament light chain (sNfL), conventional and novel MRI markers, etc.) related to disease activity.",[26],"2025-07-31",{"date":81,"type":32},"2025-08-05",{"date":83,"type":32},"2024-07-10",{"date":85,"type":21},"2027-06-30",{"name":87,"class":39},"University of Texas Southwestern Medical Center",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":51,"phases":98,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":112,"locationsCount":114},"100482802","performance-and-safety-of-a-digital-tool-for-unsupervised-self-assessment-of-nmosd-100482802","NCT05566769","Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD","Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder","OPTIS","Inclusion Criteria:\n\n* Aged over 18 years old\n* NMOSD as defined by the 2015 international consensus diagnostic criteria (AQP4+ only)\n* With NMOSD treatment (treatment must be unchanged since 6 months before enrollment, and 1 month for analgesics, antidepressants, neuroleptics)\n* EDSS =\\\u003C 7\n* With no evidence of relapse in the past 3 months before enrollment\n* Who have read the information sheet and signed the informed consent form\n* Able to use a smartphone\n* Owns a personal smartphone which version is above 13 for IOS and 8 for Android included\n* Able to read language in which the mobile application is available and able to understand pictograms\n\nExclusion Criteria:\n\n* Evidence of neurologic, rheumatologic or psychiatric disorder other than NMOSD, including but not limited to major head trauma, seizures or systemic medical diseases that are likely to affect cognitive, upper limb or lower limb functioning\n* Pregnant and nursing women\n* Person under guardianship or curatorship\n* Bedridden patients or patients with a daily activity of less than 2 hours per day\n* Current drugs or\u002Fand alcohol abuse that could influence performance on the tests (clinician's judgment)\n* Subject has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the participant's full participation in the study or confound the assessment of the participant or outcome of the study.",{"count":97,"type":21},103,[53],"NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and quality of life. It has been co-designed with the help of patient advocacy groups, NMOSD patients and medical experts. It includes a smartphone-based application for patients, connected to a web portal developed for healthcare professionals (HCSPs). The patient application is composed of vision, walking, cognition, and dexterity e-active tests inspired by clinical standards, as well as e-questionnaires. The HCP web portal is a desktop-based software that allows HCPs to access the results generated via the patient application and facilitates remote monitoring of patients' symptoms.\n\nThe objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone versus the standard in-clinic testing, as well as to evaluate the safety of use of the tool, its usability, and satisfaction towards the patient application among NMOSD patients, and the HCP web dashboard among HCPs.",[26],[102,103,104,105],"NMO","NMOSD","Neuromyelitis optica","Neuromyelitis optica spectrum disorder","2025-04-08",{"date":108,"type":32},"2025-04-10",{"date":110,"type":32},"2023-11-03",{"date":64,"type":21},{"name":113,"class":39},"Ad scientiam",22,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":51,"phases":126,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":4},"100554306","phase-2-fcrn-antagonists-efgartigimod-for-acute-nmosd-attack-100554306","NCT06497374","FcRn Antagonists (Efgartigimod) for Acute NMOSD Attack","FcRn Antagonists (Efgartigimod) for Acute Neuromyelitis Optica Spectrum Disorders (NMOSD) Attack: a Phase 2, Randomized Controlled Trial.","FACT","Inclusion Criteria:\n\n1. Male or female, ages 18 to 75.\n2. Meet the 2015 International Panel of Experts (IPND) diagnostic criteria for neuromyelitis optica spectrum disorders.\n3. Acute EDSS nadir of 2.5-7.5, and a change of at least 0.5 points from baseline due to an acute relapse event.\n4. Confirmation of serum AQP4-IgG antibody positivity using the CBA assay.\n5. Confirmation of an acute attack of neuromyelitis optica spectrum disorders either with an acute optic neuritis and\u002For acute myelitis, defined as a worsening in the patient's signs and symptoms of neurological\u002Fvisual impairment, an increase in the EDSS score, and symptoms lasting more than 24 hours and occurring more than 1 month since the last attack. Combination of imaging and clinical evaluation will be used to assess relapse and rule out a pseudorelapse.\n6. New lesions or enhanced lesions need to be found in MRI.\n7. Subjects who were receiving immunosuppressive therapy prior to the screening period will be required to agree to discontinue immunosuppression.\n8. Treatment is stable at least 3 months.\n\nExclusion Criteria:\n\n1. Other core clinical symptoms besides optic neuritis and myelitis.\n2. Severe neuromyelitis optica spectrum disorder attack, which in the judgment of the investigator is not appropriate for this study. Severe is defined as requiring assisted ventilation or likely to require assisted ventilation during the study based on the judgment of the investigator.\n3. Subjects with total IgG levels ≤ 6 g\u002FL at screening.\n4. Subjects with a B-cell count ≤ 5% of the lower limit of normal at screening.\n5. Received high-dose intravenous methylprednisolone within 4 weeks prior to the screening period.\n6. Received intravenous immunoglobulin, plasma exchange, or immunoadsorption treatment within 4 weeks prior to the screening period.\n7. Received a vaccination within the first 4 weeks of the screening period or planned during the study.\n8. Using of a monoclonal antibody or investigational drug not mentioned above that has immunomodulatory effects within 3 months or 5 half-lives (whichever is longer) prior to the screening period.\n9. Subject is known to be allergic to any component of the study drug or any other FcRn drug or contrast medium for enhanced MRI.\n10. Subject is known to have contraindications to taking methylprednisolone (for subjects in A and B group).\n11. Subjects with clinically significant active infections (including unresolved or inadequately treated infections, including active tuberculosis) as assessed by the investigator.\n12. Subjects with positive screening tests for hepatitis B and C who have received live or live attenuated vaccine within 6 weeks prior to baseline.\n13. Subjects is known unable to taken MRI.\n14. Subjects is known to have other ophthalmic disease that affect vision as assessed by the investigator.","75 Years",{"count":125,"type":21},63,[127],"PHASE2","NMOSD is an autoimmune disease of the central nervous system that predominantly affects the spinal cord and optic nerves. The objectives of this study are to assess the efficacy and safety of FcRn antagonists (efgartigmod) for treatment of patients with neuromyelitis optica spectrum disorders during acute phase who are anti-aquaporin-4 (AQP4) antibody-positive. The potential of efgartigimod, an IgG1 Fc fragment that competes with IgG for FcRn binding, thereby lowering IgG levels, warrants further investigation as a treatment for acute neuromyelitis optica spectrum disorders attacks. This study aims to evaluate the therapeutic potential of efgartigmod in acute NMOSD attack.",[26,130,131],"Neuromyelitis Optica Spectrum Disorder","NMO Spectrum Disorder","2024-07-04",{"date":134,"type":32},"2024-07-11",{"date":136,"type":21},"2024-07-05",{"date":138,"type":21},"2026-06-30",{"name":140,"class":39},"Tianjin Medical University General Hospital"]