Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02634320
Status:
COMPLETED
Last Update Posted:
2018-12-04
First Post:
2015-12-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603935', 'term': 'aripiprazole lauroxil'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'usmedinfo@alkermes.com', 'phone': '866-204-7823', 'title': 'ARISTADA Medical Information', 'organization': 'Alkermes, Inc.'}, 'certainAgreement': {'otherDetails': 'Should an Investigator desire to disclose study results, Sponsor will review the results disclosure prior to public release and can embargo the disclosure for a period of at least 60 days. Revisions to the disclosure will be negotiated in good faith. For a multicenter study the Investigators agree to publish/publicly present the results together with the other sites for the 12 month period after study results are available unless Sponsor grants written permission in advance.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 7 months', 'eventGroups': [{'id': 'EG000', 'title': 'Aripiprazole Lauroxil', 'description': 'Intramuscular (IM) injection\n\nAripiprazole Lauroxil: Monthly IM injection', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 3, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V19'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole Lauroxil', 'description': 'Intramuscular (IM) injection\n\nAripiprazole Lauroxil: Monthly IM injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.87', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.078', 'groupIds': ['OG000'], 'pValueComment': 'Change from baseline at last on-treatment visit', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Statistical test is to confirm the change from baseline is statistically different from 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 months', 'description': 'The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to last visit in the treatment period based on the observed data.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population includes all subjects who received at least 1 dose of study drug and had a last on-treatment visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole Lauroxil', 'description': 'Intramuscular (IM) injection\n\nAripiprazole Lauroxil: Monthly IM injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'spread': '9.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 months', 'description': 'The BPRS is an instrument for evaluating change in psychopathology in patients with schizophrenia. It consists of 18 items in which clinicians rate patient symptoms on a 7-point scale (1=not present, 7=extremely severe). Scores range from 18 to 126, with higher scores indicative of more severe psychopathology).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population includes all subjects who received at least 1 dose of study drug and had a last on-treatment visit.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole Lauroxil', 'description': 'Intramuscular (IM) injection\n\nAripiprazole Lauroxil: Monthly IM injection'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population includes all subjects who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole Lauroxil', 'description': 'Intramuscular (IM) injection\n\nAripiprazole Lauroxil: Monthly IM injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '13.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 months', 'description': 'The QLS is a clinician-rated scale that is used to assess health-related quality of life and functioning in patients with schizoprehnia during the preceding 4 weeks. The QLS consists of 21 items in 4 major domains (Intrapsychic Foundations, Interpersonal Relations, Instrumental Role, and Common Objects and Activities). Following a semi-structured interview, each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who had at least one dose of study drug and had a last on-treatment visit.'}, {'type': 'SECONDARY', 'title': 'Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole Lauroxil', 'description': 'Intramuscular (IM) injection\n\nAripiprazole Lauroxil: Monthly IM injection'}], 'classes': [{'title': 'Spent at least 1 overnight as an inpatient', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Attended an outpatient visit for mental health', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Had at least 1 visit to an ER', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Were arrested, picked up, or transported by police', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 months', 'description': 'Responses to 4 mTSR-6 questions have been provided. Results include the number of participants who responded positively to the category during the entire post-baseline treatment period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole Lauroxil', 'description': 'Intramuscular (IM) injection\n\nAripiprazole Lauroxil: Monthly IM injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '12.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 months', 'description': 'The BAS is a 19-item scale completed by the caregiver that focuses on specific subjective and objective consequences of families caring for individuals with severe mental disorders. Respondents are required to indicate whether they have experienced each of the types of burden - \'Not at all\', \'A little\', \'Some\' or "A lot\' - in the previous four weeks. These are scored 1, 2, 3 and 4, respectively. The total score ranges between 19 and 76. A higher score indicates more perceived burden. Subjects required a reliable informant (caregiver) in order to participate in the study. These caregivers did not receive study treatment, and they are not represented elsewhere in the results data. The data provided indicates the change from baseline to the last treatment visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received at least one dose of study drug, had a last on-treatment visit, and had an unpaid caregiver providing information.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aripiprazole Lauroxil', 'description': 'Intramuscular (IM) injection\n\nAripiprazole Lauroxil: Monthly IM injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Moved out of area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Out of window for study visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects had schizophrenia, and had been taking paliperidone palmitate (PP) or Risperidone long-acting injection (RLAI) with inadequate results for at least 3 doses prior to screening.', 'preAssignmentDetails': 'All subjects received 4 to 6 doses of aripiprazole lauroxil in monthly or 6-week intervals.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aripiprazole Lauroxil', 'description': 'Intramuscular (IM) injection\n\nAripiprazole Lauroxil: Monthly IM injection'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '11.74', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '37', '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': '25', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety population included all subjects who received at least one dose of study drug. All analyses were performed on the Safety population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-07', 'size': 1352177, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-11T20:40', 'hasProtocol': True}, {'date': '2017-07-18', 'size': 312109, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-11T20:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-09', 'studyFirstSubmitDate': '2015-12-16', 'resultsFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2015-12-16', 'lastUpdatePostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-09', 'studyFirstPostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores', 'timeFrame': 'Up to 7 months', 'description': 'The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to last visit in the treatment period based on the observed data.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores', 'timeFrame': 'Up to 7 months', 'description': 'The BPRS is an instrument for evaluating change in psychopathology in patients with schizophrenia. It consists of 18 items in which clinicians rate patient symptoms on a 7-point scale (1=not present, 7=extremely severe). Scores range from 18 to 126, with higher scores indicative of more severe psychopathology).'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Up to 7 months'}, {'measure': 'Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS)', 'timeFrame': 'Up to 7 months', 'description': 'The QLS is a clinician-rated scale that is used to assess health-related quality of life and functioning in patients with schizoprehnia during the preceding 4 weeks. The QLS consists of 21 items in 4 major domains (Intrapsychic Foundations, Interpersonal Relations, Instrumental Role, and Common Objects and Activities). Following a semi-structured interview, each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning).'}, {'measure': 'Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)', 'timeFrame': 'Up to 7 months', 'description': 'Responses to 4 mTSR-6 questions have been provided. Results include the number of participants who responded positively to the category during the entire post-baseline treatment period.'}, {'measure': 'Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)', 'timeFrame': 'Up to 7 months', 'description': 'The BAS is a 19-item scale completed by the caregiver that focuses on specific subjective and objective consequences of families caring for individuals with severe mental disorders. Respondents are required to indicate whether they have experienced each of the types of burden - \'Not at all\', \'A little\', \'Some\' or "A lot\' - in the previous four weeks. These are scored 1, 2, 3 and 4, respectively. The total score ranges between 19 and 76. A higher score indicates more perceived burden. Subjects required a reliable informant (caregiver) in order to participate in the study. These caregivers did not receive study treatment, and they are not represented elsewhere in the results data. The data provided indicates the change from baseline to the last treatment visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alkermes', 'ARISTADA', 'Aripiprazole Lauroxil', 'Schizophrenia'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '38495608', 'type': 'DERIVED', 'citation': 'Opler MGA, Claxton A, McGrory J, Gasper S, Wang M, Yagoda S. Functioning and Cognition in Patients with Schizophrenia After Initiating Treatment with Aripiprazole Lauroxil: Secondary Outcomes and Post Hoc Analysis. Innov Clin Neurosci. 2024 Mar 1;21(1-3):43-51. eCollection 2024 Jan-Mar.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as ARISTADA, ALKS 9070).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has demonstrated tolerability to test doses of oral aripiprazole during screening; OR has a history of tolerated use of aripiprazole\n* Has a diagnosis of schizophrenia\n* Is clinically stable\n* Has received at least 3 doses of risperidone long acting injection (Risperdal Consta) or paliperidone palmitate (Invega Sustenna) prior to screening.\n* Has no antipsychotic medication regimen change for 4 weeks prior to Day 1\n* Agreed to abide by the contraceptive requirements o the protocol\n* Resides in a stable living situation\n* Additional criteria may apply\n\nExclusion Criteria:\n\n* Is currently pregnant or breastfeeding, or is planning to become pregnant during the study\n* Has received Invega Trinza, aripiprazole lauroxil, or IM depot aripiprazole within 6 months of screening\n* Has participated in a clinical trial involving any investigational product within the past 3 months, or is currently participating in a clinical trial involving an investigational product\n* Has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine, methadone, opiates, phencyclidine at screening\n* Additional criteria may apply'}, 'identificationModule': {'nctId': 'NCT02634320', 'briefTitle': 'A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'Safety and Tolerability of Initiating Aripiprazole Lauroxil in Subjects With Schizophrenia Who Are Inadequately Treated With Paliperidone Palmitate or Risperidone Long Acting Injection', 'orgStudyIdInfo': {'id': 'ALK9072-A401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Aripiprazole Lauroxil', 'description': 'Intramuscular (IM) injection', 'interventionNames': ['Drug: Aripiprazole Lauroxil']}], 'interventions': [{'name': 'Aripiprazole Lauroxil', 'type': 'DRUG', 'otherNames': ['ARISTADA'], 'description': 'Monthly IM injection', 'armGroupLabels': ['Aripiprazole Lauroxil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27711', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90230', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '91402', 'city': 'Panorama City', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 34.22473, 'lon': -118.44981}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '71101', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '44125', 'city': 'Garfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 41.417, 'lon': -81.60596}}, {'zip': '02865', 'city': 'Lincoln', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 41.92111, 'lon': -71.435}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75243', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75115', 'city': 'DeSoto', 'state': 'Texas', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 32.58986, 'lon': -96.85695}}], 'overallOfficials': [{'name': 'Sanjeev Pathak, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alkermes, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}