Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT04458051
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2020-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Singapore', 'Switzerland', 'United Arab Emirates']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 767}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2020-07-01', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-month composite Confirmed Disability Progression (cCDP)', 'timeFrame': 'Up to approximately 60 months', 'description': 'Time to onset of 6-month cCDP defined as follows:\n\nIncrease over at least 6 months of ≥1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is ≤5.5, or ≥0.5 points when the baseline EDSS score is \\>5.5, or ≥20% from the baseline T25-FW, or ≥20% from the baseline 9-HPT'}], 'secondaryOutcomes': [{'measure': '6-month Confirmed Disability Progression (CDP)', 'timeFrame': 'Up to approximately 60 months', 'description': 'Time to onset of 6-month CDP as assessed by EDSS score'}, {'measure': '3-month composite Confirmed Disability Progression (cCDP)', 'timeFrame': 'Up to approximately 60 months', 'description': 'Time to onset of 3-month cCDP'}, {'measure': 'Change in T2 hyperintense lesions by MRI', 'timeFrame': 'From screening MRI to approximately 60 months', 'description': 'Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI after baseline up to and including the end of study (EOS)'}, {'measure': 'Time to onset of confirmed disability improvement (CDI)', 'timeFrame': 'Up to approximately 60 months', 'description': 'Time to onset of CDI defined as ≥1.0-point decrease on the EDSS score from baseline confirmed over at least 6 months'}, {'measure': 'Percent change in Brain volume (BV)', 'timeFrame': 'From 6 months up to approximately 60 months', 'description': 'Percent change in brain volume (BV) as detected by brain MRI at the EOS compared to month 6'}, {'measure': 'Change in cognitive function as assessed by SDMT', 'timeFrame': 'From Baseline up to approximately 60 months', 'description': 'Change in cognitive function at the EOS compared to baseline as assessed by the Symbol Digit Modalities Test (SDMT)'}, {'measure': 'Change in cognitive function as assessed by CVLT-II', 'timeFrame': 'From Baseline up to approximately 60 months', 'description': 'Change in cognitive function at the EOS compared to baseline as assessed by the California Verbal Learning Test II (CVLT-II) where available'}, {'measure': 'Change in Multiple Sclerosis Quality of Life', 'timeFrame': 'From Baseline up to approximately 60 months', 'description': 'Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) at the EOS compared to baseline'}, {'measure': 'Safety and Tolerability', 'timeFrame': 'From screening up to approximately 60 months', 'description': 'Number of participants with adverse events (AEs), Serious AEs, AEs leading to permanent study intervention discontinuation, and adverse events of special interest (AESI)'}, {'measure': 'Population pharmacokinetics', 'timeFrame': 'Months 6, 9 and 12', 'description': 'Plasma concentration of SAR442168 (population PK assessment) at Months 6, 9, and 12'}, {'measure': 'Change in plasma neurofilament light chain (NfL)', 'timeFrame': 'From Baseline up to approximately 60 months', 'description': 'Change in NfL levels from at the EOS compared to baseline'}, {'measure': 'Change in lymphocyte phenotype subsets', 'timeFrame': 'From Baseline up to approximately 60 months', 'description': 'Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline in a subset of participants'}, {'measure': 'Changes in serum Immunoglobulin level', 'timeFrame': 'From Baseline up to approximately 60 months', 'description': 'Changes in serum Immunoglobulin level at the EOS compared to baseline'}, {'measure': 'Change in serum chitinase-3 like protein 1 (Chi3L1)', 'timeFrame': 'From Baseline up to approximately 60 months', 'description': 'Change in serum Chi3L1 at EOS compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Progressive Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS)\n\nSecondary Objectives:\n\nTo evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168', 'detailedDescription': 'Study duration will vary per participant in this event driven trial with a treatment duration of approximately 12 to 60 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 to 55 years of age inclusive\n* Diagnosis of PPMS according to the 2017 McDonald criteria\n* Expanded disability status scale (EDSS) score between 2.0 to 6.5 points, at screening inclusive\n* Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG) index either during screening or documented previous history.\n* Contraceptive use consistent with local regulations for individuals participating in clinical studies\n* Participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n* Is not a woman of childbearing potential (WOCBP) or is a WOCBP and agrees to use an acceptable contraceptive method\n* the participant must not have access to ocrelizumab (eg, ocrelizumab not available on the national market or not reimbursed for the approved indication).\n* the participant must have access to and be eligible to be treated with ocrelizumab but: 1) does not tolerate it due to side effects or safety reasons; and/or 2) has failed ocrelizumab treatment due to perceived lack of efficacy\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Participant has conditions that would adversely affect study participation such as short life expectancy.\n* Evidence of infection with human immunodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection that would adversely affect study participation.\n* Persistent chronic or active or recurring system infection that may adversely affect participation or IMP administration in this study as judged by the investigator\n* History of malignancy within 5 years prior to screening.\n* History of alcohol or drug abuse within 1 year prior to Screening.\n* Hospitalized for psychiatric disease within 2 years prior to Screening.\n* Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.\n* A bleeding disorder or known platelet dysfunction at any time prior to the screening visit.\n* A platelet count \\<150 000/μL at the screening visit.\n* A history of significant bleeding event within 6 months prior to screening, according to the Investigator's judgment such as, but not limited to cerebral or gastrointestinal\n* Lymphocyte count below the lower limit of normal at Screening.\n* Recent live (attenuated) vaccine within 2 months before the first treatment visit.\n* Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study.\n* The participant has received medications/treatments for MS within a specified time frame.\n* Receiving potent and moderate inducers of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes.\n* Receiving anticoagulant or antiplatelet therapy (such as aspirin \\>81mg/day, clopidogrel, warfarin).\n* Contraindications to magnetic resonance imaging (MRI).\n\nNOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial"}, 'identificationModule': {'nctId': 'NCT04458051', 'acronym': 'PERSEUS', 'briefTitle': "Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)', 'orgStudyIdInfo': {'id': 'EFC16035'}, 'secondaryIdInfos': [{'id': 'U1111-1238-1318', 'type': 'REGISTRY', 'domain': 'ICTRP'}, {'id': '2024-514495-41', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': '2020-000645-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAR442168', 'description': 'Dose 1 of oral SAR442168 once daily', 'interventionNames': ['Drug: Tolebrutinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo to match the SAR442168 once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tolebrutinib', 'type': 'DRUG', 'otherNames': ['SAR442168'], 'description': 'Pharmaceutical form: Film-coated Tablet Route of administration: Oral', 'armGroupLabels': ['SAR442168']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: Film-coated Tablet Route of administration: Oral', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego ACTRI Site Number : 8400101', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Research Site Number : 8400045', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Multiple Sclerosis Center- Site Number : 8400143', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Multiple Sclerosis Center of California Site Number : 8400135', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'SC3 Research - Pasadena Site Number : 8400070', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of San Francisco, Sandler Neurosciences Center- Site Number : 8400137', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor UCLA Site Number : 8400088', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '90048', 'city': 'West Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Regina Berkovich, MD, PhD Site Number : 8400059', 'geoPoint': {'lat': 34.09001, 'lon': -118.36174}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Advanced Neurosciences Research Site Number : 8400025', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '33487', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Neurology Associates Site Number : 8400029', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'MS & Neuromuscular Center of Excellence Site Number : 8400172', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32601', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida, Fixel Center for Neurology Site Number : 8400159', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32761', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurology Associates, PA- Site Number : 8400004', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida Site Number : 8400006', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Velocity Clinical Research Site Number : 8400003', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Pacific Neuroscience Site Number : 8400103', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60062', 'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Consultants In Neurology- Site Number : 8400011', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'zip': '46410', 'city': 'Merrillville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Methodist Hospital Site Number : 8400164', 'geoPoint': {'lat': 41.48281, 'lon': -87.33281}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'College Park Family Care Center Site Number : 8400044', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Site Number : 8400106', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Baptist Clinical Trials Unit (CTU)- Site Number : 8400107', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21093', 'city': 'Lutherville', 'state': 'Maryland', 'country': 'United States', 'facility': 'International Neurorehabilitation Institute Site Number : 8400034', 'geoPoint': {'lat': 39.42122, 'lon': -76.62608}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center Site Number : 8400072', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Site Number : 8400014', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Institute For Neurological Disorders Site Number : 8400058', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '48867', 'city': 'Owosso', 'state': 'Michigan', 'country': 'United States', 'facility': 'The Memorial Hospital- Site Number : 8400033', 'geoPoint': {'lat': 42.9978, 'lon': -84.17664}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Site Number : 8400111', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '65721', 'city': 'Ozark', 'state': 'Missouri', 'country': 'United States', 'facility': 'Sharlin Health & Neurology Site Number : 8400093', 'geoPoint': {'lat': 37.02089, 'lon': -93.20602}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University Of Nebraska- Site Number : 8400129', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Hospital Site Number : 8400047', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Site Number : 8400032', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10029-6501', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai (Department of Endoc Site Number : 8400038', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Neurology Associates of Stony Brook Site Number : 8400042', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Neurological Disorders Clinic- Site Number : 8400098', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Meridian Clinical Research, LLC- Site Number : 8400005', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atrium Health Wake Forest Baptist Site Number : 8400116', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Riverhills Neuroscience - Norwood Site Number : 8400167', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Site Number : 8400125', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center- Site Number : 8400150', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43235', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Boster Center for Multiple Sclerosis Site Number : 8400147', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Multiple Sclerosis Center Site Number : 8400020', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Neurology Associates Site Number : 8400016', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29651-1817', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Mountain View Clinical Research Site Number : 8400024', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '77450', 'city': 'Katy', 'state': 'Texas', 'country': 'United States', 'facility': 'Mt Olympus Medical Research Site Number : 8400163', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Neurology Center of San Antonio Site Number : 8400036', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'C1012AAR', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320002'}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320003', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '2139', 'city': 'Concord', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360005', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360006', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '7001', 'city': 'Hobart', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360003', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '4021', 'city': 'Linz', 'country': 'Austria', 'facility': 'Investigational Site Number : 0400004', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Investigational Site Number : 0400002', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '210009', 'city': 'Vitebsk', 'country': 'Belarus', 'facility': 'Investigational Site Number : 1120004', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}, {'zip': '210037', 'city': 'Vitebsk', 'country': 'Belarus', 'facility': 'Investigational Site Number : 1120005', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Investigational Site Number : 0560009', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Investigational Site Number : 0560004', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Investigational Site Number : 0560008', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '3900', 'city': 'Overpelt', 'country': 'Belgium', 'facility': 'Investigational Site Number : 0560001', 'geoPoint': {'lat': 51.21038, 'lon': 5.41557}}, {'zip': '1200', 'city': 'Woluwe-Saint-Lambert', 'country': 'Belgium', 'facility': 'Investigational Site Number : 0560007', 'geoPoint': {'lat': 50.84389, 'lon': 4.42912}}, {'zip': '81210-310', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Instituto de Neurologia de Curitiba Site Number : 0760002', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '01228-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'CPQuali Pesquisa Clinica Site Number : 0760007', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '5809', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Investigational Site Number : 1000002', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '1113', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Investigational Site Number : 1000004', 'geoPoint': {'lat': 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