Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-24 @ 10:56 AM
Study NCT ID:
NCT02337751
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2015-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 52 weeks', 'description': 'At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + TVP-1012 Group', 'description': 'Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 23, 'seriousNumAtRisk': 95, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'TVP-1012 + TVP-1012 Group', 'description': 'TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 49, 'seriousNumAtRisk': 117, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukoplakia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mechanical ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Microscopic polyangiitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TVP-1012 Group', 'description': 'Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.'}, {'id': 'OG001', 'title': 'TVP-1012 + TVP-1012 Group', 'description': 'TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 52 weeks', 'description': 'Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study and/or the preceding study (TVP-1012/CCT-001: NCT02337725). The analysis set included 103 participants who enrolled in this study and 14 participants who enrolled only in TVP-1012/CCT-001 and received TVP-1012 (totally 117 participants).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAE Related to Clinical Laboratory Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TVP-1012 Group', 'description': 'Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.'}, {'id': 'OG001', 'title': 'TVP-1012 + TVP-1012 Group', 'description': 'TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.'}], 'classes': [{'title': 'Blood Creatine Phosphokinase Increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blood Triglycerides Increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urine Present', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'C-Reactive Protein Increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Glycosylated Haemoglobin Increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Liver Function Test Abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Liver Function Test Increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cell Count Increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 52 weeks', 'description': 'Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study and/or the preceding study (TVP-1012/CCT-001: NCT02337725). The analysis set included 103 participants who enrolled in this study and 14 participants who enrolled only in TVP-1012/CCT-001 and received TVP-1012 (totally 117 participants).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Markedly Abnormal Vital Signs Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TVP-1012 Group', 'description': 'Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.'}, {'id': 'OG001', 'title': 'TVP-1012 + TVP-1012 Group', 'description': 'TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.'}], 'classes': [{'title': 'Temperature <35.6 Celsius (ºC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Temperature >37.7 ºC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Systolic Blood Pressure <90 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure <50 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure >100 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Pulse <45 Beats per Minute (bpm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 52 weeks', 'description': 'Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Here "mmHg" is Millimeter of mercury. Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants.\n\nThe number of participants analyzed for each items are participants evaluable for each item within the safety analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TVP-1012 Group', 'description': 'Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.'}, {'id': 'OG001', 'title': 'TVP-1012 + TVP-1012 Group', 'description': 'TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 52 weeks', 'description': 'Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study and/or the preceding study (TVP-1012/CCT-001: NCT02337725). The analysis set included 103 participants who enrolled in this study and 14 participants who enrolled only in TVP-1012/CCT-001 and received TVP-1012 (totally 117 participants).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAE Related to Body Weight (Weight Loss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TVP-1012 Group', 'description': 'Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.'}, {'id': 'OG001', 'title': 'TVP-1012 + TVP-1012 Group', 'description': 'TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 52 weeks', 'description': 'Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study and/or the preceding study (TVP-1012/CCT-001: NCT02337725). The analysis set included 103 participants who enrolled in this study and 14 participants who enrolled only in TVP-1012/CCT-001 and received TVP-1012 (totally 117 participants).'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TVP-1012 Group', 'description': 'Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.'}, {'id': 'OG001', 'title': 'TVP-1012 +TVP-1012 Group', 'description': 'TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.8', 'spread': '6.01', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '9.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to End of treatment (Week 52)', 'description': 'MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II+III Total Score was 0-188, with the higher score reflecting the greater severity. Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS); All randomized participants who received at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants. The analyzed numbers for each arm were participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + TVP-1012 Group', 'description': 'TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks. Reported data on Participants Flow was all participants who enrolled in this study and had assigned to Placebo group in preceding study.'}, {'id': 'FG001', 'title': 'TVP-1012 + TVP-1012 Group', 'description': 'TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks. Reported data on Participants Flow was all participants who enrolled in this study and had assigned to TVP-1012 group in preceding study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Pretreatment Event/Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': "Investigator's Judgement", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 68 investigative sites in Japan, from 10 July 2015 to 14 March 2017.', 'preAssignmentDetails': "All participants with Parkinson's disease who completed the 26-week treatment period in preceding study (TVP-1012/CCT-001: NCT02337725) were enrolled in this study. Participants in TVP-1012 group and in Placebo group in preceding study were assigned to TVP-1012+TVP-1012 Group and Placebo+TVP-1012 Group in this study, respectively."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + TVP-1012 Group', 'description': 'Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for 26 weeks.'}, {'id': 'BG001', 'title': 'TVP-1012 + TVP-1012 Group', 'description': 'TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for 26 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65.4', 'spread': '9.13', 'groupId': 'BG000'}, {'value': '67.4', 'spread': '8.99', 'groupId': 'BG001'}, {'value': '66.5', 'spread': '9.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'All participants were enrolled in Japan.', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '159.2', 'spread': '9.28', 'groupId': 'BG000'}, {'value': '158.9', 'spread': '8.87', 'groupId': 'BG001'}, {'value': '159.0', 'spread': '9.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56.68', 'spread': '9.773', 'groupId': 'BG000'}, {'value': '57.91', 'spread': '11.803', 'groupId': 'BG001'}, {'value': '57.36', 'spread': '10.932', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22.28', 'spread': '2.798', 'groupId': 'BG000'}, {'value': '22.78', 'spread': '3.303', 'groupId': 'BG001'}, {'value': '22.56', 'spread': '3.090', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index = weight (kg)/\\[height (m)\\^2\\]', 'unitOfMeasure': 'kg/meter (m)^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Never Smoked', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Current Smoker', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Ex-Smoker', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Timing of Study Drug Dose', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Before Breakfast', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'After Breakfast', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Duration of Parkinson's Disease", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.52', 'spread': '1.223', 'groupId': 'BG000'}, {'value': '1.97', 'spread': '1.981', 'groupId': 'BG001'}, {'value': '1.77', 'spread': '1.695', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Modified Hoehn & Yahr Stage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.13', 'spread': '0.627', 'groupId': 'BG000'}, {'value': '2.18', 'spread': '0.628', 'groupId': 'BG001'}, {'value': '2.16', 'spread': '0.627', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Modified Hoehn \\& Yahr Stage represented severity for symptoms of Parkinson's disease progress. The Stage of Modified Hoehn \\& Yahr were assigned from Stage 0 (Asymptomatic) to Stage 5 (Wheelchair bound or bedridden unless aided (unable to walk even if aided)).", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'MDS-UPDRS Part II + Part III Total Score (Pre-Dose)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.0', 'spread': '15.86', 'groupId': 'BG000'}, {'value': '34.4', 'spread': '16.95', 'groupId': 'BG001'}, {'value': '33.8', 'spread': '16.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retained the four-scale structure with a reorganization of the various subscales: (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (6 items). Each subscale had 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II+III Total Score was 0-188, with the higher score reflecting the greater severity.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety Analysis Set; All participants who received at least one dose of TVP-1012 during this study and/or the preceding study (TVP-1012/CCT-001: NCT02337725). The analysis set included 103 participants who enrolled in this study and 14 participants who enrolled only in TVP-1012/CCT-001 and received TVP-1012 (totally 117 participants).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-24', 'size': 1900596, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-02-25T21:31', 'hasProtocol': True}, {'date': '2017-04-11', 'size': 923234, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-02-25T21:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-17', 'studyFirstSubmitDate': '2015-01-09', 'resultsFirstSubmitDate': '2018-02-25', 'studyFirstSubmitQcDate': '2015-01-09', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-23', 'studyFirstPostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)', 'timeFrame': 'Up to 52 weeks', 'description': 'Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With TEAE Related to Clinical Laboratory Tests', 'timeFrame': 'Up to 52 weeks', 'description': 'Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).'}, {'measure': 'Number of Participants With Markedly Abnormal Vital Signs Values', 'timeFrame': 'Up to 52 weeks', 'description': 'Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Here "mmHg" is Millimeter of mercury. Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).'}, {'measure': 'Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)', 'timeFrame': 'Up to 52 weeks', 'description': 'Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).'}, {'measure': 'Number of Participants With TEAE Related to Body Weight (Weight Loss)', 'timeFrame': 'Up to 52 weeks', 'description': 'Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).'}, {'measure': "Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score", 'timeFrame': 'Baseline to End of treatment (Week 52)', 'description': 'MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II+III Total Score was 0-188, with the higher score reflecting the greater severity. Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '30689042', 'type': 'DERIVED', 'citation': "Hattori N, Takeda A, Takeda S, Nishimura A, Kitagawa T, Mochizuki H, Nagai M, Takahashi R. Long-term, open-label, phase 3 study of rasagiline in Japanese patients with early Parkinson's disease. J Neural Transm (Vienna). 2019 Mar;126(3):299-308. doi: 10.1007/s00702-018-1964-3. Epub 2019 Jan 28."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the long-term safety of TVP-1012 (1 mg/day) in Japanese participants with early Parkinson's disease.", 'detailedDescription': "This is a multicenter, open-label, long-term, extension, phase 3 study to evaluate the safety and efficacy of long-term administration of TVP-1012 at 1 mg for another 26 weeks in participants with early Parkinson's disease who have completed the preceding TVP-1012/CCT-001 (NCT02337725) study.\n\nAmong participants of the TVP-1012/CCT-001 study, those consenting to participate in this study prior to complete the preceding study and fulfilling the eligibility criteria will be enrolled in this study. From the day after the Visit 8 of the preceding study, participants will receive 1 mg of TVP-1012 once daily for 26 weeks in an unblinded manner."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant has completed the preceding study.\n* The participant has shown no safety issues during the study treatment in the preceding study, in the opinion of the investigator or subinvestigator.\n\nExclusion Criteria:\n\n* The participant has undergone blood collection of \\>= 400 mL within 90 days prior to the start of treatment in this study.\n* The participant is required to take any of the excluded medications or treatments.\n* The participant is required surgery or hospitalization for surgery during the study period.'}, 'identificationModule': {'nctId': 'NCT02337751', 'briefTitle': "A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants", 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': "A Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa", 'orgStudyIdInfo': {'id': 'TVP-1012/OCT-001'}, 'secondaryIdInfos': [{'id': 'U1111-1165-1437', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': 'JapicCTI-152761', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TVP-1012 1mg Group', 'description': 'TVP-1012 (1 mg/day) once daily, either before or after breakfast.', 'interventionNames': ['Drug: TVP-1012 1mg']}], 'interventions': [{'name': 'TVP-1012 1mg', 'type': 'DRUG', 'description': 'TVP-1012 1mg Tablets', 'armGroupLabels': ['TVP-1012 1mg Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Tōon', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.79427, 'lon': 132.89011}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Ōnojō', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.53567, 'lon': 130.47861}}, {'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'city': 'Iwamizawa', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.20028, 'lon': 141.75972}}, {'city': 'Akashi', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.65524, 'lon': 135.00687}}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Tsuchiura', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.09047, 'lon': 140.21047}}, {'city': 'Tsukuba', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'city': 'Ichinoseki', 'state': 'Iwate', 'country': 'Japan', 'geoPoint': {'lat': 38.91667, 'lon': 141.13333}}, {'city': 'Morioka', 'state': 'Iwate', 'country': 'Japan', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'city': 'Takamatsu', 'state': 'Kagawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'city': 'Fujisawa', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.34926, 'lon': 139.47666}}, {'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Gōshi', 'state': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.75601, 'lon': 130.67928}}, {'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Matsumoto', 'state': 'Nagano', 'country': 'Japan', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Nishisonogi', 'state': 'Nagasaki', 'country': 'Japan'}, {'city': 'Sonogishukugō', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 33.03689, 'lon': 129.91964}}, {'city': 'Tenri', 'state': 'Nara', 'country': 'Japan', 'geoPoint': {'lat': 34.58333, 'lon': 135.83333}}, {'city': 'Jōetsu', 'state': 'Niigata', 'country': 'Japan', 'geoPoint': {'lat': 37.14828, 'lon': 138.23642}}, {'city': 'Higashiosaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.66667, 'lon': 135.58333}}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Takatsuki', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'city': 'Toyonaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.78244, 'lon': 135.46932}}, {'city': 'Irima', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Fuji', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 35.16667, 'lon': 138.68333}}, {'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'city': 'Izunokuni', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 35.03907, 'lon': 138.95143}}, {'city': 'Shimono', 'state': 'Tochigi', 'country': 'Japan'}, {'city': 'Yoshinogawa', 'state': 'Tokushima', 'country': 'Japan', 'geoPoint': {'lat': 34.03858, 'lon': 134.29207}}, {'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Fuchū', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.67452, 'lon': 139.48216}}, {'city': 'Kodaira', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.72603, 'lon': 139.48508}}, {'city': 'Meguro-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Nerima-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Ōta-ku', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.56126, 'lon': 139.71605}}, {'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Shibuya-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Akita', 'country': 'Japan', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Aomori', 'country': 'Japan', 'geoPoint': {'lat': 40.81667, 'lon': 140.73333}}, {'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukushima', 'country': 'Japan', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'city': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Kochi', 'country': 'Japan', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Niigata', 'country': 'Japan', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Okayama', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Tokushima', 'country': 'Japan', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'city': 'Toyama', 'country': 'Japan', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'city': 'Wakayama', 'country': 'Japan', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}, {'city': 'Yamagata', 'country': 'Japan', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}