New hope for Hard-to-Treat seizures: phase 3 trial launches
NCT ID NCT06719141
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 5 times
Summary
This study tests an experimental drug called LP352 to see if it can safely reduce seizures in children and adults with developmental and epileptic encephalopathies (DEE), a group of severe epilepsy syndromes. About 320 participants will receive either LP352 or a placebo, and researchers will track changes in seizure frequency over several months. The goal is to find a better treatment option for people whose seizures are not controlled by current medications.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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367 people
The number who actually took part.
- Started
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Nov 2024
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) must fulfill all of the following criteria: * Onset of seizures at ≤8 years old * History of tonic/tonic-atonic seizures plus at least 1 of the following seizure type(s): atypical absence, atonic, myoclonic, focal impaired awareness, generalized tonic-clonic, nonconvulsive status epilepticus, or epileptic spasms * Presence of developmental plateauing or regression * History of electroencephalogram (EEG) showing generalized slow (\<2.5 Hertz \[Hz\]) spike-and-wave complexes * Participants who are characterized as having DEE (Other) must fulfill all of the following criteria: * Does not meet criteria for LGS * Onset of seizures at ≤5 years old * Presence of developmental plateauing or regression * History of multiple seizure types * History of interictal EEG background showing diffuse or multifocal slowing (with or without epileptiform activity) * The participant has a current occurrence of at least 1 of the following countable motor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal/leg involvement, focal motor (including hemiclonic), and focal to bilateral tonic-clonic. * The participant has demonstrated an average of at least 4 countable motor seizures per month for each of the 3 months prior to Screening. * The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening. * The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study. * The participant must be willing and able to provide written informed consent; in instances where the participant is unable to provide consent, an appropriate legal representative. Exclusion Criteria: * The participant has a diagnosis of Dravet Syndrome (DS) or has a mutation of the Sodium channel protein type 1 subunit alpha (SCN1A) gene consistent with DS. * The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening. * The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing. * The participant has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures. * The participant is receiving exclusionary medications. * The participant is currently using any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or contains ≥50% Delta-9-tetrahydrocannabinol (THC). * The participant has unstable, clinically significant neurologic (other than the disease being studied; eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results. * The participant is unable or unwilling to comply with any of the study requirements or timelines.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AP-HM- Hôpital de La Timone
Marseille, 13005, France
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AP-HP - Hôpital universitaire Necker-Enfants malades
Paris, 75015, France
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AP-HP - Hôpital universitaire Robert-Debré
Paris, 75019, France
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Arkansas Children's Hospital - Cardiology Clinic
Little Rock, Arkansas, 72202-3500, United States
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Austin Hospital
Heidelberg, Victoria, 3084, Australia
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Azienda Ospedaliera Universitaria Integrata Verona - Centro Fibrosi Cistica di Verona (CFC Verona)
Verona, 37126, Italy
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Azienda Ospedaliero-Universitaria Meyer - Ospedale dei Bambini
Florence, Tuscany, 50139, Italy
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BC Children's Hospital (British Columbia Children's Hospital)
Vancouver, British Columbia, V6H 3V4, Canada
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Barnabas Health - Institute of Neurology and Neurosurgery
Livingston, New Jersey, 07039-5817, United States
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Bernu Kliniska Universitates Slimnica (BKUS) (University Children's Hospital)
Riga, LV-1004, Latvia
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Capital Medical University-Beijing Children's Hospital
Beijing, Beijing Municipality, 100045, China
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Cardiff and Vale University Health Board - University Hospital of Wales (UHW) - Noah's Ark Childr...
Cardiff, East Wales, CF14 4XW, United Kingdom
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Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Psychiatrie
Toulouse, Occitanie, 31059, France
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Centre Hospitalier Universitaire de Lyon - Hôpital Pierre Wertheimer
Bron, 69500, France
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Centro Hospitalar Universitario de Santo Antonio - Centro Materno Infantil do Norte (CMIN)
Porto, 4050, Portugal
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Child Neurology Consultants of Austin - Austin
Austin, Texas, 78731-3157, United States
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Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, 30329-2311, United States
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Children's Hospital Colorado - Heart Institute
Aurora, Colorado, 80045-7106, United States
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Children's Hospital Los Angeles (CHLA)
Los Angeles, California, 90027-6062, United States
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Children's National Hospital - Children's National Heart Center
Washington D.C., District of Columbia, 20010-2916, United States
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Chu de Rennes - Centre d'Evaluation et de Traitement de la Douleur de l'Adulte et de l'Enfant
Villejuif, Île-de-France Region, 94800, France
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Clinical Center Kragujevac
Kragujevac, Sumadijski Okrug, 34000, Serbia
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Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, 83702-5029, United States
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Cook Children's Jane and John Justin Neurosciences Center
Fort Worth, Texas, 76104-2710, United States
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Dokkyo Medical University Hospital
Mibu-Machi, Tochigi, 321-0293, Japan
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Epilepsie-Zentrum Bodensee
Ravensburg, 88214, Germany
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Epilepsiezentrum Kleinwachau gemeinnützige GmbH
Radeberg, Saxony, 01454, Germany
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Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP)
São José do Rio Preto, São Paulo, 15090-000, Brazil
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, 20133, Italy
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Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico
Pavia, 27100, Italy
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Fudan University - Children's Hospital
Shanghai Shi, Shanghai Municipality, 201102, China
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Fukuoka Children's Hospital (FCH)
Fukuoka, Fukuoka, 813-0017, Japan
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Gesellschaft fuer Epilepsieforschung e.V.
Bielefeld, North Rhine-Westphalia, 33617, Germany
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Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3JH, United Kingdom
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Guangzhou Medical University-The Second Affiliated Hospital
Guangzhou, Guangdong, 510260, China
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Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
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Hospital Infantil Universitario Nino Jesus (HIUNJS)
Madrid, 28009, Spain
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Hospital Pediátrico de Coimbra
Coimbra, 3000-602, Portugal
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Hospital Regional Universitario de Malaga - Hospital General
Málaga, 29010, Spain
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Hospital Ruber Internacional
Madrid, 28034, Spain
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Hospital Sant Joan de Deu Barcelona (HSJDB)
Esplugues de Llobregat, Barcelona, 08950, Spain
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Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
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Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, 46026, Spain
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Hospital Universitario Vithas Madrid La Milagrosa
Madrid, 28010, Spain
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Hospital Universitario de Navarra
Pamplona, Navarre, 31008, Spain
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Hospital Vithas Malaga
Málaga, 29016, Spain
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Hospital de la Santa Creu I Sant Pau
Barcelona, 8041, Spain
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Hôpital Roger Salengro
Lille, Nord, 59000, France
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Hôpital de Hautepierre - Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098, France
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Institut za Zdravstvenu Zastitu Majke i Deteta Srbije Dr Vukan Cupic
Belgrade, Beograd, 11070, Serbia
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Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
Mexico City, Mexico City, 04530, Mexico
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Instituto de Neurologia de Curitiba (INC)
Curitiba, Paraná, 81210-310, Brazil
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International University of Health and Welfare - Narita Hospital
Narita-shi, Chiba, 286-8520, Japan
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Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare
Genoa, 16147, Italy
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Le Bonheur Children's Hospital - Outpatient Center
Memphis, Tennessee, 38105-4625, United States
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London Health Sciences Centre (LHSC)
London, Ontario, N6A 5W9, Canada
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Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114, United States
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Mayo Clinic - Children's Center - Rochester
Rochester, Minnesota, 55905-0001, United States
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Mid-Atlantic Epilepsy and Sleep Center - Bethesda
Bethesda, Maryland, 20817-1844, United States
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Moinhos de Vento Hospital (Hospital Moinhos de Vento) (HMV)
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
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MultiCare Health System
Tacoma, Washington, 98415-0299, United States
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NHS Greater Glasgow and Clyde-Glasgow Clinical Research Facility - Queen Elizabeth University Hos...
Glasgow, South Western Scotland, G51 4TF, United Kingdom
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NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, 32561-4495, United States
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NYU Langone Health-NYU Comprehensive Epilepsy Center
New York, New York, 10016-4852, United States
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National Center of Neurology and Psychiatry-National Center Hospital
Kodaira-shi, Tokyo-To, 187-8551, Japan
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National Hospital Organization Nishi-Niigata Chuo National Hospital
Niigata, 950-2074, Japan
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National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, 420-0953, Japan
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Nicklaus Children's Hospital (Miami Children's Hospital)
Miami, Florida, 33155-3009, United States
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Northeast Regional Epilepsy Group - Morristown
Morristown, New Jersey, 07960-6092, United States
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Northwestern Memorial Hospital
Chicago, Illinois, 60611-2908, United States
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Northwestern University - Ann & Robert H. Lurie Children's Hospital of Chicago - Center for Cance...
Chicago, Illinois, 60611-2991, United States
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Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
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Oregon Health & Science University - Blood Brain Barrier and Neuro-Oncology Program
Portland, Oregon, 97239-3098, United States
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Osaka City General Hospital
Osaka, Osaka, 534-0021, Japan
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Ospedale Pediatrico Bambino Gesu - Gianicolo
Rome, 00165, Italy
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Pediatric Epilepsy & Neurology Specialists (PENS)
Tampa, Florida, 33609-4191, United States
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Peking University First Hospital (Beida Hospital)
Beijing, Beijing Municipality, 100034, China
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Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Instituto Do Cerebro Do Rio Grand...
Porto Alegre, Rio Grande do Sul, 90610-970, Brazil
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Prince of Wales Hospital (POWH)
Randwick, New South Wales, 2031, Australia
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Queensland Children's Hospital (Lady Cilento Children's Hospital)
Brisbane, Queensland, 4101, Australia
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Rare Disease Research, LLC. (RDR)
Atlanta, Georgia, 30329, United States
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Research Institute of Orlando LLC
Orlando, Florida, 32806, United States
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Royal Brisbane and Women's Hospital (RBWH)
Brisbane, Queensland, 4006, Australia
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Saitama Prefectural Children's Medical Center
Saitama-shi, Saitama, 330-8777, Japan
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Shenzhen Children's Hospital
Shenzhen Shi, Guangdong, 518026, China
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Stanford University - Stanford School of Medicine - Pulmonary and Cystic Fibrosis Center
Palo Alto, California, 94304-1511, United States
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Sydney Children's Hospital - Randwick
Randwick, New South Wales, 2031, Australia
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The Alfred Hospital
Melbourne, Victoria, 3004, Australia
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The Children's Hospital-Westmead - Heart Centre for Children
Westmead, New South Wales, 2145, Australia
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The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8, Canada
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The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)
Newcastle upon Tyne, North East, NE1 4LP, United Kingdom
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The Royal Children's Hospital (RCH) Melbourne
Parkville, Victoria, 3052, Australia
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The University of Texas Medical School at Houston - UT Gastroenterology
Houston, Texas, 77030-1517, United States
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UCSF Benioff Children's Hospitals - San Francisco
San Francisco, California, 94158, United States
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Unidade Local de Saude Santa Maria, E.P.E (ULSSM)
Lisbon, 1649-035, Portugal
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Universidade Estadual de Campinas (UNICAMP) - Hospital das Clinicas (HC)
Campinas, São Paulo, 13083-888, Brazil
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Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP) - Inst...
São Paulo, 05403-903, Brazil
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Universidade de Sao Paulo (USP)-Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto ...
Ribeirão Preto, São Paulo, 14051-260, Brazil
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Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario A Gemelli - Centro pe...
Rome, 00168, Italy
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Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Kiel - Klinik fuer Psychosomatik und Psy...
Kiel, Schleswig-Holstein, 24105, Germany
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Universitair Medisch Centrum Utrecht - Polikliniek Oogheelkunde
Utrecht, 3584 CX, Netherlands
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Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Antwerp, 2650, Belgium
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Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Flemish Brabant, 3000, Belgium
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University College London Hospitals NHS Foundation Trust (UCLH)
London, NW1 2PG, United Kingdom
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University Health Network-Toronto Western Hospital - Krembil Neuroscience Centre (KNC)
Toronto, Ontario, M5T 2S8, Canada
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University Hospital Southampton NHS Foundation Trust-Southampton General Hospital (SGH)
Southampton, South East, SO16 6YD, United Kingdom
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University Hospitals Birmingham (UHB) NHS Foundation Trust - Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2WB, United Kingdom
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University of Belgrade-Faculty of Medicine - Clinic of Neurology and Psychiatry for Children and ...
Belgrade, Beograd, 112112, Serbia
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University of California Los Angeles (UCLA) - David Geffen School of Medicine - Global Health Pro...
Los Angeles, California, 90095, United States
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University of Iowa Health Care Medical Center (University of Iowa Hospitals & Clinics)
Iowa City, Iowa, 52242-1009, United States
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University of Miami Medical Group (UMMG)
Miami, Florida, 33136-2117, United States
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University of South Florida (USF) - Tampa Campus
Tampa, Florida, 33620, United States
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Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
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Universitätsklinikum Frankfurt - Klinikum der Goethe-Universität
Frankfurt am Main, Hesse, 60596, Germany
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Univerzitetski Klinicki Centar Srbije - Klinika za Neurologiju
Belgrade, Beograd, 11000, Serbia
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Wuhan Children's Hospital
Wuhan, Hubei, 430016, China
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