[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuromyelitis-optica-spectrum-disorder-attack\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuromyelitis-optica-spectrum-disorder-attack":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100649808","phase-1-safety-and-efficacy-study-of-sivelestat-in-neuromyelitis-optica-spectrum-disorder-100649808",false,"NCT07738952","Safety and Efficacy Study of Sivelestat in Neuromyelitis Optica Spectrum Disorder","A Phase I\u002FIIa Investigator-Initiated Clinical Trial to Evaluate the Safety and Efficacy of Sivelestat in Patients With Acute Relapse of Neuromyelitis Optica Spectrum Disorder","SIVAR-NMOSD","Inclusion Criteria:\n\n1. Patients diagnosed with anti-AQP4 antibody-positive NMOSD according to the international diagnostic criteria for NMOSD (Wingerchuk, Neurology 2015).\n2. Patients experiencing a relapse including any of the following, with the relapse occurring within 14 days of obtaining consent:\n\n   i. Unilateral or bilateral optic neuritis ii. Myelitis\n3. Patients whose FS domain has worsened by at least 1 point due to relapse.\n4. Patients with one or more relapse lesions identified on MRI (however, if the relapse is considered to have occurred in the same location as an existing MRI lesion neurologically, identification of a new relapse lesion is not required).\n5. Patients aged 18 years or older at the time of obtaining consent.\n6. Female patients of childbearing potential who agree to use appropriate contraception from the time of obtaining consent until 180 days after the end of investigational product administration.\n7. Male patients who agree to use appropriate contraception until 90 days after the end of investigational product administration.\n8. Patients who can provide written informed consent.\n\nExclusion Criteria:\n\n1. Patients with multi-organ dysfunction involving 4 or more organs.\n2. Patients with severe chronic respiratory disease.\n3. Patients with autoimmune diseases other than NMOSD that are expected to require additional treatment during the study period.\n4. Patients with active systemic bacterial, viral, or fungal infections.\n5. Patients who have received either or both of the following prior treatments after an NMOSD relapse:\n\n   i. Two or more courses of steroid pulse therapy ii. Plasmapheresis iii. High-dose immunoglobulin therapy\n6. Patients with severe hepatic dysfunction.\n7. Patients with alcohol dependence, drug dependence, or psychiatric disorders that would interfere with study participation.\n8. Patients who have received other investigational drugs within 3 months prior to obtaining consent.\n9. Pregnant women, women suspected of being pregnant, or breastfeeding women.\n10. Patients with allergies to the investigational product or concomitant medications.\n11. Patients with severe allergies or a history of severe allergies.\n12. Patients with suicidal tendencies meeting any of the following criteria:\n\n    i. Within 1 month prior to the screening assessment, there was suicidal behavior or ideation corresponding to \"Yes\" for Item 4 (Active suicidal ideation -some intent to act, but no specific plan) or Item 5 (Active suicidal ideation -specific plan and intent) of the Columbia-Suicide Severity Rating Scale (C-SSRS). (For subjects who only met Items 1-3, inclusion may be permitted at the discretion of the principal investigator or sub-investigator.) ii. Any suicidal behavior based on Item 6 of the C-SSRS occurred within the past 3 months.\n13. Other patients judged inappropriate by the principal investigator or sub-investigator.","ALL","18 Years",{"count":20,"type":21},7,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The primary objective of this study is to evaluate the safety and tolerability of sivelestat sodium hydrate administered in combination with standard steroid pulse therapy in patients experiencing an acute NMOSD attack. Safety assessments will include adverse events, laboratory parameters, vital signs, and other clinically relevant findings. In addition, the study will explore whether the addition of sivelestat sodium hydrate to standard steroid pulse therapy improves neurological outcomes in patients with acute NMOSD.\n\nParticipants will receive intravenous sivelestat sodium hydrate at a dose of 4.8 mg\u002Fkg\u002Fday administered as a continuous infusion (0.2 mg\u002Fkg\u002Fhour) for 5 consecutive days, receive steroid pulse therapy according to the study protocol, and be followed for 28 days after treatment initiation for safety and efficacy evaluations.",[28],"Neuromyelitis Optica Spectrum Disorder Attack",[30,31],"NMOSD","Sivelestat","NOT_YET_RECRUITING","2026-07-27",{"date":35,"type":36},"2026-07-31","ACTUAL",{"date":38,"type":21},"2026-08-17",{"date":40,"type":21},"2028-05-31",{"name":42,"class":43},"Kyushu University","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100624469","phase-4-therapy-in-the-acute-phase-of-nmosd-a-multicenter-prospective-real-world-study-100624469","NCT07410039","Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study","Eculizumab Add-On Therapy in the Acute Phase of Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Real-World Study","ETA\u002FPETA-NMOSD","Inclusion Criteria:\n\n1. Age: 18 - 65 years old, gender not restricted.\n2. Patients who meet the diagnostic criteria for NMOSD as set by the International Panel for NMO Diagnosis (IPND) in 2015, and have positive serum AQP4-IgG (by CBA method or live cell method).\n3. Acute phase of NMOSD-ON, defined as new or worsening optic nerve dysfunction (visual acuity decline accompanied or not by eye pain and visual field defect), with an onset duration of ≤ 21 days, and clear evidence of new or recurrent optic nerve damage on imaging (new or expanded T2WI lesions, with enhancement); the best corrected visual acuity (BCVA) of the affected eye during the acute phase of NMOSD-ON (if both eyes are affected simultaneously, the worse eye is considered) drops from above 0.3 to ≤ 0.1.\n4. Acute phase of NMOSD-TM, defined as new or worsening spinal cord dysfunction (limb weakness or numbness, accompanied or not by urinary and defecation disorders), with an onset duration of ≤ 21 days, and clear evidence of new or recurrent spinal cord damage on imaging (new or expanded T2WI lesions, with enhancement); the EDSS score during the acute phase of NMOSD-TM increases from ≤ 4.0 to ≥ 6.0.\n5. Clinical onset and recurrence determination requires unanimous judgment by each center and the center committee (an independent group of 3 people).\n6. Agree to receive meningococcal vaccine or use eculizumab during and 2 weeks after the medication.\n7. Sign the informed consent.\n\nExclusion Criteria:\n\n1. Damage to the optic nerve or spinal cord caused by other non-NMOSD-related factors.\n2. Abnormal laboratory indicators that need to be excluded from the subjects include, but are not limited to the following indicators:\n\n   Neutrophils \\\u003C 1.5 × 109\u002FL, Hemoglobin \\\u003C 90g\u002FL, Platelet count \\\u003C 75 × 109\u002FL; Serum creatinine \\> 1.5 × ULN, Total bilirubin \\> 1.5 × ULN, Aspartate aminotransferase (AST) \\> 1.5 × ULN, Alanine aminotransferase (ALT) \\> 1.5 × ULN, Alkaline phosphatase \\> 2 × ULN ； HbA1c \\> 8% (for diabetic patients); GFR \\\u003C 60 mL\u002Fminute\u002F1.73m2.\n3. Pregnant or lactating women, as well as those planning to become pregnant during the study period.\n4. Those who have received PE\u002FIA\u002FIVIG\u002FFcRn\u002FB-cell deletion\u002FC5\u002FIL-6 treatment within 1 month before enrollment.\n5. Active infections: active hepatitis B, hepatitis C, syphilis or HIV infection; active systemic infections or immunodeficiency diseases; unrelieved meningococcal infection of the meninges, or patients with severe infections that cannot use immunosuppressive drugs.\n6. Patients with severe internal or external diseases (not limited to such as heart failure, unstable angina pectoris, respiratory failure, pulmonary insufficiency, cachexia, organ transplantation, etc.).\n7. Those who have had or currently have an untreated malignant tumor that is not well controlled.\n8. Patients with serious physical or mental diseases that may affect the smooth implementation of the study.\n9. Patients known to be allergic to monoclonal drugs, murine proteins or any excipients.\n10. Patients who are intolerant to methylprednisolone or gamma globulin.\n11. Patients who cannot complete the magnetic resonance enhanced scan screening.\n12. Patients who are participating in other interventional clinical trials.\n13. Patients who cannot understand the questionnaire questions or cooperate with the questionnaire survey.\n14. Situations that the research team collectively deems unsuitable for participation in this study.","65 Years",{"count":54,"type":21},200,[56],"PHASE4","This project is a multi-center, prospective, real-world cohort study that collects clinical data of Chinese patients with AQP4-positive NMOSD in the acute stage. It comprehensively assesses the clinical outcomes of the patients and aims to compare the clinical efficacy and safety of icoxib as a combined add-on treatment versus simple hormone shock therapy during the acute phase of NMOSD.Using simple hormone shock therapy (IVMP) as the control group, the efficacy and safety of etanercept treatment in the acute attack phase of Chinese patients with AQP4-positive neuromyelitis optica spectrum disorder (NMOSD) were evaluated.",[28],[60,61,62,63],"Neuromyelitis Optica Spectrum Disorder (NMOSD)","acute attack phase","eculizumab add-on therapy","AQP4-IgG positive","RECRUITING","2026-03-10",{"date":67,"type":36},"2026-03-12",{"date":69,"type":36},"2026-02-01",{"date":71,"type":21},"2029-06-30",{"name":73,"class":43},"Chinese PLA General Hospital",1]