[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"progressive-multifocal-leukoencephalopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:progressive-multifocal-leukoencephalopathy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,70,94,118],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100632235","phase-2-intravenous-brincidofovir-as-an-antiviral-for-treatment-of-progressive-multifocal-leukoencephalopathy-a-pilot-study-100632235",false,"NCT07511049","Intravenous Brincidofovir as an Antiviral for Treatment of Progressive Multifocal Leukoencephalopathy: A Pilot Study","Safety and Tolerability of Intravenous Brincidofovir as an Antiviral for Treatment of Progressive Multifocal Leukoencephalopathy: A Pilot Study","* INCLUSION CRITERIA:\n* Able to provide informed consent\n* Stated willingness to comply with study procedures and to participate for the duration of the study including follow-up\n* Actively progressing, clinically definite or probable PML (2013 AAN Consensus Diagnostic Criteria)\n* Positive PCR for JCPyV in CSF\n* Age 18 or older\n* Medically stable and able to tolerate travel to NIH\n* Participants of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study\n\nEXCLUSION CRITERIA:\n\n* ALT or AST \\> 5 x the ULN, total bilirubin \\> 3 mg\u002FdL (SI: \\>51 micromol\u002FL), or spontaneous prothrombin time-international normalized ratio (PT-INR) \\> 2 x ULN within 7 days prior to Day 1\n* An estimated glomerular filtration rate of \\\u003C 30 mL\u002Fmin within 7 days prior to Day 1\n* Hypersensitivity to CDV or to BCV or its formulation excipients, or prior intolerance to these agents that, in the opinion of the investigator, would pose an unacceptable safety risk.\n* Active CNS disease other than PML that, in the opinion of the investigator, would confound study assessments or pose an unacceptable safety risk.\n* Contraindication to MRI (including cardiac pacemakers and some infusion pumps, other metallic implants, metallic foreign objects)\n* Medical contraindication to LP\n* Positive pregnancy test or nursing","ALL","18 Years","99 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nProgressive multifocal leukoencephalopathy (PML) is a rare and often fatal brain infection caused by the JC virus. The JC virus is common. More than half of adults have been exposed to it. Most people do not get sick from the JC virus, but in people with weakened immune systems, it can cause PML. Brincidofovir (BCV) is an antiviral drug approved to treat smallpox. Researchers want to know if it can help people with PML.\n\nObjective:\n\nTo test BCV in people with PML.\n\nEligibility:\n\nPeople aged 18 years or older with PML.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have an imaging scan of the brain with contrast dye. They will have a lumbar puncture (spinal tap): A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord.\n\nBCV will be given through a tube attached to a needle inserted into a vein. Participants will receive the drug 2 times a week for 4 weeks (this is 1 cycle). If the drug is helping them, they may have up to 3 drug cycles (12 weeks).\n\nImaging scans, spinal taps, and other tests will be repeated after every 4 weeks of treatment. Participants will have 6 follow-up visits in 1 year after treatment ends. The imaging scan, spinal tap, and other tests will be repeated at each visit.",[27],"Progressive Multifocal Leukoencephalopathy",[29,30],"Safety and Tolerability of Intravenous Brincidofovir","safety, tolerability, brincidofovir, PML, JCV","RECRUITING","2026-06-25",{"date":34,"type":35},"2026-06-26","ACTUAL",{"date":37,"type":35},"2026-06-05",{"date":39,"type":21},"2029-12-31",{"name":41,"class":42},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":4,"leadSponsor":69,"locationsCount":43},"100188552","natural-history-study-of-progressive-multifocal-leukoencephalopathy-pml-100188552","NCT01730131","Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)","* PML Patients\n\nINCLUSION CRITERIA:\n\n1. Suspected or confirmed PML\n2. MRI compatible with PML\n3. Able to participate in the studies and follow-up required by the protocol\n4. At least 2 years old\n\nEXCLUSION CRITERIA:\n\n1. Significant condition, which in the judgment of the principal investigator, would make participation in the diagnostic and research parts of evaluation impossible or risky\n2. Medical contraindication to MRI (i.e., devices such as a cardiac pacemaker or infusion pump, other metallic implants, metallic foreign objects, body piercings that cannot be removed)\n3. Pregnancy\n4. Inability to provide informed consent, either directly or via legally authorized representative (LAR)\n5. Unwillingness to consent for collection of biological samples or their cryopreservation\n\nControl Patients at Risk for PML\n\nINCLUSION CRITERIA:\n\n1. Able to participate in the studies and follow-up required by the protocol\n2. At least 2 years old\n3. Impaired immune function from any cause and considered at risk for PML (i.e.-history of hematological malignancy, chronic inflammatory disease, history of treatment with immune suppressive or immunomodulatory therapies, primary or acquired immunodeficiency syndromes)\n\nEXCLUSION CRITERIA:\n\n1. Significant condition, which in the judgment of the principal investigator, would make participation in the diagnostic and research parts of evaluation impossible or risky\n2. Medical contraindication to MRI (i.e., devices such as a cardiac pacemaker or infusion pump, other metallic implants, metallic foreign objects, body piercings that cannot be removed)\n3. Pregnancy\n4. Inability to provide informed consent, either directly or via legally authorized representative (LAR)\n5. Unwillingness to consent for collection of biological samples or their cryopreservation\n\nHealthy Volunteers\n\nINCLUSION CRITERIA:\n\n1. Able to participate in the studies and follow-up required by the protocol\n2. At least 18 years old\n\nEXCLUSION CRITERIA:\n\n1. Impaired immune function (i.e.-history of hematological malignancy, chronic inflammatory disease, history of treatment with immune suppressive or immunomodulatory therapies, primary or acquired immunodeficiency syndromes)\n2. Significant condition, which in the judgment of the principal investigator, would make participation in the diagnostic and research parts of evaluation impossible or risky\n3. Medical contraindication to MRI (i.e., devices such as a cardiac pacemaker or infusion pump, other metallic implants, metallic foreign objects, body piercings that cannot be removed)\n4. Pregnancy\n5. Inability to provide informed consent, either directly or via legally authorized representative (LAR)\n6. Unwillingness to consent for collection of biological samples or their cryopreservation",true,"2 Years","120 Years",{"count":54,"type":21},700,"OBSERVATIONAL","Background:\n\n\\- Progressive multifocal leukoencephalopathy (PML) is a severe viral infection of the brain. It is caused by JC virus. Many people have this virus in their bodies all their life, but it is usually kept in check by their immune system. If the immune system does not work right because of a disease or medication, the virus becomes active and can damage cells in the brain. Not much is known about PML or how it affects the immune system. Researchers want to study people with PML to better understand the natural history of the disease.\n\nObjectives:\n\n\\- To study the natural history of PML.\n\nEligibility:\n\n\\- Individuals at least 2 years of age who have PML.\n\nDesign:\n\n* Participants will be screened with a physical exam, medical history, and imaging studies.\n* Participants will have several visits to the National Institutes of Health Clinical Center. There will be an initial visit, monthly visits for the next 6 months, a 12-month visit, and possible visits afterward.\n* At the initial visit, participants will give blood, urine, and spinal fluid samples. They will also have neurological tests and imaging studies of the brain.\n* For the next five visits, participants will give blood and urine samples. They will also have neurological tests and imaging studies of the brain.\n* The 6-month and 12-month visits will repeat the tests from the initial visit.\n* Other optional procedures include bone marrow samples and skin biopsies. Additional blood tests and imaging studies may be performed.\n* Treatment will not be provided as part of this study.",[27],[59,60,61,62,63],"Encephalitis","Immune Reconstitution Syndrome","Human Immunodeficiency Virus","Multiple Sclerosis","Natural History","2026-06-23",{"date":66,"type":35},"2026-06-24",{"date":68,"type":35},"2012-11-08",{"name":41,"class":42},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":43},"100504525","phase-1-central-nervous-system-uptake-of-anti-cd8-t-cell-minibodies-in-multiple-sclerosis-and-progressive-multifocal-leukoencephalopathy-100504525","NCT05849467","Central Nervous System Uptake of Anti-CD8+ T Cell Minibodies in Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy","Central Nervous System Uptake of Anti-CD8+ T Cell Minibodies in Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy: A Pilot Study","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nMultiple Sclerosis Inclusion Criteria\n\n* Enrolled in the NINDS Natural History Study for MS (protocol 89-N-0045)\n* Able to understand, and willing to sign, a written, informed consent document.\n* Willing to comply with all study procedures and available for the duration of the study.\n* Male or female, aged \\>=18.\n* Diagnosis of MS according to the 2017 revision of the McDonald diagnostic criteria48 (in the presence or absence of a clinical relapse).\n\nPML Inclusion Criteria\n\n* Enrolled in the NINDS Natural History Study for PML (protocol 13-N-0017)\n* Able to understand and willing to sign a written, informed consent document\n* Willing to comply with all study procedures and available for the duration of the study.\n* Male or female, aged \\>=18.\n* Diagnosis of definite PML according to 2013 AAN Consensus Criteria49 or PML-IRIS based on clinical, radiological and laboratory evidence.\n\nPatients with Known or Suspected Neuroinflammatory Diseases and Evidence of Open BBB Inclusion Criteria\n\n-Clinical evaluation suggesting an inflammatory disorder of the central nervous system other than MS or PML. Other confirmed neuroinflammatory disorders may include -MOGAD, NMOSD, Behcet's syndrome, and neurosarcoidosis. Unconfirmed, though\n\nsuspected cases of neuroinflammation may also be included.\n\n* Recent brain MRI (within 1 month) with gadolinium enhancement indicating open BBB.\n* Able to understand and willing to sign a written, informed consent document.\n* Willing to comply with all study procedures and available for the duration of the study.\n* Male or female, aged \\>=18.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant or lactating.\n* Contraindications for MRI gadolinium contrast administration or 3T MRI.\n* History of, or current diagnosis with, concomitant medical or clinical conditions that would adversely affect participation in this study.\n* Weighs \\> 350 lb. (158 kg; weight limit for the scanner table) or is unable to fit within the MRI or PET imaging gantry.\n* Severe claustrophobia unresponsive to oral anxiolytics.\n* Has an alkaline phosphatase level greater than 2x ULN (unless known to have non-liver related disorder) OR AST greater than 1.5 x ULN OR ALT greater than 1.5 x ULN.\n* Has a total bilirubin \\>1.5X ULN, unless known to have elevated bilirubin due to nonliver related disorder or Gilbert s.\n* Creatinine clearance \\\u003C 60 mL\u002Fmin as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)\n* For females of reproductive potential: inability to use highly effective contraception for at least one month prior to screening and during study participation.",{"count":78,"type":21},15,[80],"PHASE1","Background:\n\nMultiple sclerosis (MS) and progressive multifocal leukoencephalopathy (PML) are disorders that affect the central nervous system (CNS). The CNS includes the brain, spinal cord, and optic nerves. Both diseases can cause muscle weakness and impair vision, speech, and coordination. Researchers are working to better understand how MS and PML affect the CNS.\n\nObjective: To test whether an experimental radioactive tracer (minibody) can help positron emission tomography (PET) scans detect certain immune cells in the CNS of people with MS and PML.\n\nEligibility:\n\nPeople aged 18 years and older with MS, other neuroinflammatory diseases with BBB leakage, or PML.\n\nDesign:\n\nParticipants will come to the clinic for at least 3 visits over 4 to 6 weeks.\n\nParticipants will undergo testing. They will have a physical and neurological exam. They will have blood tests and tests of their heart function. They will have a magnetic resonance imaging (MRI) scan of the brain. They may have a spinal tap: Their lower back will be numbed, and a needle will be inserted between the bones of the spine to withdraw fluid from around the spinal cord.\n\nMinibody is given through a tube with a needle placed in a vein in the arm. This takes 5 to 10 minutes. Participants will have heart function tests before and after receiving the minibody.\n\nParticipants may have a PET scan on the day of the Minibody and will return the next day for another PET scan. They will lie on a table that moves through a doughnut-shaped machine. This scan will take about 1 hour.\n\nParticipants with PML may opt to repeat the minibody infusion and the PET scan within 6 months.",[27,62,83],"Other Neuroinflammatory Diseases With BBB Leakage",[85,86],"89 Zr-Df-crefmirlimab","PET Imaging","2026-06-04",{"date":37,"type":35},{"date":90,"type":35},"2023-10-19",{"date":92,"type":21},"2030-12-01",{"name":41,"class":42},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":101,"maxAge":4,"enrollmentInfo":102,"targetDuration":104,"studyType":55,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":43},"100632348","observational-cohort-study-of-chronic-viral-infection-in-the-central-nervous-system-100632348","NCT07512518","Observational Cohort Study of Chronic Viral Infection in the Central Nervous System","Central Nervous System Chronic Viral Infections: A Cohort Study","Inclusion Criteria:\n\n1. Age \\> 14 years old.\n2. Confirmed diagnosis of chronic viral infection of the central nervous system (CNS).\n3. Signed informed consent. The diagnosis of Progressive Multifocal Leukoencephalopathy (PML) shall meet one of the following criteria:(1) Neuropathological diagnosis: Pathological examination of brain tissue shows demyelination, bizarre astrocytes, and enlarged oligodendroglial nuclei; immunohistochemical detection of JC virus (JCV) antigen.(2) Clinical + imaging + cerebrospinal fluid (CSF) diagnosis: Clinical manifestations of progressive neurological dysfunction; neuroimaging shows single or multiple asymmetric white matter lesions with large volume, mostly involving the U-fibers, and rare mass effect; detection of JC virus DNA in cerebrospinal fluid. Specific reference shall be made to the 2013 American Academy of Neurology (AAN) diagnostic criteria.\n\nFor the diagnosis of other chronic viral infections of the central nervous system, the clinical manifestations shall be consistent with the characteristics of the relevant diseases, and the relevant viral DNA shall be detected in the cerebrospinal fluid.\n\nThe diagnosis of all cases must be independently confirmed by two physicians from the Encephalitis Professional Group, Department of Neurology, Peking Union Medical College Hospital, with consistent diagnostic results, to be included in the study. For cases with inconsistent diagnoses, the two physicians shall conduct consultations to reach a consensus. Patients with unreached diagnostic consensus shall not be included in the study.\n\nExclusion Criteria:\n\n1. Presence of lumbar puncture contraindications, making it impossible to collect cerebrospinal fluid.\n2. The attending physician and the researcher consider that the detection of virus in cerebrospinal fluid cannot explain the patient's clinical manifestations.\n3. Inability to complete 1-year follow-up.","14 Years",{"count":103,"type":21},66,"1 Year","This research team intends to conduct a real-world cohort study of chronic CNS viral infections represented by PML, to evaluate whether administration of immune checkpoint inhibitors improves long-term outcomes in this patient population.Patients with prior follow-up will be enrolled into a retrospective\u002Fprospective ambidirectional cohort, and newly diagnosed patients will be enrolled into a prospective cohort.",[27,107],"Immune Checkpoint Inhibitors","2026-03-30",{"date":110,"type":35},"2026-04-06",{"date":112,"type":35},"2023-02-20",{"date":114,"type":21},"2030-10-25",{"name":116,"class":117},"Peking Union Medical College Hospital","OTHER",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100537336","phase-2-pembrolizumab-in-progressive-multifocal-leukoencephalopathy-pml-in-immunocompromised-patients-without-hiv-infection-100537336","NCT06276504","Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection","PENALTY","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Diagnosis of definite PML since less than 2 months according to American Academy of Neurology\n3. Presence of JCV in the CSF in the last CSF sampling.\n4. Signed informed consent (from the patient, or if unable to consent, from a surrogate)\n5. For women of childbearing potential: negative serum or urine b-HCG test and agree to use a highly effective contraception methods during 8 months (i.e. until 6 months after end of experimental treatment)\n\nExclusion Criteria:\n\n1. Patients in whom immune reconstitution is achievable (HIV infection - Multiple sclerosis - Auto-immune and inflammatory diseases)\n2. Patients who have received solid organ transplantation\n3. Hypersensitivity to the active substance or to any of the excipients\n4. Life expectancy less than 1 month\n5. Pregnancy or lactating women or planning birth during the study period\n6. Having previously been treated by anti-PD1mAb\n7. Patient receiving IL-2 or IL-7 for the treatment of PML at inclusion\n8. Patient whose weight is \\> 100kg\n9. Participation in other interventional study \\[a patient already included in another interventional study for which the treatment can lead to an immunodepression can be included if:\n\n   * the investigational treatment has been completed and there is no risk of drug interaction with the administration of Pembrolizumab as defined in PENALTY study\n   * if this does not alter the study's ability to evaluate the effect of Pembrolizumab in terms of safety and efficacy (from the investigator's point of view)\\]\n10. Patient without national health insurance, and patient on AME (state medical aid)\n11. Patient under guardianship or curatorship\n12. Patient deprived of their liberty by a judicial or administrative decision",{"count":126,"type":21},33,[24,128],"PHASE3","This study aims to assess the efficacy and safety of pembrolizumab in immunocompromised patients with progressive multifocal leukoencephalopathy (PML). This phase II, multicenter, single-arm study includes patients with an underlying cause of immunosuppression hardly reversible, i.e. not the patients with HIV nor those receiving biologics for chronic inflammatory diseases. Patients will receive intravenous pembrolizumab (2 mg\u002Fkg, maximum 200 mg) at month 0, 1 and 2 (total of three doses). The primary endpoint will be achieving at least one negative result of JCV viral load in cerebrospinal fluid (CSF) within the M0 to M3 period.",[27],[27,132,133],"Checkpoint inhibitors","Pembrolizumab","NOT_YET_RECRUITING","2024-02-21",{"date":137,"type":35},"2024-02-26",{"date":139,"type":21},"2024-04",{"date":141,"type":21},"2028-04",{"name":143,"class":117},"Assistance Publique - Hôpitaux de Paris",3]