Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT05628103
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2022-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000705647', 'term': 'SEP-363856'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smb_clinicaltranspa@otsuka-us.com', 'phone': '1-800-441-6763', 'title': 'Clinical Transparency', 'organization': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to end of follow up period (up to Week 9)', 'description': 'Safety population included all participants that were enrolled and received the study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'SEP-363856', 'description': 'Participants received flexible doses of SEP-363856 50 to 100 mg/day, orally, QD up to Week 8. The dose was titrated up from 50 mg/day on Days 1 to 3, to 75 mg/day on Days 4 to 7. Beginning Day 8, the dose was adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50, 75, or 100 mg/day) up to Week 8.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 13, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SEP-363856', 'description': 'Participants received flexible doses of SEP-363856 50 to 100 mg/day, orally, QD up to Week 8. The dose was titrated up from 50 mg/day on Days 1 to 3, to 75 mg/day on Days 4 to 7. Beginning Day 8, the dose was adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50, 75, or 100 mg/day) up to Week 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '13.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of the study drug up to end of follow up (up to Week 9)', 'description': 'Discontinuation for clinical reasons was defined as reasons due to adverse event (AE) or lack of efficacy. AEs are defined as untoward medical occurrences that started at the same time of or after the first dose of study drug. The percentage of participants who discontinued for clinical reasons was calculated by a proportion consisting of the number of participants who experience a discontinuation event due to clinical reasons as the numerator divided by the number of participants in the safety population as the denominator multiplied by 100 along with a corresponding 95% confidence interval (CI). 95% CI was calculated using the normal approximation method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants that were enrolled and received the study drug. Percentages are rounded off to the nearest decimal point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Discontinued From the Study Due to Any Reason', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SEP-363856', 'description': 'Participants received flexible doses of SEP-363856 50 to 100 mg/day, orally, QD up to Week 8. The dose was titrated up from 50 mg/day on Days 1 to 3, to 75 mg/day on Days 4 to 7. Beginning Day 8, the dose was adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50, 75, or 100 mg/day) up to Week 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '25.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of the study drug up to end of follow-up period (up to Week 9)', 'description': 'The percentage of participants who discontinued from the study due to any reason was calculated by a proportion consisting of the number of participants who experience a discontinuation event due to any reason as the numerator divided by the number of participants in the safety population as the denominator multiplied by 100 along with a corresponding 95% CI. 95% CI was calculated using the normal approximation method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants that were enrolled and received the study drug. Percentages are rounded off to the nearest decimal point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SEP-363856', 'description': 'Participants received flexible doses of SEP-363856 50 to 100 milligrams per day (mg/day), orally, once daily (QD) up to Week 8. The dose was titrated up from 50 mg/day on Days 1 to 3, to 75 mg/day on Days 4 to 7. Beginning Day 8, the dose was adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50, 75, or 100 mg/day) up to Week 8.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Non-Compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 26 clinical sites in the United States (US) from 19 December 2022 to 01 April 2024.', 'preAssignmentDetails': 'A total of 243 participants were screened, of which 101 participants entered the study, and all 101 participants received at least one dose of SEP-363856 in the 8-week treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SEP-363856', 'description': 'Participants received flexible doses of SEP-363856 50 to 100 mg/day, orally, QD up to Week 8. The dose was titrated up from 50 mg/day on Days 1 to 3, to 75 mg/day on Days 4 to 7. Beginning Day 8, the dose was adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50, 75, or 100 mg/day) up to Week 8.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'spread': '12.02', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '83', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants that were enrolled and received the study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-06', 'size': 1328567, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-29T13:51', 'hasProtocol': True}, {'date': '2024-05-06', 'size': 27145768, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-29T13:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'dispFirstSubmitDate': '2025-03-28', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2022-11-16', 'resultsFirstSubmitDate': '2025-10-30', 'studyFirstSubmitQcDate': '2022-11-16', 'dispFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-30', 'studyFirstPostDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons', 'timeFrame': 'From the first dose of the study drug up to end of follow up (up to Week 9)', 'description': 'Discontinuation for clinical reasons was defined as reasons due to adverse event (AE) or lack of efficacy. AEs are defined as untoward medical occurrences that started at the same time of or after the first dose of study drug. The percentage of participants who discontinued for clinical reasons was calculated by a proportion consisting of the number of participants who experience a discontinuation event due to clinical reasons as the numerator divided by the number of participants in the safety population as the denominator multiplied by 100 along with a corresponding 95% confidence interval (CI). 95% CI was calculated using the normal approximation method.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Discontinued From the Study Due to Any Reason', 'timeFrame': 'From first dose of the study drug up to end of follow-up period (up to Week 9)', 'description': 'The percentage of participants who discontinued from the study due to any reason was calculated by a proportion consisting of the number of participants who experience a discontinuation event due to any reason as the numerator divided by the number of participants in the safety population as the denominator multiplied by 100 along with a corresponding 95% CI. 95% CI was calculated using the normal approximation method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'This study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.', 'detailedDescription': 'This was an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study.\n\nFollowing a screening period of up to 21 days, eligible participants took part in the study. In the 8-week treatment period, participants were treated with SEP-363856 while continuing to take the full dose of their pre-switch antipsychotic. After the end of the treatment period, participants were required to complete the follow-up visit, 7 days after the last dose of SEP-363856.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: This list is not all inclusive\n\n* Participants meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a diagnosis of schizophrenia.\n* Participants are judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline.\n* Participants must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy.\n* Participants are taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening.\n\nExclusion Criteria:This list is not all inclusive\n\n* Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment.\n* Participants are at significant risk of harming self or others based on investigator's judgment.\n* Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study.\n* Female participant who is pregnant or lactating.\n* Participant tests positive for drugs of abuse at Screening."}, 'identificationModule': {'nctId': 'NCT05628103', 'briefTitle': 'A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'An 8-Week, Open-Label Study Evaluating the Effectiveness, Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents', 'orgStudyIdInfo': {'id': 'SEP361-308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SEP-363856', 'description': 'Participants received flexible doses of SEP-363856 50 to 100 milligrams per day (mg/day), orally, once daily (QD) up to Week 8. The dose was titrated up from 50 mg/day on Days 1 to 3, to 75 mg/day on Days 4 to 7. Beginning Day 8, the dose was adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50, 75, or 100 mg/day) up to Week 8.', 'interventionNames': ['Drug: SEP-363856']}], 'interventions': [{'name': 'SEP-363856', 'type': 'DRUG', 'description': 'SEP-363856 flexibly dosed for 8 weeks.', 'armGroupLabels': ['SEP-363856']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Research Center, Inc.', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Innovations Inc.', 'geoPoint': {'lat': 33.88168, 'lon': -118.11701}}, {'zip': '90230', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'ProScience Research Group', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Research, LLC', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '91945', 'city': 'Lemon Grove', 'state': 'California', 'country': 'United States', 'facility': 'Synergy San Diego', 'geoPoint': {'lat': 32.74255, 'lon': -117.03142}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Innovations, Inc', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '92102', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92071', 'city': 'Santee', 'state': 'California', 'country': 'United States', 'facility': 'CMB Clinical Trials', 'geoPoint': {'lat': 32.83838, 'lon': -116.97392}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Cenexel CNS Research', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Larkin Behavioral Health Services', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33122', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Premier Clinical Research Institute, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Wellness Research Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Nova Psychiatry, Inc.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Advanced Discovery Research LLC', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30358', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Behavioral Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Uptown Research', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20877', 'city': 'Gaithersburg', 'state': 'Maryland', 'country': 'United States', 'facility': 'CBH Health', 'geoPoint': {'lat': 39.14344, 'lon': -77.20137}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'PsychCare Consultants Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'IMA Clinical Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hassman Research Institute', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '28211', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'New Hope Clinical Research', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Trials of America, LLC', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '44125', 'city': 'Garfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Charak Clinical Research Center', 'geoPoint': {'lat': 41.417, 'lon': -81.60596}}, {'zip': '75080', 'city': 'Richardson', 'state': 'Texas', 'country': 'United States', 'facility': 'Pillar Clinical Research, LLC', 'geoPoint': {'lat': 32.94818, 'lon': -96.72972}}]}, 'ipdSharingStatementModule': {'url': 'http://clinical-trials.otsuka.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.', 'ipdSharing': 'YES', 'description': 'Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.', 'accessCriteria': 'Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}