Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-04-18 @ 10:48 PM
Study NCT ID:
NCT02335658
Status:
COMPLETED
Last Update Posted:
2022-04-12
First Post:
2015-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Study of DSP-5423P in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cc@ds-pharma.co.jp', 'phone': '+81-3-5159-2519', 'title': 'Clinical Research', 'organization': 'Sumitomo Dainippon Pharmaceutical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for 52 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'DSP-5423P (Cohort 1)', 'description': 'Percutaneous\n\nDSP-5423P: 40-80mg/day', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 82, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'DSP-5423P (Cohort 2)', 'description': 'Percutaneous\n\nDSP-5423P: 40-80mg/day', 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 92, 'seriousNumAtRisk': 103, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'DSP-5423P (Overall)', 'description': 'Percutaneous\n\nDSP-5423P: 40-80mg/day\n\nCohort 1 + Cohort 2', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 174, 'seriousNumAtRisk': 200, 'deathsNumAffected': 0, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Hyperprolactinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Application site dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 17, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 38, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 61, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 42, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 46, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 88, 'numAffected': 62}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood prolactin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia haemophilus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Impulse-control disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Events and Adverse Drug Reactions, Etc.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DSP-5423P (Cohort 1)', 'description': 'Percutaneous\n\nDSP-5423P: 40-80mg/day'}, {'id': 'OG001', 'title': 'DSP-5423P (Cohort 2)', 'description': 'Percutaneous\n\nDSP-5423P: 40-80mg/day'}, {'id': 'OG002', 'title': 'DSP-5423P (Overall)', 'description': 'Percutaneous\n\nDSP-5423P: 40-80mg/day'}], 'classes': [{'title': 'Subjects with any AE', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with any treatment-related ADR', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 52', 'description': 'Number of Subjects With Adverse Event (AE) and Adverse Drug Reaction (ADR) An adverse event (AE) is any untoward medical occurrence in a study subject administered a medicinal (investigational) product and which does not necessarily have a causal relationship with this treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.\n\nAn adverse drug reaction (ADR) is any AE which has a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population-received at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week52 and Week 52 Last Observation Carried Forward(LOCF) From DSP-5423P Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DSP-5423P (Cohort 1)', 'description': 'Percutaneous\n\nDSP-5423P: 40-80mg/day'}, {'id': 'OG001', 'title': 'DSP-5423P (Cohort 2)', 'description': 'Percutaneous\n\nDSP-5423P: 40-80mg/day'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '63.6', 'spread': '21.23', 'groupId': 'OG000'}, {'value': '67.5', 'spread': '21.34', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 52', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '8.41', 'groupId': 'OG000'}, {'value': '-9.2', 'spread': '15.08', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 52 (LOCF)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '11.59', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '15.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 52, Week 52 (LOCF)', 'description': 'The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and 3 subscales: the Positive subscale assesses hallucinations, delusions, and related symptoms; the Negative subscale assesses emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.\n\nThe LOCF endpoint is defined as the last data captured on Day 1 through 7 days after the final application of DSP-5423P.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population-received at least one dose of study medication'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DSP-5423P (Cohort 1)', 'description': 'Percutaneous DSP-5423P: 40-80mg/day, once daily The initial dose of DSP-5423P in Cohort 1 was corresponding to the final dose of DSP-5423 (tablet) in previous period.'}, {'id': 'FG001', 'title': 'DSP-5423P (Cohort 2)', 'description': 'Percutaneous DSP-5423P: 40-80mg/day, once daily The initial dose of DSP-5423P in Cohort 2 was 40 mg/day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '97 subjects in Cohort 1 and 103 subjects in Cohort 2 started to receive DSP-5423P.', 'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '57 subjects in Cohort 1 and 59 subjects in Cohort 2 completed the study.', 'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DSP-5423P (Cohort 1)', 'description': 'Percutaneous\n\nDSP-5423P: 40-80mg/day'}, {'id': 'BG001', 'title': 'DSP-5423P (Cohort 2)', 'description': 'Percutaneous\n\nDSP-5423P: 40-80mg/day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'spread': '14.43', 'groupId': 'BG000'}, {'value': '43.6', 'spread': '12.63', 'groupId': 'BG001'}, {'value': '43.8', 'spread': '13.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety population-received at least one dose of study medication'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-30', 'size': 1685438, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-08-31T19:50', 'hasProtocol': True}, {'date': '2017-06-08', 'size': 2669050, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-08-31T19:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-09', 'studyFirstSubmitDate': '2015-01-07', 'resultsFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2015-01-07', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-28', 'studyFirstPostDateStruct': {'date': '2015-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events and Adverse Drug Reactions, Etc.', 'timeFrame': 'week 52', 'description': 'Number of Subjects With Adverse Event (AE) and Adverse Drug Reaction (ADR) An adverse event (AE) is any untoward medical occurrence in a study subject administered a medicinal (investigational) product and which does not necessarily have a causal relationship with this treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.\n\nAn adverse drug reaction (ADR) is any AE which has a causal relationship with this treatment.'}], 'secondaryOutcomes': [{'measure': 'Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week52 and Week 52 Last Observation Carried Forward(LOCF) From DSP-5423P Baseline', 'timeFrame': 'Week 52, Week 52 (LOCF)', 'description': 'The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and 3 subscales: the Positive subscale assesses hallucinations, delusions, and related symptoms; the Negative subscale assesses emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.\n\nThe LOCF endpoint is defined as the last data captured on Day 1 through 7 days after the final application of DSP-5423P.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '31883082', 'type': 'DERIVED', 'citation': 'Iwata N, Ishigooka J, Naoi I, Matsumoto M, Kanamori Y, Nakamura H, Higuchi T. Long-Term Safety and Efficacy of Blonanserin Transdermal Patches in Japanese Patients with Schizophrenia: A 52-Week Open-Label, Multicenter Study. CNS Drugs. 2020 Jan;34(1):103-116. doi: 10.1007/s40263-019-00692-6.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have schizophrenia diagnosed by DSM-5, diagnostic criteria\n* Patients who are aged 18 years or older at informed consent\n* Patient understands the objectives and procedures of the study and who provide written voluntarily consent to participate in the study, etc.\n\nExclusion Criteria:\n\n* Patients who fall under a contraindication listed in the LONASEN® package insert\n* Patients with Parkinson disease, etc.'}, 'identificationModule': {'nctId': 'NCT02335658', 'briefTitle': 'Long-term Study of DSP-5423P in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma Co., Ltd.'}, 'officialTitle': 'Long-term Study of DSP-5423P in Patients With Schizophrenia <Phase 3>', 'orgStudyIdInfo': {'id': 'D4904040'}, 'secondaryIdInfos': [{'id': 'JapicCTI-152765', 'type': 'REGISTRY', 'domain': 'JAPIC Clinical Trials Informaton'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DSP-5423P', 'description': 'Percutaneous', 'interventionNames': ['Drug: DSP-5423P']}], 'interventions': [{'name': 'DSP-5423P', 'type': 'DRUG', 'description': '40-80mg/day', 'armGroupLabels': ['DSP-5423P']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': '38 Sites', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Director, Drug Development Division', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sumitomo Pharma Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sumitomo Pharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}