Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT05605951
Status:
RECRUITING
Last Update Posted:
2022-11-04
First Post:
2022-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Optic Neuritis Network: an International Study That Invesitages Subjects With a First-ever Episode of Acute Inflammation of the Optic Nerve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D000098542', 'term': 'Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease'}, {'id': 'D009902', 'term': 'Optic Neuritis'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2022-10-23', 'studyFirstSubmitQcDate': '2022-10-31', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to investigate whether MS-ON, AQP4-IgG+ON and MOG-IgG+ON patients treated with early high-dose corticosteroids for visual loss have better visual outcomes and QoL than those with late treatment.', 'timeFrame': 'Six months follow-up', 'description': 'visual acuity'}], 'secondaryOutcomes': [{'measure': 'Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment.', 'timeFrame': 'Six months follow-up', 'description': 'RNFL'}, {'measure': 'Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment.', 'timeFrame': 'Six months follow-up', 'description': 'MRI lesion score'}, {'measure': 'Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment.', 'timeFrame': '12 months follow-up', 'description': 'MRI lesion score'}, {'measure': 'Visual and structural outcomes of MS-ON in patients treated with high-dose corticosteroid-therapy with oral prednisone taper vs. without taper as standard of care.', 'timeFrame': '12 months follow-up', 'description': 'RNFL'}, {'measure': 'Diagnostic and prognostic value of biomarker levels (NfL, GFAP) and associations with visual pathway damage (MRI- and OCT-based) in the acute stage and during follow-up.', 'timeFrame': 'Acute stage (onset)', 'description': 'NfL (pg/ml)'}, {'measure': 'Diagnostic and prognostic value of biomarker levels (NfL, GFAP) and associations with visual pathway damage (MRI- and OCT-based) in the acute stage and during follow-up.', 'timeFrame': 'Acute stage (onset)', 'description': 'GFAP (pg/ml)'}, {'measure': 'Diagnostic and prognostic value of biomarker levels (NfL, GFAP) and associations with visual pathway damage (MRI- and OCT-based) in the acute stage and during follow-up.', 'timeFrame': 'Six months follow-up', 'description': 'NfL (pg/ml)'}, {'measure': 'Diagnostic and prognostic value of biomarker levels (NfL, GFAP) and associations with visual pathway damage (MRI- and OCT-based) in the acute stage and during follow-up.', 'timeFrame': 'Six months follow-up', 'description': 'GFAP (pg/ml)'}, {'measure': 'Diagnostic and prognostic value of biomarker levels (NfL, GFAP) and associations with visual pathway damage (MRI- and OCT-based) in the acute stage and during follow-up.', 'timeFrame': '12 months follow-up', 'description': 'NfL (pg/ml)'}, {'measure': 'Diagnostic and prognostic value of biomarker levels (NfL, GFAP) and associations with visual pathway damage (MRI- and OCT-based) in the acute stage and during follow-up.', 'timeFrame': '12 months follow-up', 'description': 'GFAP (pg/ml)'}, {'measure': 'Characterization of MOG-IgG and AQP4-IgG levels and compartmentalisation (serum vs. CSF, using simultaneous paired samples) and associated risks for subsequent relapses in subjects with AQP4-IgG+ON and MOG-IgG+ON.', 'timeFrame': 'Acute stage (onset)', 'description': 'MOG-IgG ratio'}, {'measure': 'Characterization of MOG-IgG and AQP4-IgG levels and compartmentalisation (serum vs. CSF, using simultaneous paired samples) and associated risks for subsequent relapses in subjects with AQP4-IgG+ON and MOG-IgG+ON.', 'timeFrame': 'Acute stage (onset)', 'description': 'AQP4-IgG ratio'}, {'measure': 'Characterization of MOG-IgG and AQP4-IgG levels and compartmentalisation (serum vs. CSF, using simultaneous paired samples) and associated risks for subsequent relapses in subjects with AQP4-IgG+ON and MOG-IgG+ON.', 'timeFrame': 'Six months follow-up', 'description': 'MOG-IgG IgG ratio'}, {'measure': 'Characterization of MOG-IgG and AQP4-IgG levels and compartmentalisation (serum vs. CSF, using simultaneous paired samples) and associated risks for subsequent relapses in subjects with AQP4-IgG+ON and MOG-IgG+ON.', 'timeFrame': '12 months follow-up', 'description': 'AQP4-IgG ratio'}, {'measure': 'Diagnostic value of OCT markers (e.g. increased pRNFL) for diagnosis of MS, NMOSD, and MOGAD.', 'timeFrame': 'Acute stage (onset)', 'description': 'pRNFL'}, {'measure': 'Diagnostic value of OCT markers (e.g. increased pRNFL) for diagnosis of MS, NMOSD, and MOGAD.', 'timeFrame': 'Six months follow-up', 'description': 'pRNFL'}, {'measure': 'Prognostic value of OCT markers (e.g. increased pRNFL) for the visual outcome at 1-year follow-up.', 'timeFrame': '12 months follow-up', 'description': 'pRNFL'}, {'measure': 'Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS.', 'timeFrame': 'Acute stage (onset)', 'description': 'OCT markers'}, {'measure': 'Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS.', 'timeFrame': 'Six months follow-up', 'description': 'OCT markers'}, {'measure': 'Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS.', 'timeFrame': '12 months follow-up', 'description': 'OCT markers'}, {'measure': 'Diagnostic value of early clinical variables (i.e. visual loss and pain patterns).', 'timeFrame': 'Acute stage (onset)', 'description': 'pain intensity'}, {'measure': 'Diagnostic value of early clinical variables (i.e. visual loss and pain patterns).', 'timeFrame': 'Six months follow-up', 'description': 'pain intensity'}, {'measure': 'Diagnostic value of early clinical variables (i.e. visual loss and pain patterns).', 'timeFrame': '12 months follow-up', 'description': 'pain intensity'}, {'measure': 'Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.', 'timeFrame': 'Six months follow-up', 'description': 'NEI-VFQ-Score'}, {'measure': 'Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.', 'timeFrame': '12 months follow-up', 'description': 'NEI-VFQ-Score'}, {'measure': 'Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.', 'timeFrame': 'Six months follow-up', 'description': 'BDI-II Score'}, {'measure': 'Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.', 'timeFrame': '12 months follow-up', 'description': 'BDI-II Score'}, {'measure': 'Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.', 'timeFrame': 'Six months follow-up', 'description': 'EuroQol 5-Dimension EQ-5D-index'}, {'measure': 'Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.', 'timeFrame': '12 months follow-up', 'description': 'EuroQol 5-Dimension EQ-5D-index'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Demyelinating Diseases', 'Multiple Sclerosis', 'Neuromyelitis Optica Spectrum Disorder Attack', 'Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease', 'Optic Neuritis']}, 'referencesModule': {'references': [{'pmid': '36908609', 'type': 'DERIVED', 'citation': 'Asseyer S, Asgari N, Bennett J, Bialer O, Blanco Y, Bosello F, Camos-Carreras A, Carnero Contentti E, Carta S, Chen J, Chien C, Chomba M, Dale RC, Dalmau J, Feldmann K, Flanagan EP, Froment Tilikete C, Garcia-Alfonso C, Havla J, Hellmann M, Kim HJ, Klyscz P, Konietschke F, La Morgia C, Lana-Peixoto M, Leite MI, Levin N, Levy M, Llufriu S, Lopez P, Lotan I, Lugaresi A, Marignier R, Mariotto S, Mollan SP, Ocampo C, Cosima Oertel F, Olszewska M, Palace J, Pandit L, Peralta Uribe JL, Pittock S, Ramanathan S, Rattanathamsakul N, Saiz A, Samadzadeh S, Sanchez-Dalmau B, Saylor D, Scheel M, Schmitz-Hubsch T, Shifa J, Siritho S, Sperber PS, Subramanian PS, Tiosano A, Vaknin-Dembinsky A, Mejia Vergara AJ, Wilf-Yarkoni A, Zarco LA, Zimmermann HG, Paul F, Stiebel-Kalish H. The Acute Optic Neuritis Network (ACON): Study protocol of a non-interventional prospective multicenter study on diagnosis and treatment of acute optic neuritis. Front Neurol. 2023 Feb 24;14:1102353. doi: 10.3389/fneur.2023.1102353. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to longitudinally investigating subjects with inaugural acute optic neuritis (ON).\n\nThe main questions it aims to answer are:\n\n* Does the time to corticosteroid treatment affect the visual outcome at 6 months in subjects with acute multiple sclerosis (MS)-, aquaporin 4-IgG positive (AQP4-IgG+) and myelin-oligodendrocyte-glycoprotein-IgG positive (MOG-IgG+) ON?\n* How differ clinical, structural, and laboratory biomarkers in subjects with acute ON, including clinical isolated syndrome (CIS), MS-ON, AQP4-IgG+ON, MOG-IgG+ON and seronegative non-MS-ON? Participants will undergo\n* clinical examination, including clinical history, neurovisual and neurological tests\n* serum and cerebrospinal fluid examination\n* optical coherence tomography (OCT)\n* magnetic resonance imaging (MRI)\n* assessment of depression, pain, quality of life through validated questionnaires Researchers will compare subjects with MS-ON, AQP4-IgG+ON, MOG-IgG+ON and other ON (CIS, seronegative non-MS-ON) to detect diagnostic and predictive markers for the disease course.', 'detailedDescription': 'The Acute Optic Neuritis Network (ACON) is a global cooperation of currently 26 academic centers longitudinally investigating subjects with inaugural acute optic neuritis (ON). ON often occurs at presentation of multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD) and myelin-oligodendrocyte-glycoprotein (MOG) antibody-associated disease (MOGAD). The recommended treatment of high-dose corticosteroids for ON is based on a North-American study population, which did not address treatment timing, or antibody serostatus. The ACON study is primarily designed to investigate the effect of time to high-dose corticosteroid treatment on 6-month visual outcomes in ON.\n\nAll patients presenting within 30 days of inaugural ON will be enrolled. For primary analysis, patients will subsequently be assigned either into the MS-ON, aquaporin-4-IgG positive ON (AQP4-IgG+ON) or MOG-IgG positive ON (MOG-IgG+ON) group and then further sub-stratified according to the number of days from onset of visual loss to high-dose corticosteroids. The primary outcome measure will be high-contrast best-corrected visual acuity (HC-BCVA) at 6 months. Additionally, multimodal data will be collected in subjects with any ON (CIS-ON, MS-ON, AQP4-IgG+ON or MOG-IgG+ON and seronegative non-MS-ON), excluding infectious and granulomatous ON. Secondary outcomes include: optical coherence tomography (OCT) and magnetic resonance imaging (MRI) measurements, serum and cerebrospinal fluid (CSF) biomarkers (AQP4- and MOG-IgG levels; neurofilament; glial fibrillary protein), questionnaires (headache, visual function in daily routine, depression, and quality of life) at presentation, at 6- and 12-months follow-up. Data will be collected from 22 academic hospitals from Africa, Asia, the Middle East, Europe, North America, South America, Australia and Europe. Planned recruitment consists of 100 MS-ON, 50 AQP4-IgG+ON and 50 MOG-IgG+ON.\n\nThis prospective, multimodal data collection will assess the potential value of early high-dose corticosteroid treatment, investigate the interrelations between functional impairments and structural changes, and evaluate the diagnostic yield of laboratory biomarkers. This analysis has the ability to substantially improve treatment strategies and accuracy of diagnostic stratification in acute demyelinating ON.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'At least 300 patients with acute ON will be screened for study eligibility. We will include only inaugural ON patients. Subjects presenting for the first time with isolated ON or ON with additional demyelinating syndromes, e.g. myelitis or acute disseminated encephalomyelitis (ADEM) occurring within 30 days of the acute ON will be included. Patients with prior soft symptoms which can retrospectively be considered to be a demyelinating manifestation will be included, excluding patients with a prior demyelinating diagnosis. The prevalence of MS-, AQP4-IgG+ON and MOG-IgG+ON differs in each of the participating centers. For primary analysis, we collect data from subjects with MS-ON, AQP4-IgG+ON and MOG-IgG+ON. For secondary analysis, multimodal data will be collected in subjects with any demyelinating ON (CIS-ON, MS-ON, AQP4-IgG+ON or MOG-IgG+ON and seronegative non-MS-ON). We expect between 30-50% will be ineligible due to the rigorous exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-ever acute ON\n* Onset of visual symptoms within maximum of 30 days\n* Age ≥ 18 years\n* Ability to give written informed consent\n* Presence of written consent\n\nExclusion Criteria:\n\n* MRI contraindication\n* Prior demyelinating diagnosis\n* Diagnosis of other forms of optic neuropathy (hereditary, granulomatous, infectious, infiltrative, toxic)\n* Pregnancy at inclusion\n* Relevant other diseases that conflict with study participation according to protocol\n* Inability to cooperate'}, 'identificationModule': {'nctId': 'NCT05605951', 'acronym': 'ACON', 'briefTitle': 'Acute Optic Neuritis Network: an International Study That Invesitages Subjects With a First-ever Episode of Acute Inflammation of the Optic Nerve', 'organization': {'class': 'OTHER', 'fullName': 'Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul'}, 'officialTitle': 'The Acute Optic Neuritis Network (ACON): a Non-interventional Prospective Multicenter Study on Diagnosis and Treatment of Acute Optic Neuritis', 'orgStudyIdInfo': {'id': 'ACON2022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'non-interventional study', 'type': 'OTHER', 'description': 'observational study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Bennett, Prof.', 'role': 'CONTACT'}, {'name': 'Jeffrey Bennett, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Prem S. Subramanian, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado School of Medicine', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Levy, Prof.', 'role': 'CONTACT'}, {'name': 'Michael Levy, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Itay Lotan, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Harvard Medical School', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Chen, Prof.', 'role': 'CONTACT'}, {'name': 'Sean Pittock, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eoin P. Flanagan, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Departments of Neurology and Ophthalmology, Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Edgar Carnero Contentti, Dr.', 'role': 'CONTACT'}, {'name': 'Dr.', 'role': 'CONTACT'}, {'name': 'Pablo A. Lopez, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Aleman', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Sydney', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Sundarshini Ramanathan, Dr.', 'role': 'CONTACT'}, {'name': 'Sundarshini Ramanathan, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Russel C Dale', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Neurology, Concord Hospital, Faculty of Medicine and Health', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Gaborone', 'status': 'NOT_YET_RECRUITING', 'country': 'Botswana', 'contacts': [{'name': 'Cassandra Ocampo, Dr.', 'role': 'CONTACT'}, {'name': 'Cassandra Ocampo, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jemal Shifa, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Botswana', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}, {'city': 'Minas Gerais', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Marco Lana-Peixoto, Prof.', 'role': 'CONTACT'}, {'name': 'Marco Lana-Peixoto, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Federal University of Minas Gerais, Belo Horizonte', 'geoPoint': {'lat': -8.96667, 'lon': -72.78333}}, {'city': 'Bogotá', 'status': 'NOT_YET_RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Rodrigo Gonzales-Reyes, Dr.', 'role': 'CONTACT'}, {'name': 'Rodrigo Gonzales-Reyes', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ligia Alejandra De La Torre Cifuentes', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Del Rosario University', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Bogotá', 'status': 'NOT_YET_RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Alvaro Jose Mejia Vergara', 'role': 'CONTACT'}], 'facility': 'Department of Ophthalmology, Oftlamo-Sanitas Eye Institute, School of Medicine, Fundación Universitaria Sanitas', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Bogotá', 'status': 'NOT_YET_RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Luis Alfonso Zarco Montero, Dr.', 'role': 'CONTACT'}, {'name': 'Luis Alfonso Zarco Montero, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'José Luis Peralta Uribe, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carolina Garcia-Alfonso, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Pontificia Universidad Javeriana', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Nasrin Asgari, Prof.', 'role': 'CONTACT'}, {'name': 'Nasrin Asgari, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Neurology, Slagelse, Institute for Health Research, University of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Carolin Froment Tilikete, Dr.', 'role': 'CONTACT'}, {'name': 'Carolin Froment Tilikete, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Romain Marignier, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '(MIRCEM) Lyon Civil Hospices, France', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Susanna Asseyer, Dr.', 'role': 'CONTACT'}, {'name': 'Susanna Asseyer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Friedemann Paul, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Philipp Klyscz', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kristina Feldmann', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Experimental and Clinical Research Center, Charité - Universitätsmedizin Berlin, Germany, Department of Neurology', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Munich', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Joachim Havla, Prof.', 'role': 'CONTACT'}, {'name': 'Joachim Havla, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute for Clinical Neuroimmunology, LMU Clinic of Ludwig-Maximilians Universität in Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Mangalore', 'status': 'NOT_YET_RECRUITING', 'country': 'India', 'contacts': [{'name': 'Lekha Pandit, Prof.', 'role': 'CONTACT'}, {'name': 'Lehka Pandit, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nitte University, Karnataka', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'city': 'Jerusalem', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Netta Levin, Prof.', 'role': 'CONTACT'}, {'name': 'Netta Levin, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Adi Vaknine-Dembinsky, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hadassah Hebrew University', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Hadas Stiebel-Kalish, Prof.', 'role': 'CONTACT', 'email': 'kalishhadas@gmail.com'}, {'name': 'Hadas Stiebel-Kalish, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Omer Bialer, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mark Hellmann, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alon Tiosano, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shira Rozenblatt, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adi Wilf-Yarkoni, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sackler School of Medicine and Rabin Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Bologna', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Lugaressi, Prof.', 'role': 'CONTACT'}, {'name': 'Alessandra Lugaressi, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chiara La Morgia, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sara Mariotto, Dr.', 'role': 'CONTACT'}, {'name': 'Sara Mariotto', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sara Carta', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Francesca Bosello', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Fukushima', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kazuo Fujihara, Prof.', 'role': 'CONTACT'}, {'name': 'Kazuo Fujihara, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fukushima Medical University School of Medicine', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ho Jin Kim, Prof.', 'role': 'CONTACT'}, {'name': 'Ho Jin Kim, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cancer Center, Seúl University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Josep Dalmau, Prof.', 'role': 'CONTACT'}, {'name': 'Josep Dalmau, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Albert Saiz, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bernardo Sanchez-Dalmau, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sara Llufriu, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Vidal Angela, Dr.', 'role': 'CONTACT'}, {'name': 'Vidal Angela, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jaume Sastre, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Vall d'Hebron Barcelona Hospital Campus", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Birmingham', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Susan Mollan, Dr.', 'role': 'CONTACT'}, {'name': 'Susan Mollan, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fiona Chan, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospitals of Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Oxford', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Jacqueline Palace, Prof.', 'role': 'CONTACT'}, {'name': 'Jacqueline Palace, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Maria Isabel Leite, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'Lusaka', 'status': 'NOT_YET_RECRUITING', 'country': 'Zambia', 'contacts': [{'name': 'Deanna Saylor, Dr.', 'role': 'CONTACT'}, {'name': 'Deanna Saylor, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mashina Chomba, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Teaching Hospital in Lusaka', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'centralContacts': [{'name': 'Susanna Asseyer, Dr. med.', 'role': 'CONTACT', 'email': 'susanna.asseyer@charite.de', 'phone': '030450639727'}, {'name': 'Hadas Stiebel-Kalish, Prof.', 'role': 'CONTACT', 'email': 'kalishhadas@gmail.com'}], 'overallOfficials': [{'name': 'Susanna Asseyer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}, {'name': 'Hadas Stiebel-Kalish', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center, Tel Aviv'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The datasets generated and/or analyzed during the current study are not publicly available but are available from the corresponding author upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}