Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT02161718
Status:
COMPLETED
Last Update Posted:
2021-10-08
First Post:
2014-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000606131', 'term': '3-carboxamido-4-hydroxynaltrexone'}, {'id': 'D000077152', 'term': 'Olanzapine'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Gretchen.Murphy@alkermes.com', 'phone': '781-609-7000', 'title': 'Director, Corporate and R&D Communications', 'organization': 'Alkermes'}, '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 are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Open- Label ALKS 3831', 'description': 'A 2-week open-label period; all subjects received olanzapine (dose determined by investigator) + 10 mg samidorphan', 'otherNumAtRisk': 255, 'deathsNumAtRisk': 255, 'otherNumAffected': 0, 'seriousNumAtRisk': 255, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Olanzapine + Placebo', 'description': 'All randomized subjects who received at least 1 dose of study drug (olanzapine + placebo) during the double-blind treatment period', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 19, 'seriousNumAtRisk': 117, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'ALKS 3831', 'description': 'All randomized subjects who received at least 1 dose of ALKS 3831 (olanzapine + samidorphan) during the double-blind treatment period.', 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 26, 'seriousNumAtRisk': 112, 'deathsNumAffected': 1, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrocardiogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Schizophrenia, paranoid type', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Disturbance in social behavior', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ALKS 3831', 'description': 'Oral tablet, taken once daily\n\nALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)'}, {'id': 'OG001', 'title': 'Olanzapine + Placebo', 'description': 'Oral tablet, taken once daily\n\nOlanzapine dose level determined by investigator'}], 'classes': [{'title': 'Number of Subjects with IAC Adjudicated EEDS', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Number of Subjects Censored', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.746', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.251', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 15 months', 'description': "EEDS was defined as any of the following occurring during the double-blind period \\& was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC):\n\n1. Hospitalization (includes psychiatric\\& treatment of alcohol intoxication/withdrawal)\n2. \\>= 25% or \\>= 15 point increase from randomization in PANSS total score\n3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following:\n\n3a. Score \\>= 5 for subjects at a 2nd ad hoc visit with a score \\<=3 at randomization 3b. Score \\>= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were carried out using the intent to treat (ITT) population, i.e. all randomized subjects who received at least one dose of study drug post-randomization'}, {'type': 'SECONDARY', 'title': 'Number of Events of Exacerbation of Disease (EEDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ALKS 3831', 'description': 'Oral tablet, taken once daily\n\nALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)'}, {'id': 'OG001', 'title': 'Olanzapine + Placebo', 'description': 'Oral tablet, taken once daily\n\nOlanzapine dose level determined by investigator'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.372', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.37', 'statisticalMethod': 'Andersen-Gill Recurrent-Event Cox Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 15 months', 'description': "EEDS was defined as any of the following occurring during the double-blind period \\& was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC):\n\n1. Hospitalization(includes psychiatric \\& treatment of alcohol intoxication/withdrawal)\n2. \\>= 25% or \\>= 15 point increase from randomization in PANSS total score\n3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following:\n\n3a. Score \\>= 5 for subjects at a 2nd ad hoc visit with a score \\<=3 at randomization 3b. Score \\>= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease", 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were carried out using the intent to treat (ITT) population, i.e. all randomized subjects who received at least one dose of study drug post-randomization'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ALKS 3831', 'description': 'Oral tablet, taken once daily\n\nALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)'}, {'id': 'OG001', 'title': 'Olanzapine + Placebo', 'description': 'Oral tablet, taken once daily\n\nOlanzapine dose level determined by investigator'}], 'classes': [{'categories': [{'title': '>= 1 Level Decrease from Baseline', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': '< 1 Level Decrease from Baseline', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.963', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.73', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'description': 'Alcohol consumption per day = (total number of drinks x 14 gram) / (total number of days)\n\nWHO criteria for risk of alcohol consumption on a single drinking day:\n\nAbstinence- Males: 0 g; Females- 0 g Low Risk- Males: 1-40 g; Females: 1-20 g Medium Risk- Males: 41- 60 g; Females: 21- 40 g High Risk- Males: 61-100 g; Females: 41-60 g Very High Risk- Males: \\>= 101 g; Females: \\>= 61 g', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were carried out using subjects from the intent to treat (ITT) population with postbaseline data on drinking habits.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open-label ALKS 3831', 'description': 'Oral tablet, taken once daily ALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)'}, {'id': 'FG001', 'title': 'ALKS 3831', 'description': 'Oral tablet, taken once daily\n\nALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)'}, {'id': 'FG002', 'title': 'Olanzapine + Placebo', 'description': 'Oral tablet, taken once daily\n\nOlanzapine dose level determined by investigator'}], 'periods': [{'title': 'Open-Label ALKS 3831 Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '255'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Failure to meet randomization criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Post- Randomization Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '112'}, {'groupId': 'FG002', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '59'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Non- compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Received prohibitive treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were adults with a diagnosis of schizophrenia and Alcohol Use Disorder (AUD). Subjects must also have recently experienced an exacerbation of disease symptoms (eg, hospitalization), but could not exceed a pre-defined level of symptom severity at the time of screening (as measured by assessments like the Positive and Negative Symptom Scale \\[PANSS\\] and Clinical Global Impression- Severity \\[CGI-S\\]).', 'preAssignmentDetails': 'After screening, subjects began a 4-week open-label olanzapine dosing period followed by a 2- week open-label ALKS 3831 period. Subjects who did not tolerate ALKS 3831 during the second open-label period were discontinued from the study prior to randomization. A total of 300 subjects were enrolled in the study, and 255 completed the open-label olanzapine period. 234 subjects were randomized following the open-label ALKS 3831 period, however, 5 subjects discontinued prior to receiving treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ALKS 3831', 'description': 'Oral tablet, taken once daily\n\nALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)'}, {'id': 'BG001', 'title': 'Olanzapine + Placebo', 'description': 'Oral tablet, taken once daily\n\nOlanzapine dose level determined by investigator'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.4', 'spread': '10.60', 'groupId': 'BG000'}, {'value': '45.1', 'spread': '10.22', 'groupId': 'BG001'}, {'value': '45.7', 'spread': '10.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '101', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '173.4', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '174.4', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '173.9', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '86.2', 'spread': '19.7', 'groupId': 'BG000'}, {'value': '86.8', 'spread': '18.1', 'groupId': 'BG001'}, {'value': '86.5', 'spread': '18.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '28.5', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '28.6', 'spread': '5.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI) Group', 'classes': [{'title': 'Underweight (<18.5)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Normal (18.5 to <25)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'Overweight (25 to <30)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Obese (>= 30)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-01', 'size': 2669327, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-10T11:45', 'hasProtocol': True}, {'date': '2017-01-20', 'size': 399361, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-10T11:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'dispFirstSubmitDate': '2018-02-28', 'completionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2014-05-28', 'dispFirstSubmitQcDate': '2018-02-28', 'resultsFirstSubmitDate': '2021-06-22', 'studyFirstSubmitQcDate': '2014-06-11', 'dispFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-14', 'studyFirstPostDateStruct': {'date': '2014-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS)', 'timeFrame': 'Up to 15 months', 'description': "EEDS was defined as any of the following occurring during the double-blind period \\& was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC):\n\n1. Hospitalization (includes psychiatric\\& treatment of alcohol intoxication/withdrawal)\n2. \\>= 25% or \\>= 15 point increase from randomization in PANSS total score\n3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following:\n\n3a. Score \\>= 5 for subjects at a 2nd ad hoc visit with a score \\<=3 at randomization 3b. Score \\>= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease"}], 'secondaryOutcomes': [{'measure': 'Number of Events of Exacerbation of Disease (EEDS)', 'timeFrame': 'Up to 15 months', 'description': "EEDS was defined as any of the following occurring during the double-blind period \\& was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC):\n\n1. Hospitalization(includes psychiatric \\& treatment of alcohol intoxication/withdrawal)\n2. \\>= 25% or \\>= 15 point increase from randomization in PANSS total score\n3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following:\n\n3a. Score \\>= 5 for subjects at a 2nd ad hoc visit with a score \\<=3 at randomization 3b. Score \\>= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease"}, {'measure': 'Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27)', 'timeFrame': '24 weeks', 'description': 'Alcohol consumption per day = (total number of drinks x 14 gram) / (total number of days)\n\nWHO criteria for risk of alcohol consumption on a single drinking day:\n\nAbstinence- Males: 0 g; Females- 0 g Low Risk- Males: 1-40 g; Females: 1-20 g Medium Risk- Males: 41- 60 g; Females: 21- 40 g High Risk- Males: 61-100 g; Females: 41-60 g Very High Risk- Males: \\>= 101 g; Females: \\>= 61 g'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alkermes', 'Schizophrenia', 'Alcohol Use Disorder', 'ALKS 3831'], 'conditions': ['Schizophrenia', 'Alcohol Use Disorder']}, 'referencesModule': {'references': [{'pmid': '32160422', 'type': 'RESULT', 'citation': "Brunette MF, Correll CU, O'Malley SS, McDonnell D, DiPetrillo L, Jiang Y, Simmons A, Silverman BL, Citrome L, Green AI. Olanzapine Plus Samidorphan (ALKS 3831) in Schizophrenia and Comorbid Alcohol Use Disorder: A Phase 2, Randomized Clinical Trial. J Clin Psychiatry. 2020 Mar 10;81(2):19m12786. doi: 10.4088/JCP.19m12786."}]}, 'descriptionModule': {'briefSummary': 'This double-blind, randomized study will evaluate the efficacy, safety and tolerability of ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a BMI between 18.0 and 40.0 kg/m2, inclusive\n* Has a diagnosis of schizophrenia\n* Has a diagnosis of alcohol use disorder (AUD)\n* Has experienced an acute exacerbation of schizophrenia within the past 6 months\n* Additional criteria may apply\n\nExclusion Criteria:\n\n* Is pregnant or breastfeeding\n* Had first lifetime psychotic episode less than 1 year before screening or has experienced only a single lifetime psychotic episode\n* Has a known or suspected intolerance, allergy, or hypersensitivity to olanzapine\n* Has current or pending legal charges with the potential for incarceration\n* Has a positive drug screen for opiates\n* Additional criteria may apply'}, 'identificationModule': {'nctId': 'NCT02161718', 'briefTitle': 'A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Phase 2, Efficacy, Safety and Tolerability Study of ALKS 3831 in Schizophrenia With Alcohol Use Disorder', 'orgStudyIdInfo': {'id': 'ALK3831-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Samidorphan + olanzapine (ALKS 3831)', 'description': 'Active study drug', 'interventionNames': ['Drug: Samidorphan + olanzapine (ALKS 3831)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + olanzapine', 'interventionNames': ['Drug: Placebo + olanzapine']}], 'interventions': [{'name': 'Samidorphan + olanzapine (ALKS 3831)', 'type': 'DRUG', 'description': 'Oral tablet, taken once daily', 'armGroupLabels': ['Samidorphan + olanzapine (ALKS 3831)']}, {'name': 'Placebo + olanzapine', 'type': 'DRUG', 'description': 'Oral tablet, taken once daily', 'armGroupLabels': ['Placebo + olanzapine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72764', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'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': 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