[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stiff-person-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stiff-person-syndrome":145},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,74,102,131,157],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100635461","phase-3-a-study-investigating-intravenous-human-normal-immune-globulin-10-in-adults-with-stiff-person-syndrome-100635461",false,"NCT07552987","A Study Investigating Intravenous Human Normal Immune Globulin 10% in Adults With Stiff Person Syndrome","A Phase III, Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of Intravenous Human Normal Immune Globulin (IGIV) 10% in Adult Patients With Stiff Person Syndrome","Inclusion Criteria:\n\n1. Male or female, 18-70 years of age.\n2. Patient has signed the Informed Consent Form (ICF).\n3. Diagnosed with SPS per the following criteria:\n\n   a. Clinical symptoms (must have 1 of 2) i. Stiffness (axial regions, limbs, or both) ii. Episodic spasms (axial regions, limbs, or both) triggered by noises, tactile stimuli, emotional stress.\n\n   b. Clinical signs during symptomatic phase of illness (must have 1 of 3) i. Increased muscle tone (axial or limbs) ii. Exaggerated lumbar lordosis iii. Concurrent stiffness of lumbar paraspinal and abdominal muscles. c. Serological findings (must have 1 of 2), based on participant medical history: i. High-titer GAD65-IgG in the serum (e.g. ≥ 20 nmol\u002FL by radio-immunoprecipitation assay or 10,000 IU\u002FmL by enzyme-linked immunoassay \\[ELISA\\]) or any positive titer in cerebrospinal fluid \\[CSF\\] ii. Glycine-R-IgG in serum and\u002For CSF by live cell binding assay.\n4. Patients must have paravertebral stiffness and torso\u002Flower extremity predominance.\n5. Distribution of stiffness index score of ≥ 2, including stiffness in the legs or trunk.\n6. Patient may be Ig-naïve or Ig-pre-treated, however they should not have received Ig within 3 months prior to the time of study entry (Day 0).\n\n   1. Includes newly diagnosed patients\n   2. Includes patients who have received symptomatic treatments only\n   3. Includes patients who have failed to respond to rituximab.\n7. Patients who have received rituximab in the past 18 months must have B-cell reconstitution test results available from within 3 months prior to enrolment that confirms restoration of humoral immunity.\n8. Daily symptomatic therapy has been stable for a minimum of two weeks prior to screening and is expected to remain stable throughout the duration of the study.\n9. Willing to comply with all requirements of the protocol, including travel to site for scheduled protocol assessments and treatment, and completion of a diary for the study duration.\n10. For women of childbearing potential (WOCBP), a negative urine pregnancy test at screening, on enrollment (Day 0), and agreement to employ effective birth control measures during the study until the end of study (EOS) visit.\n11. Authorization to access personal health information.\n\nExclusion Criteria:\n\n1. Patients incapable of giving informed consent.\n2. Patients with SPS-plus or variants of SPS such as paraneoplastic or progressive encephalomyelitis with rigidity and myoclonus (PERM). Patients with pure cerebellar ataxia, ocular motor apraxia.\n3. Patients who are bed-bound or wheelchair-dependent.\n4. Ongoing\u002Factive infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV Type 1\u002F2 infection. Subjects with chronic hepatitis B or hepatitis C infection currently on treatment may participate if they have undetectable viral load within 12 months of screening date.\n5. Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to glycine (used as an excipient).\n6. Patient with known Immunoglobulin A (IgA) deficiency and antibodies against IgA.\n7. Patients who are planning to receive the following treatments within the coming 12 months, or who have received in the stated timeframe before enrollment (Day 0)\n\n   1. Botulinum toxin within 6 months\n   2. Rituximab within 6 months\n   3. Steroid-sparing immunosuppressants (azathioprine, methotrexate, cyclophosphamide, or mycophenolate mofetil) within 1 month\n   4. Plasmapheresis within 3 months.\n8. Prior chimeric antigen receptor (CAR)-T cell therapy or autologous hematopoietic stem-cell transplantation.\n9. Received any blood, blood product, or blood derivative within 1 month of the baseline visit.\n10. Had therapy with live attenuated virus vaccines within 3 months of the baseline visit.\n11. Use of loop diuretics within 1 week of the baseline visit.\n12. Patients at high-risk of thrombotic events such as deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction.\n13. Uncontrolled hypertension (i.e., diastolic blood pressure \\[BP\\] \\> 100 mmHg and\u002For systolic BP \\> 160 mmHg). If a single measure exceeds this limit, a triple repeat measurement may be performed and the average of the three measurements used.\n14. Congestive heart failure as per New York Heart Association III\u002FIV, cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g., atrial fibrillation), unstable or advanced ischemic heart disease, hyperviscosity.\n15. Patients with significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia.\n16. Patients with hyperproteinemia, increased serum viscosity, and\u002For hyponatremia.\n17. Severe liver or kidney disease (normal reference ranges of laboratory doing the analysis):\n\n    1. Alanine aminotransferase (ALT) or aspartate amino transferase (AST) \\>2.5x upper limit of normal (ULN)\n    2. Creatinine \\> 120 µmol\u002FL\n    3. Blood urea nitrogen (BUN) \\> 2.5x ULN.\n18. Signs of severe anemia: Hemoglobin of less than 7 g\u002FdL, hemodynamically unstable due to active bleeding, and\u002For when evidence of end-organ ischemia secondary to severe anemia is present.\n19. Body mass index \\> 35 kg\u002Fm2 or an IVIg dose that puts the patient at risk of fluid overload.\n20. History of a malignant disease within 3 years of the baseline visit other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin.\n21. Patients having participated in an interventional, investigational clinical study within 30 days of the baseline visit, or within 5 half-lives of the investigational medicinal product (IMP) under investigation.\n22. Any condition that the Investigator believes is likely to interfere with evaluation of the IMP or with satisfactory conduct of the trial.","ALL","18 Years","70 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of QIVIGY (Intravenous Human Normal Immune Globulin 10%) compared with placebo in adult participants with stiff person syndrome (SPS).",[27],"Stiff Person Syndrome",[27,29,30,31,32],"SPS","Neurological Disorders","Autoimmune Disease","Human Immunoglobulin","NOT_YET_RECRUITING","2026-06-08",{"date":36,"type":37},"2026-06-10","ACTUAL",{"date":39,"type":21},"2026-09",{"date":41,"type":21},"2028-07",{"name":43,"class":44},"Kedrion S.p.A.","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100623942","a-long-term-follow-up-study-for-participants-previously-treated-with-kyv-101-100623942","NCT07403188","A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101","KYSA-4","Inclusion Criteria:\n\n* Provided informed consent for the LTFU study\n* Received at least 1 infusion of KYV-101 as part of a previous KYV-101 parent treatment protocol\n\nExclusion Criteria:\n\n* Not applicable",{"count":53,"type":21},70,"OBSERVATIONAL","The purpose of this long-term follow-up (LTFU) study is to collect delayed adverse events (AEs) and understand the persistence of KYV-101 (autologous CAR T cell product; gene-modified product), in participants who have been administered KYV-101 (gene-modified product; autologous CAR T cell product).\n\nThis LTFU protocol will be open to any participant who received at least one infusion of KYV-101 in a previous Kyverna sponsored clinical trial or Investigator Initiated Trial (IIT).",[57,58,27,59,60,61,62],"Refractory Lupus Nephritis","Myasthaenia Gravis","Rheumatoid Arthritis (RA)","Multiple Sclerosis","Dermatomyositis","Systemic Sclerosis (SSc)","RECRUITING","2026-02-03",{"date":66,"type":37},"2026-02-11",{"date":68,"type":37},"2025-11-24",{"date":70,"type":21},"2041-01",{"name":72,"class":44},"Kyverna Therapeutics",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100619223","phase-1-a-study-of-c-car168-in-the-treatment-of-central-nervous-system-autoimmune-diseases-refractory-to-standard-therapy-100619223","NCT07341828","A Study of C-CAR168 in the Treatment of Central Nervous System Autoimmune Diseases Refractory to Standard Therapy","An Exploratory Clinical Study of Anti-CD20\u002FB-cell Maturation Antigen(BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Central Nervous System Autoimmune Diseases Refractory to Standard Therapy","Inclusion Criteria:\n\n* 18 to 70 years old at the time of signing the Informed Consent Form (ICF).\n* Diagnosed as Multiple Sclerosis (MS)\u002FNeuromyelitis Optica Spectrum Disorders (NMOSD)\u002FAutoimmune Encephalitis(AiE)\u002FStiff Person Spectrum Disorder(SPSD) according to recognized diagnostic criteria for at least 6 months.\n* Prior treatment failure with standard therapy.\n* Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.\n\nExclusion Criteria:\n\n* Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive, Epstein-Barr Virus (EBV) DNA positive.\n* Uncontrolled active infection.\n* Live vaccine injection within 4 weeks prior to signing the ICF.\n* Major organ transplantation history or bone marrow\u002Fhematopoietic stem cell transplantation history.\n* Severe cardiovascular diseases within the past 6 months prior to screening.\n* A history of ≥ Grade 2 bleeding within 4 weeks prior to screening, or requiring long-term anticoagulants treatment.\n* Inadequate washing time for previous treatment.\n* Previously treated with CAR-T cell products or genetically modified T cell therapies.\n* Pregnant or lactating women.\n* Severe central nervous system diseases or pathological changes.\n* Malignancy history within 5 years prior to signing the ICF.\n* Any contraindication to lumbar puncture.",{"count":82,"type":21},15,[84],"PHASE1","This is an investigator-initiated, single-center, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with central nervous system autoimmune diseases refractory to standard therapy",[87,88,89,27],"Multiple Sclerosis (MS)","Neuromyelitis Optica Spectrum Disorders (NMOSD)","Autoimmune Encephalitis",[91],"CD20\u002FBCMA-directed CAR-T cells","2026-01-13",{"date":94,"type":37},"2026-01-15",{"date":96,"type":21},"2026-02",{"date":98,"type":21},"2029-02",{"name":100,"class":101},"Huashan Hospital","OTHER",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":73},"100570137","early-phase-1-extracorporeal-photopheresis-ecp-in-the-treatment-of-stiff-person-syndrome-option-study-100570137","NCT06703333","Extracorporeal Photopheresis (ECP) in the Treatment of Stiff Person Syndrome (OPTION Study)","A Pilot Study Evaluating the Safety of Extracorporeal Photopheresis (ECP) in the Treatment of Stiff Person Syndrome (OPTION Study)","OPTION","Inclusion Criteria:\n\n* Documented history of classical SPS with serum and CSF anti-GAD antibodies.\n* Age ≥ 18 ≤ 75 years.\n* Weight ≥ 50 kg.\n* Hematocrit ≥ 30 % (with or without transfusion support).\n* Platelet count ≥ 100 x 10\\^3\u002FuL (with or without transfusion support).\n* Willingness to use at least one reliable method of birth control (e.g., abstinence, oral contraceptives, intrauterine devices, barrier method with spermicide, or surgical sterilization) throughout the study for all men and women of childbearing potential.\n* Willingness to participate in all study tests, visits, and procedures (including ECP), as outlined in the informed consent.\n* Adequate peripheral venous access to initiate ECP therapy.\n* The patient agrees to participate in the trial and signs the informed consent form.\n\nExclusion Criteria:\n\n* Progressive encephalomyelitis with rigidity and myoclonus (PERM).\n* Paraneoplastic variants of SPS.\n* Concurrent diagnosis of a neurological condition that would interfere with the assessment of SPS.\n* Women who are pregnant and\u002For lactating.\n* Absolute medical contraindication to receive ECP.\n\n  * Hypersensitivity or allergy to psoralen (methoxalen).\n  * Hypersensitivity or allergy to heparin.\n  * Previous history of heparin-induced thrombocytopenia.\n  * Aphakia or photosensitive disease (systemic lupus erythematosus, porphyrias, etc.).\n* Laboratory evidence of any of the following:\n\n  * Mononuclear cell (MNC) count \\\u003C2.0 x 10\\^3 cells\u002FuL.\n  * Serum transaminase levels \\> x 2 UNL.\n  * Estimated Glomerular Filtration Rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m2.\n* Evidence of known infection with human immunodeficiency virus (HIV) or hepatitis B.\n* Uncontrolled infection requiring treatment at study entry.\n* Use of any investigational drug\u002Ftreatment at the time of enrollment or within the previous 60 days, or five elimination half-lives, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.\n* Previous history of skin cancer, leukemia \u002F lymphoma \u002F myeloma, or bone marrow transplant.\n* Any other disease or condition which, in the opinion of the investigator, could interfere with participation according to the study Protocol, or with the ability of the patients to cooperate and comply with study procedures.\n* Inability to provide informed consent.","75 Years",{"count":112,"type":21},3,[114],"EARLY_PHASE1","OPTION study is a pilot, open-label, prospective, and multicentric clinical trial involving outpatients with a diagnosis of classical stiff person syndrome (SPS), whereas extracorporeal photopheresis (ECP) is the investigational treatment. The study will be conducted at the Specialized Rehabilitation Hospital\u002FCapital Health and Yas Clinic Khalifa City (YCKC) Hospital (managed by Abu Dhabi Stem Cells Center -ADSCC), clinical sites responsible for patient assessment and inclusion, and follow-up consultations, according to the approved Protocol, while YCKC will be the site in which patients will undergo the investigational intervention (ECP).",[27],[27,118,119,120],"Extracorporeal Photopheresis","ECP","Immunoregulation","2025-10-01",{"date":123,"type":37},"2025-10-06",{"date":125,"type":21},"2026-01",{"date":127,"type":21},"2027-07",{"name":129,"class":130},"Yandy Marx Castillo Aleman","OTHER_GOV",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":73},"100556691","phase-2-efgartigimod-for-stiff-person-syndrome-esps-100556691","NCT06528392","Efgartigimod for Stiff Person Syndrome (ESPS)","ESPS","Inclusion Criteria:\n\n1. Age 18-80, men and women, capable of giving informed consent.\n2. Must have unexplained stiffness of limb and axial (trunk) muscles and involuntary striated muscle spasms.\n3. DSI and HHS must be \\>=2 (to allow for detection of improvement).\n4. Presence of serum (or CSF) anti-GAD antibodies regardless of titers.\n5. Stable dosage for at least two months before screening visit with antispasmodics (muscle relaxants, benzodiazepines, baclofen).\n6. Women with children bearing potential must be willing to use highly effective contraception method during and for a minimum of 90 days after the last dose of IP.\n\nExclusion Criteria:\n\n1\\. Exclusionary conditions:\n\n1a. type 1 DM\n\n1b. Cancer, except basal cell skin cancer\n\n1c. Infections: HIV, Hepatitis B or C, clinically significant active infection not sufficiently resolved in the investigator's opinion\n\n1d. Serum IgG (\\\u003C6 g\u002FL) at screening\n\n1e. pregnancy\u002Fbreast feeding. 2. Exclusionary medications: rituximab within 6 months of screening. 3. IVIG or PLEX treatment 4 weeks prior to screening. 4. History of any type of solid organ or bone marrow transplant.","80 Years",{"count":140,"type":21},10,[142],"PHASE2","The goal of this clinical trial is to examine the proportion of patients with stiff person syndrome with no worsening in stiffness and\u002For spasms while on efgartigimod-hyaluronidase (EFD) when compared to their current treatment. The main questions it aims to answer are:\n\n* proportion of patients with stiff person syndrome with no worsening in DSI and HSS scores\n* whether there are changes in laboratory values, vital signs, electrocardiogram, or depression, and suicide risk during the trial, as well as the incidence of any adverse events.\n\nParticipants will come to the clinic up to 18 times and have up to 5 phone call visits during the course of the trial. During these visits a variety of measures will be collected, including blood samples, neurological and physical exams, patient reported outcomes on stiffness, spasms, depression, and suicide risk.",[145],"Stiff-Person Syndrome",[145,147],"Efgartigimod","2025-04-10",{"date":150,"type":37},"2025-04-11",{"date":152,"type":21},"2025-04-01",{"date":154,"type":21},"2027-12-31",{"name":156,"class":101},"University of South Florida",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":164,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":167,"conditions":168,"keywords":177,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":186,"locationsCount":73},"100554663","biomarkers-in-autoimmune-disease-of-nervous-system-100554663","NCT06502015","Biomarkers in Autoimmune Disease of Nervous System","Biomarkers of Neurological Autoimmune Diseases","Inclusion Criteria:\n\n* Clinical diagnosis with autoinflammatory diseases of the nervous system, including: Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy(IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), ect al.\n* sex and age-matched healthy individuals\n\nExclusion Criteria:\n\n* Known history of primary immunodeficiency (innate or acquired).\n* Patients with severe central nervous system, pulmonary, or other systemic infections.\n* Patients with secondary central nervous system demyelinating lesions, such as those caused by vasculitis, systemic lupus erythematosus, and Sjögren's syndrome.\n* Patients with vascular (including hemorrhagic and ischemic), hereditary metabolic, neoplastic, or toxic diseases.\n* Pregnant or lactating women.",true,{"count":166,"type":21},50000,"Neurological autoimmune diseases are a group of disorders characterized by the abnormal immune response attacking the nervous system, including the brain, spinal cord and peripheral nerves. These diseases exhibit high heterogeneity, diverse clinical presentations, and are challenging to diagnose and manage due to a lack of effective treatments. In this study, the investigators will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy (IIM), and multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). Through this study, the investigators aim to discover biomarkers with high sensitivity, specificity, and stability, which can support early diagnosis, disease monitoring, and personalized treatment for neurological autoimmune diseases, thereby improving the quality of life and prognosis for patients.",[169,170,60,171,172,89,145,173,174,175,176],"Autoimmune Diseases of the Nervous System","Neuromyelitis Optica Spectrum Disorder","Guillain-Barre Syndrome","Acute Disseminated Encephalomyelitis","Myasthenia Gravis","Chronic Inflammatory Demyelinating Polyradiculoneuropathy","Idiopathic Inflammatory Myopathies","Autoimmune Diseases",[178,169,179],"Biomarker","Immune cell","2024-11-17",{"date":182,"type":37},"2024-11-20",{"date":184,"type":37},"2024-07-31",{"date":127,"type":21},{"name":187,"class":101},"Tongji Hospital"]