[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nmdar-autoimmune-encephalitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nmdar-autoimmune-encephalitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,70],{"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":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100477922","phase-3-a-study-to-evaluate-the-efficacy-safety-pharmacokinetics-pk-and-pharmacodynamics-pd-of-satralizumab-in-participants-with-anti-n-methyl-d-aspartic-acid-receptor-nmdar-or-anti-leucine-rich-glioma-inactivated-1-lgi1-encephalitis-100477922",false,"NCT05503264","A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis","A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Basket Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis","Cielo","Inclusion Criteria:\n\n* Reasonable exclusion of tumor or malignancy before baseline visit (randomization)\n* Onset of AIE symptoms ≤ 9 months before randomization\n* Meet the definition of \"New Onset\" or \"Incomplete Responder\" AIE\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab or placebo\n* For participants enrolled in the extended China enrollment phase at China's sites: participants who are current residents of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry\n\nNMDAR AIE Cohort:\n\n* Age ≥ 12 years\n* Diagnosis of probable or definite NMDAR encephalitis\n\nLGI1 AIE Cohort\n\n* Age ≥ 18 years\n* Diagnosis of LGI1 encephalitis\n\nExclusion Criteria:\n\n* Any untreated teratoma or thymoma at baseline visit (randomization)\n* History of carcinoma or malignancy, unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening\n* For participants with NMDAR AIE, history of negative anti-NMDAR antibody in cerebrospinal fluid (CSF) using a cell-based assay within 9 months of symptom onset\n* Historically known positivity to an intracellular antigen with high cancer association or glutamate decarboxylase 65 (GAD-65)\n* Historically known positivity to any cell surface neuronal antibodies other than NMDAR and LGI1, in the absence of NMDAR and LGI1 antibody positivity\n* Confirmed paraneoplastic encephalitis\n* Confirmed central nervous system (CNS) or peripheral nervous system (PNS) demyelinating disease\n* Alternative causes of associated symptoms\n* History of herpes simplex virus encephalitis in the previous 24 weeks\n* Any previous\u002Fconcurrent treatment with interleukin-6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation, or bone marrow transplantation\n* Any previous treatment with anti-cluster of differentiation 19 antibody (CD19 antibody), complement inhibitors, neonatal Fc receptor antagonists, anti-B-lymphocyte stimulator monoclonal antibody\n* Any previous treatment with T-cell depleting therapies, cladribine, or mitoxantrone\n* Treatment with oral cyclophosphamide within 1 year prior to baseline\n* Treatment with any investigational drug (including bortezomib) within 24 weeks prior to screening\n* Concurrent use of more than one immunosuppressive therapy (IST) as background therapy\n* Contraindication to all of the following rescue treatments: rituximab, intravenous immunoglobulin (IVIG), high-dose corticosteroids, or intravenous (IV) cyclophosphamide\n* Any surgical procedure, except laparoscopic surgery or minor surgeries within 4 weeks prior to baseline, excluding surgery for thymoma or teratoma removal\n* Planned surgical procedure during the study\n* Evidence of progressive multifocal leukoencephalopathy\n* Evidence of serious uncontrolled concomitant diseases\n* Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection\n* Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection\n* Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to baseline visit\n* Positive hepatitis B (HBV) and hepatitis C (HCV) test at screening\n* Evidence of latent or active tuberculosis (TB)\n* History of drug or alcohol abuse within 1 year prior to baseline\n* History of diverticulitis or concurrent severe gastrointestinal (GI) disorders that, in the investigator's opinion, may lead to increased risk of complications such as GI perforation\n* Receipt of live or live-attenuated vaccine within 6 weeks prior to baseline visit\n* History of blood donation (1 unit or more), plasma donation or platelet donation within 90 days prior to screening\n* History of severe allergic reaction to a biologic agent\n* History of suicide attempt within 3 years prior to screening except if this is clearly associated with and occurs during the acute phase of LGI-1 or NMDAR encephalitis\n* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes safe participation in and completion of the study\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug","ALL","12 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.",[27,28],"NMDAR Autoimmune Encephalitis","LGI1 Autoimmune Encephalitis","RECRUITING","2026-06-04",{"date":32,"type":33},"2026-06-08","ACTUAL",{"date":35,"type":33},"2022-09-27",{"date":37,"type":21},"2028-12-14",{"name":39,"class":40},"Hoffmann-La Roche","INDUSTRY",93,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100605108","long-term-impact-of-nmdar-encephalitis-level-3-100605108","NCT07158229","Long-term Impact of NMDAR Encephalitis, Level 3","Social and Psychological Long-term Impact of NMDA Receptor Encephalitis, Level 3","SAPIENCE 3","Inclusion Criteria:\n\n* Patients with NMDAR encephalitis\n* Age ≥ 18 years old\n* Patient affiliated to a social security system\n* No opposition from the patient\n* Access to an internet connection and a computer\n\nExclusion Criteria:\n\n* Patients whithout NMDAR encephalitis\n* Patient under guardianship or curatorship\n* Patient with neurological disorders pre-existing encephalitis","18 Years",{"count":52,"type":21},30,"OBSERVATIONAL","NMDA receptor antibody encephalitis is a rare autoimmune neurological disease of the central nervous system with an estimated incidence of 1.5 people per million per year. Patients with anti-NMDAR encephalitis experience an acute phase of the disease characterized by psychosis, memory loss, seizures, autonomic nervous system instability, or coma. Since the discovery of this disease 14 years ago by Prof. Dalmau, the clinical presentation of the acute phase has been well characterized, while the psychosocial impact of the disease remains largely unexplored.\n\nCurrently, there are few cohort studies of patients that have identified persistent cognitive impairment as a factor impacting remission after the acute phase. Given the scarcity of information concerning the post-acute phase, it is therefore essential to determine the long-term social and psychological outcomes and their daily effects on the social and functional life of this severe disease. This is especially important as the patients are young, with a median age of 21 years, and may face lasting limitations potentially detrimental to their success in professional, educational, or social environments.",[27],[57,58],"NMDAR encephalitis","psychosocial impact","2026-02-12",{"date":61,"type":33},"2026-02-17",{"date":63,"type":33},"2025-11-21",{"date":65,"type":21},"2026-11-21",{"name":67,"class":68},"Hospices Civils de Lyon","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":80,"conditions":81,"keywords":87,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":69},"100603176","medium-term-effects-of-treatments-in-autoimmune-encephalitis-100603176","NCT07133113","Medium-term Effects of Treatments in Autoimmune Encephalitis","Medium-term Effects of Treatments in Autoimmune Encephalitis (META): a Real-life, Observational Prospective Study","META","Inclusion Criteria:\n\n* Adult or child patient with encephalitis defined as anti-GAD, NMDAR, LGI1, CASPR2, IgLON5 or GFAP\n* Untreated or with a decision to treat within the previous 30 days.\n\nExclusion Criteria:\n\n\\- Refusal by the referring doctor to participate or refusal by the patient mentioned in the objection to the use of his\u002Fher clinical data.",{"count":79,"type":21},200,"Autoimmune encephalitides are severe neurological disorders requiring urgent treatment, even though there is no standard guideline by lack of empirical evidence. Commonly used treatments are divided into so-called first-line (steroids, intravenous immunoglobulins, plasma exchanges) and second-line (rituximab, cyclophosphamide, tocilizumab, others), and may be used in association or sequentially. There is no standard practice, and initial treatment protocol may consist in first-line alone, first-line with rituximab, or first-line with dual immunosuppression (rituximab and cyclophosphamide). Absence of clear response to initial treatment in the first 4 to 6 weeks may indicate undertreatment and is generally followed by treatment escalation, mostly to dual immunosuppression. However, as the frequency of non-responders to initial treatment is unknown, it is still unclear whether dual immunosuppression should be offered to all patients from inception.",[27,82,83,84,85,86],"LGI1 Antibody Associated Encephalitis","CASPR2-Antibody","IgLON5","GAD65","GFAP",[88,89],"Paraneoplastic neurological disorder","autoimmune encephalitis","2025-08-13",{"date":92,"type":33},"2025-08-20",{"date":94,"type":33},"2024-09-01",{"date":96,"type":21},"2027-03-01",{"name":67,"class":68}]