Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT01626456
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2012-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
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': 'usmedinfo@alkermes.com', 'phone': '866-274-7823', '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': 'Adverse events were collected at every study visit for 1 year (365 days).', 'eventGroups': [{'id': 'EG000', 'title': 'ALKS 9072, Low', 'description': 'ALKS 9072, Low: IM injection, given monthly', 'otherNumAtRisk': 110, 'otherNumAffected': 16, 'seriousNumAtRisk': 110, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ALKS 9072, High', 'description': 'ALKS 9072, High: IM injection, given monthly', 'otherNumAtRisk': 368, 'otherNumAffected': 59, 'seriousNumAtRisk': 368, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 45, 'numAffected': 37}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Somatoform disorder cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ALKS 9072, Low', 'description': 'ALKS 9072, Low: IM injection, given monthly'}, {'id': 'OG001', 'title': 'ALKS 9072, High', 'description': 'ALKS 9072, High: IM injection, given monthly'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'This measure includes incidences \\>5%.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population includes all subjects who receive at least 1 dose of ALKS 9072 in the current study.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}, {'value': '233', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PBO-441 mg', 'description': 'Subjects who received placebo in the base study and low dose in the current study.'}, {'id': 'OG001', 'title': '441-441 mg', 'description': 'Subjects who received low dose in both the base study and the current study.'}, {'id': 'OG002', 'title': 'PBO-882 mg', 'description': 'Subjects who received placebo in the base study and high dose in the current study.'}, {'id': 'OG003', 'title': '882-882 mg', 'description': 'Subjects who received high dose in both the base study and the current study.'}, {'id': 'OG004', 'title': 'De Novo', 'description': 'Subjects who did not participate in the base study. These subjects received high dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.85', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.61', 'groupId': 'OG003'}, {'value': '-0.2', 'spread': '0.61', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', '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 Day 365 based on the observed data.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consists of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS score after administration of ALKS 9072.'}, {'type': 'SECONDARY', 'title': 'Discontinuation From Study Due to Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ALKS 9072, Low', 'description': 'ALKS 9072, Low: IM injection, given monthly'}, {'id': 'OG001', 'title': 'ALKS 9072, High', 'description': 'ALKS 9072, High: IM injection, given monthly'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'Number of subjects who discontinued the study due to AE.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.'}, {'type': 'SECONDARY', 'title': 'Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '242', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PBO-440 mg', 'description': 'Subjects who received placebo in the base study and low dose in the current study'}, {'id': 'OG001', 'title': '441-441 mg', 'description': 'Subjects who received low dose in the base study and in the current study.'}, {'id': 'OG002', 'title': 'PBO-882 mg', 'description': 'Subjects who received placebo in the base study and high dose in the current study.'}, {'id': 'OG003', 'title': '882-882 mg', 'description': 'Subjects who received high dose in the base study and the current study.'}, {'id': 'OG004', 'title': 'De Novo', 'description': 'Subjects who did not participate in the base study.'}], 'classes': [{'title': 'Any suicidal ideation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Any suicidal behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.'}, {'type': 'SECONDARY', 'title': 'Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '242', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PBO-441 mg', 'description': 'Subjects who received placebo in the base study and low dose in the current study.'}, {'id': 'OG001', 'title': '441-441 mg', 'description': 'Subjects who received low dose in both the base study and the current study.'}, {'id': 'OG002', 'title': 'PBO-882 mg', 'description': 'Subjects who received placebo in the base study and high dose in the current study.'}, {'id': 'OG003', 'title': '882-882 mg', 'description': 'Subjects who received high dose in both the base study and the current study.'}, {'id': 'OG004', 'title': 'De Novo', 'description': 'Subjects who did not participate in the base study. These subjects received high dose.'}], 'classes': [{'title': 'Akathisia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}, {'title': 'Tremor', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Glycosylated haemoglobin increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'Includes incidence \\>2% but \\<5%.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}, {'value': '233', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PBO-441 mg', 'description': 'Subjects who received placebo in the base study and low dose in the current study.'}, {'id': 'OG001', 'title': '441-441 mg', 'description': 'Subjects who received low dose in both the base study and the current study.'}, {'id': 'OG002', 'title': 'PBO-882 mg', 'description': 'Subjects who received placebo in the base study and high dose in the current study.'}, {'id': 'OG003', 'title': '882-882 mg', 'description': 'Subjects who received high dose in both the base study and the current study.'}, {'id': 'OG004', 'title': 'De Novo', 'description': 'Subjects who did not participate in the base study. These subjects received high dose.'}], 'classes': [{'title': 'Total Score', 'categories': [{'measurements': [{'value': '-19.1', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '-10.0', 'spread': '10.2', 'groupId': 'OG001'}, {'value': '-11.6', 'spread': '11.7', 'groupId': 'OG002'}, {'value': '-8.3', 'spread': '8.2', 'groupId': 'OG003'}, {'value': '-5.9', 'spread': '8.3', 'groupId': 'OG004'}]}]}, {'title': 'Positive Subscale Score', 'categories': [{'measurements': [{'value': '-5.8', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '-4.1', 'spread': '4.1', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '3.1', 'groupId': 'OG003'}, {'value': '-1.8', 'spread': '2.8', 'groupId': 'OG004'}]}]}, {'title': 'Negative Subscale Score', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '3.8', 'groupId': 'OG002'}, {'value': '-2.1', 'spread': '3.0', 'groupId': 'OG003'}, {'value': '-1.2', 'spread': '3.3', 'groupId': 'OG004'}]}]}, {'title': 'General Psychopathology Subscale Score', 'categories': [{'measurements': [{'value': '-9.2', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '6.1', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': '4.7', 'groupId': 'OG003'}, {'value': '-2.9', 'spread': '4.7', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consisted of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS total score after administration of ALKS 9072.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ALKS 9072, Low', 'description': 'ALKS 9072, Low: IM injection, given monthly'}, {'id': 'FG001', 'title': 'ALKS 9072, High', 'description': 'ALKS 9072, High: IM injection, given monthly'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '368'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '251'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '117'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Site Closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Incarceration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects who successfully completed the Day 85 visit in Study ALK9072-003 and continued to meet eligibility criteria were eligible to enroll in this extension study. In addition, adults with chronic stable schizophrenia on a stable oral antipsychotic medication not previously enrolled in Study ALK9072-003 were also eligible to enroll.', 'preAssignmentDetails': 'While there were only 2 treatment groups in this extension study (low dose and high dose), data for several outcome measures is presented by lead-in study groups, and separated into 5 categories: PBO-441 mg, 441-441 mg, PBO-882 mg, 882-882 mg, and de novo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '368', 'groupId': 'BG001'}, {'value': '478', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ALKS 9072, Low', 'description': 'ALKS 9072, Low: IM injection, given monthly'}, {'id': 'BG001', 'title': 'ALKS 9072, High', 'description': 'ALKS 9072, High: IM injection, given monthly'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '10.88', 'groupId': 'BG000'}, {'value': '39.8', 'spread': '11.76', 'groupId': 'BG001'}, {'value': '39.4', 'spread': '11.57', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '275', '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': '20', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '305', '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': 'Russian Federation', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}, {'title': 'Philippines', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Malaysia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety population includes all subjects who receive at least 1 dose of ALKS 9072 in the current study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 478}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2012-06-15', 'resultsFirstSubmitDate': '2016-04-29', 'studyFirstSubmitQcDate': '2012-06-20', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-08', 'studyFirstPostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': '52 weeks', 'description': 'This measure includes incidences \\>5%.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)', 'timeFrame': '52 weeks', '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 Day 365 based on the observed data.'}, {'measure': 'Discontinuation From Study Due to Adverse Events (AEs)', 'timeFrame': '52 weeks', 'description': 'Number of subjects who discontinued the study due to AE.'}, {'measure': 'Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': '52 weeks', 'description': 'The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.'}, {'measure': 'Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests', 'timeFrame': '52 weeks', 'description': 'Includes incidence \\>2% but \\<5%.'}, {'measure': 'Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores', 'timeFrame': '52 weeks', 'description': 'This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '28350572', 'type': 'RESULT', 'citation': 'Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691.'}, {'pmid': '33761928', 'type': 'DERIVED', 'citation': "McEvoy JP, Weiden PJ, Lysaker PH, Sun X, O'Sullivan AK. Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia. BMC Psychiatry. 2021 Mar 24;21(1):164. doi: 10.1186/s12888-021-03124-2."}, {'pmid': '32841554', 'type': 'DERIVED', 'citation': 'Lauriello J, Claxton A, Du Y, Weiden PJ. Beyond 52-Week Long-Term Safety: Long-Term Outcomes of Aripiprazole Lauroxil for Patients With Schizophrenia Continuing in an Extension Study. J Clin Psychiatry. 2020 Aug 18;81(5):19m12835. doi: 10.4088/JCP.19m12835.'}, {'pmid': '30109845', 'type': 'DERIVED', 'citation': 'Nasrallah HA, Aquila R, Du Y, Stanford AD, Claxton A, Weiden PJ. Long-term safety and tolerability of aripiprazole lauroxil in patients with schizophrenia. CNS Spectr. 2019 Aug;24(4):395-403. doi: 10.1017/S1092852918001104. Epub 2018 Aug 15.'}, {'pmid': '29941057', 'type': 'DERIVED', 'citation': 'Weiden PJ, Du Y, Liu CC, Stanford AD. Switching stable patients with schizophrenia from their oral antipsychotics to aripiprazole lauroxil: a post hoc safety analysis of the initial 12-week crossover period. CNS Spectr. 2019 Aug;24(4):419-425. doi: 10.1017/S1092852918000986. Epub 2018 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(Subjects who participated in ALK9072-003)\n\n* Completed the ALK9072-003 Day 85 visit\n* Continues to require treatment with an antipsychotic medication\n\n(New Subjects)\n\n* On a stable dose of oral antipsychotic medication\n* Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable\n* Has been able to achieve outpatient status for more than 3 months prior to screening\n* Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)\n* Resides in a stable living situation\n\nExclusion Criteria:\n\n(Subjects who participated in ALK9072-003)\n\n* Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug\n* Missed more than 1 scheduled study visit during participation in study ALK9072-003\n* Has a significant or unstable medical condition that would preclude safe completion of the current study\n* Subject is pregnant or breastfeeding\n* Subject expects to be incarcerated in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures\n\n(New Subjects)\n\n* History of poor or inadequate clinical response to treatment with aripiprazole\n* History of treatment resistance\n* Diagnosis of current substance dependence (including alcohol)\n* Pregnant, lactating, or breastfeeding\n* Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening\n* Currently under involuntary hospitalization\n* Current or expected incarceration\n\nAdditional inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01626456', 'briefTitle': 'A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia', 'orgStudyIdInfo': {'id': 'ALK9072-003EXT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALKS 9072, Low', 'interventionNames': ['Drug: ALKS 9072, Low']}, {'type': 'EXPERIMENTAL', 'label': 'ALKS 9072, High', 'interventionNames': ['Drug: ALKS 9072, High']}], 'interventions': [{'name': 'ALKS 9072, Low', 'type': 'DRUG', 'description': 'IM injection, given monthly', 'armGroupLabels': ['ALKS 9072, Low']}, {'name': 'ALKS 9072, High', 'type': 'DRUG', 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