Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-31 @ 9:33 AM
Study NCT ID:
NCT05227703
Status:
COMPLETED
Last Update Posted:
2025-10-28
First Post:
2022-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 80 days for the Placebo group, 67.5 days for the Emraclidine 15 mg group, and 64.0 days for the Emraclidine 30 mg group.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 47, 'seriousNumAtRisk': 130, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Emraclidine 15mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 47, 'seriousNumAtRisk': 130, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Emraclidine 30mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.', 'otherNumAtRisk': 131, 'deathsNumAtRisk': 131, 'otherNumAffected': 50, 'seriousNumAtRisk': 131, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'SINUS TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'ABDOMINAL DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'TOOTHACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'TINEA PEDIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'TOOTH ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'BLOOD PRESSURE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'WEIGHT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'SUICIDAL IDEATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}], 'seriousEvents': [{'term': 'VISION BLURRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'NEUROLEPTIC MALIGNANT SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'ACUTE PSYCHOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'AGITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'PSYCHOTIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'SCHIZOPHRENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG001', 'title': 'Emraclidine 15mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG002', 'title': 'Emraclidine 30mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.1', 'groupId': 'OG000', 'lowerLimit': '-19.4', 'upperLimit': '-12.8'}, {'value': '-18.5', 'groupId': 'OG001', 'lowerLimit': '-22.0', 'upperLimit': '-15.0'}, {'value': '-14.2', 'groupId': 'OG002', 'lowerLimit': '-17.5', 'upperLimit': '-10.8'}]}]}], 'analyses': [{'pValue': '0.2925', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '2.1', 'pValueComment': 'Emraclidine 15 mg versus Placebo', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.30', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.3914', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '6.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.27', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Week 6', 'description': 'The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat population (mITT): All randomized participants who receive at least 1 dose of investigational medicinal product (IMP) and have both a baseline and at least 1 postbaseline PANSS assessment. Overall Number of Participants Analyzed includes participants with a non-missing value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG001', 'title': 'Emraclidine 15 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG002', 'title': 'Emraclidine 30 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.83', 'groupId': 'OG000', 'lowerLimit': '-1.03', 'upperLimit': '-0.64'}, {'value': '-1.05', 'groupId': 'OG001', 'lowerLimit': '-1.25', 'upperLimit': '-0.84'}, {'value': '-0.80', 'groupId': 'OG002', 'lowerLimit': '-1.00', 'upperLimit': '-0.60'}]}]}], 'analyses': [{'pValue': '0.1165', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.135', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.8265', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.134', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Week 6', 'description': 'The CGI-S captures clinician\'s response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician\'s answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. Negative changes from Baseline indicate less mental illness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT: All randomized participants who receive at least 1 dose of investigational medicinal product (IMP) and have both a baseline and at least 1 postbaseline PANSS assessment. Overall Number of Participants Analyzed includes participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG001', 'title': 'Emraclidine 15 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG002', 'title': 'Emraclidine 30 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'groupId': 'OG000', 'lowerLimit': '-6.9', 'upperLimit': '-3.1'}, {'value': '-6.8', 'groupId': 'OG001', 'lowerLimit': '-8.8', 'upperLimit': '-4.8'}, {'value': '-4.9', 'groupId': 'OG002', 'lowerLimit': '-6.8', 'upperLimit': '-2.9'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.5', 'groupId': 'OG000', 'lowerLimit': '-10.9', 'upperLimit': '-6.1'}, {'value': '-8.7', 'groupId': 'OG001', 'lowerLimit': '-11.2', 'upperLimit': '-6.3'}, {'value': '-7.5', 'groupId': 'OG002', 'lowerLimit': '-9.9', 'upperLimit': '-5.1'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-11.2', 'groupId': 'OG000', 'lowerLimit': '-13.8', 'upperLimit': '-8.5'}, {'value': '-12.5', 'groupId': 'OG001', 'lowerLimit': '-15.3', 'upperLimit': '-9.7'}, {'value': '-10.0', 'groupId': 'OG002', 'lowerLimit': '-12.6', 'upperLimit': '-7.3'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-12.8', 'groupId': 'OG000', 'lowerLimit': '-15.5', 'upperLimit': '-10.1'}, {'value': '-13.4', 'groupId': 'OG001', 'lowerLimit': '-16.3', 'upperLimit': '-10.5'}, {'value': '-12.0', 'groupId': 'OG002', 'lowerLimit': '-14.8', 'upperLimit': '-9.2'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-14.7', 'groupId': 'OG000', 'lowerLimit': '-17.7', 'upperLimit': '-11.6'}, {'value': '-16.5', 'groupId': 'OG001', 'lowerLimit': '-19.7', 'upperLimit': '-13.2'}, {'value': '-12.9', 'groupId': 'OG002', 'lowerLimit': '-16.0', 'upperLimit': '-9.8'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-16.1', 'groupId': 'OG000', 'lowerLimit': '-19.4', 'upperLimit': '-12.8'}, {'value': '-18.5', 'groupId': 'OG001', 'lowerLimit': '-22.0', 'upperLimit': '-15.0'}, {'value': '-14.2', 'groupId': 'OG002', 'lowerLimit': '-17.5', 'upperLimit': '-10.8'}]}]}], 'analyses': [{'pValue': '0.1167', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.14', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 1-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.9254', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '2.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.14', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 1-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.8792', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '2.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.55', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 2-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.5094', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '4.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.52', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 2-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.4487', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '2.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.76', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 3-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.4852', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '4.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.72', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 3-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.7593', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '3.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.86', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 4-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.6792', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '4.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.82', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 4-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.3983', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '2.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.10', 'groupDescription': 'Week 5-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.3859', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '5.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.07', 'groupDescription': 'Week 5-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.2925', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '2.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.30', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 6-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.3914', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '6.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.27', 'groupDescription': 'Week 6-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 3, 4, 5, and 6', 'description': 'The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT: All randomized participants who receive at least 1 dose of investigational medicinal product (IMP) and have both a baseline and at least 1 postbaseline PANSS assessment. Overall Number of Participants Analyzed includes participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at All Time Points in the Clinical Global Impression - Severity (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG001', 'title': 'Emraclidine 15 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG002', 'title': 'Emraclidine 30 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'groupId': 'OG000', 'lowerLimit': '-0.33', 'upperLimit': '-0.09'}, {'value': '-0.33', 'groupId': 'OG001', 'lowerLimit': '-0.46', 'upperLimit': '-0.21'}, {'value': '-0.21', 'groupId': 'OG002', 'lowerLimit': '-0.33', 'upperLimit': '-0.09'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'groupId': 'OG000', 'lowerLimit': '-0.56', 'upperLimit': '-0.28'}, {'value': '-0.42', 'groupId': 'OG001', 'lowerLimit': '-0.56', 'upperLimit': '-0.27'}, {'value': '-0.38', 'groupId': 'OG002', 'lowerLimit': '-0.52', 'upperLimit': '-0.24'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.55', 'groupId': 'OG000', 'lowerLimit': '-0.70', 'upperLimit': '-0.40'}, {'value': '-0.64', 'groupId': 'OG001', 'lowerLimit': '-0.80', 'upperLimit': '-0.48'}, {'value': '-0.49', 'groupId': 'OG002', 'lowerLimit': '-0.64', 'upperLimit': '-0.34'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.72', 'groupId': 'OG000', 'lowerLimit': '-0.88', 'upperLimit': '-0.55'}, {'value': '-0.74', 'groupId': 'OG001', 'lowerLimit': '-0.91', 'upperLimit': '-0.57'}, {'value': '-0.62', 'groupId': 'OG002', 'lowerLimit': '-0.79', 'upperLimit': '-0.46'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.78', 'groupId': 'OG000', 'lowerLimit': '-0.96', 'upperLimit': '-0.60'}, {'value': '-0.91', 'groupId': 'OG001', 'lowerLimit': '-1.10', 'upperLimit': '-0.72'}, {'value': '-0.69', 'groupId': 'OG002', 'lowerLimit': '-0.87', 'upperLimit': '-0.51'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.83', 'groupId': 'OG000', 'lowerLimit': '-1.03', 'upperLimit': '-0.64'}, {'value': '-1.05', 'groupId': 'OG001', 'lowerLimit': '-1.25', 'upperLimit': '-.084'}, {'value': '-0.80', 'groupId': 'OG002', 'lowerLimit': '-1.00', 'upperLimit': '-0.60'}]}]}], 'analyses': [{'pValue': '0.0865', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.073', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 1-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.9921', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.072', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 1-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.9720', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.091', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 2-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.6621', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.089', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 2-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.3617', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.101', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 3-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.5456', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.098', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 3-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.8459', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.110', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 4-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.3922', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.108', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 4-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.2915', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.122', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 5-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.4425', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.120', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 5-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.1165', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.135', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 6-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.8265', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.134', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 6-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 3, 4, 5, and 6', 'description': 'The CGI-S captures clinician\'s response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician\'s answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Baseline was defined as the last value obtained prior to initiation of Emraclidine. Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. Negative changes from Baseline indicate less mental illness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT: All randomized participants who receive at least 1 dose of investigational medicinal product (IMP) and have both a baseline and at least 1 postbaseline PANSS assessment. Overall Number of Participants Analyzed includes participants with available data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders at Week 6 (Responders Defined as ≥30% Reduction From Baseline in PANSS Total Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG001', 'title': 'Emraclidine 15 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG002', 'title': 'Emraclidine 30 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000'}, {'value': '23.8', 'groupId': 'OG001'}, {'value': '12.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4597', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.68', 'ciUpperLimit': '2.33', 'groupDescription': 'Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence interval, and p-value were from a logistic regression with treatment group, geographic region and baseline value as a covariate.'}, {'pValue': '0.1205', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.28', 'ciUpperLimit': '1.16', 'groupDescription': 'Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Odds ratio, 95% confidence interval, and p-value were from a logistic regression with treatment group, geographic region and baseline value as a covariate.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 6', 'description': "The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A PANSS responder is defined as a participant with at least a 30% change in PANSS total score compared to baseline at Week 6 or the early termination visit. If a subject discontinued and did not have an early termination visit, the subject's last assessment was considered.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT: All randomized participants who receive at least 1 dose of Emraclidine and have both a baseline and at least 1 postbaseline PANSS assessment. Overall Number of Participants Analyzed includes participants with a non-missing value.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG001', 'title': 'Emraclidine 15mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG002', 'title': 'Emraclidine 30mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'TESAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug until 28 days following last dose of study drug (up to Week 10)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG001', 'title': 'Emraclidine 15 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG002', 'title': 'Emraclidine 30 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'classes': [{'title': 'QTcF value: > 450 - 480 msec', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'QTcF value: > 480 - 500 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'QTcF value: > 500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'QTcF increase from baseline: > 30 - 60 msec', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'QTcF increase from baseline: > 60 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline; from first dose of study drug up to Week 6', 'description': 'Assessment of clinically significant changes in electrocardiogram measures measured by 12-lead ECG recording after the participant has been supine and at rest for at least 3 minutes.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG001', 'title': 'Emraclidine 15 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG002', 'title': 'Emraclidine 30 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline; from first dose of study drug up to Week 6', 'description': 'Clinical laboratory tests were performed at scheduled study visits, and the investigator recorded any clinically significant changes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes in Vital Sign Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG001', 'title': 'Emraclidine 15 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG002', 'title': 'Emraclidine 30 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'classes': [{'title': 'Supine Systolic Blood Pressure: < 90 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Supine Systolic Blood Pressure: > 140 mmHg and ≤ 160 mmHg', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Supine Systolic Blood Pressure: 160 mmHg and ≤ 200 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Supine Systolic Blood Pressure: > 200 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Orthostatic Change in Systolic Blood Pressure: ≥ 20 mmHg decrease', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Supine Diastolic Blood Pressure: < 50 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Supine Diastolic Blood Pressure: > 90 mmHg and ≤ 100 mmHg', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Supine Diastolic Blood Pressure: > 100 mmHg and ≤ 120 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Supine Diastolic Blood Pressure: > 120 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Orthostatic Change in Diastolic Blood Pressure: ≥ 10 mmHg decrease', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Supine Heart Rate: < 50 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Supine Heart Rate: ≥ 50 bpm and < 60 bpm', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Supine Heart Rate: > 100 bpm and ≤ 120 bpm', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Supine Heart Rate: > 120 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Temperature: < 36 °C', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Temperature: > 38 °C', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory Rate: < 12 breaths/min', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory Rate: > 20 breaths/min', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Weight: ≥ 7% decrease', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Weight: ≥ 7% increase', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline; from first dose of study drug up to Week 6', 'description': "Vital signs were obtained after the participant had been supine and at rest for 3 minutes and included temperature, systolic and diastolic blood pressure, respiratory rate, and heart rate. Participants' body weights were also measured and recorded.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG001', 'title': 'Emraclidine 15 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG002', 'title': 'Emraclidine 30 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'classes': [{'title': 'Clinically Significant Changes in Physical Examination', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Clinically Significant Changes in Neurological Examination', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline; from first dose of study drug up to Week 6', 'description': 'The number of participants with clinically significant changes in physical and neurological examination results was documented.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Suicide-Related Treatment-Emergent Events Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG001', 'title': 'Emraclidine 15 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG002', 'title': 'Emraclidine 30 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'classes': [{'title': 'Treatment-Emergent Suicidal Ideation Compared to Recent History', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-Emergent Serious Suicidal Ideation Compared to Recent History', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Emergence of Serious Suicidal Ideation Compared to Recent History', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Emergence of Suicidal Behavior Compared to all Prior History', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline; from first dose of study drug up to Week 6', 'description': 'The C-SSRS rates an individual\'s degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual\'s intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Simpson Angus Scale (SAS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG001', 'title': 'Emraclidine 15 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG002', 'title': 'Emraclidine 30 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.1'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}]}]}], 'analyses': [{'pValue': '0.0493', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 3-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.0226', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 3-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.6845', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 6-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.8950', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 6-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Weeks 3 and 6', 'description': 'The SAS consists of a list of 10 symptoms of parkinsonism. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items. Baseline was defined as the last value obtained prior to initiation of study drug. Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. Negative changes from Baseline indicate an improvement in symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP); participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Rating Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG001', 'title': 'Emraclidine 15 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG002', 'title': 'Emraclidine 30 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.1'}]}]}], 'analyses': [{'pValue': '0.5073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 3-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.4650', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 3-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.0672', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 6-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.8030', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 6-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Weeks 3 and 6', 'description': "The Abnormal Involuntary Movement Scale assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1-4), extremity movements (items 5 and 6), and trunk movements (item 7) are observed unobtrusively while the participant is at rest, and the investigator also makes global judgments on the participant's dyskinesias (items 8-10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the participant's dental status. The AIMS Movement Rating Score is defined as the sum of individual scores from items 1-7, ranging from 0 to 28. A lower score indicates less severe or absent abnormal movements. A negative change in the mean from baseline indicates improvement in the severity of abnormal involuntary movements.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP); participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Evaluation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG001', 'title': 'Emraclidine 15 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'OG002', 'title': 'Emraclidine 30 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg QD each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.0'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.0'}]}]}], 'analyses': [{'pValue': '0.8259', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 3-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.5936', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 3-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.0253', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'estimateComment': 'Emraclidine 15 mg - Placebo', 'groupDescription': 'Week 6-- Emraclidine 15 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}, {'pValue': '0.2710', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'estimateComment': 'Emraclidine 30 mg - Placebo', 'groupDescription': 'Week 6-- Emraclidine 30 mg versus Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Weeks 3 and 6', 'description': 'The BARS consists of 4 items related to akathisia: The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The fourth item, reported here, is the Global Clinical Evaluation Score. The Global Clinical Evaluation Score is evaluated using a 6-point scale, with a score of 0 representing the absence of symptoms and a score of 5 representing severe akathisia. A negative change from baseline indicates an improvement in symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP); participants with available data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'FG001', 'title': 'Emraclidine 15 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'FG002', 'title': 'Emraclidine 30 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '131'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'Non-Compliance with Study Schedule', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were randomly assigned at a ratio of 1:1:1 to one of three treatment groups (Emraclidine 15 mg QD, Emraclidine 30 mg QD, or Placebo). Randomization was stratified by geographic region (United States or all other countries).', 'preAssignmentDetails': 'The ITT population included all randomized participants and was used for the Demographic and Baseline Characteristics. The modified ITT (mITT) population included all randomized participants who received at least one dose of study drug, had a baseline assessment, and had at least 1 postbaseline PANSS assessment. The mITT population was used for the efficacy evaluations. The FAS included all randomized participants who receive at least one dose of study drug and was used for the safety analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '391', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received a single daily oral dose of Placebo each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'BG001', 'title': 'Emraclidine 15 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 15 mg each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'BG002', 'title': 'Emraclidine 30 mg QD', 'description': 'Participants received a single daily oral dose of Emraclidine 30 mg each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'spread': '12.18', 'groupId': 'BG000'}, {'value': '42.7', 'spread': '11.51', 'groupId': 'BG001'}, {'value': '41.5', 'spread': '10.76', 'groupId': 'BG002'}, {'value': '42.1', 'spread': '11.48', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '305', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '311', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '244', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population: all randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-15', 'size': 2611725, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-14T15:52', 'hasProtocol': True}, {'date': '2024-10-14', 'size': 5352013, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-13T16:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo-controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 391}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'dispFirstSubmitDate': '2025-04-02', 'completionDateStruct': {'date': '2024-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-14', 'studyFirstSubmitDate': '2022-01-27', 'resultsFirstSubmitDate': '2025-09-05', 'studyFirstSubmitQcDate': '2022-01-27', 'dispFirstPostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-14', 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score', 'timeFrame': 'Baseline through Week 6', 'description': 'The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S Score)', 'timeFrame': 'Baseline through Week 6', 'description': 'The CGI-S captures clinician\'s response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician\'s answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. Negative changes from Baseline indicate less mental illness.'}, {'measure': 'Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score', 'timeFrame': 'Baseline; Weeks 1, 2, 3, 4, 5, and 6', 'description': 'The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.'}, {'measure': 'Change From Baseline at All Time Points in the Clinical Global Impression - Severity (CGI-S) Score', 'timeFrame': 'Baseline; Weeks 1, 2, 3, 4, 5, and 6', 'description': 'The CGI-S captures clinician\'s response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician\'s answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Baseline was defined as the last value obtained prior to initiation of Emraclidine. Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. Negative changes from Baseline indicate less mental illness.'}, {'measure': 'Percentage of Responders at Week 6 (Responders Defined as ≥30% Reduction From Baseline in PANSS Total Score)', 'timeFrame': 'Baseline through Week 6', 'description': "The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A PANSS responder is defined as a participant with at least a 30% change in PANSS total score compared to baseline at Week 6 or the early termination visit. If a subject discontinued and did not have an early termination visit, the subject's last assessment was considered."}, {'measure': 'Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From first dose of study drug until 28 days following last dose of study drug (up to Week 10)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)', 'timeFrame': 'Baseline; from first dose of study drug up to Week 6', 'description': 'Assessment of clinically significant changes in electrocardiogram measures measured by 12-lead ECG recording after the participant has been supine and at rest for at least 3 minutes.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments', 'timeFrame': 'Baseline; from first dose of study drug up to Week 6', 'description': 'Clinical laboratory tests were performed at scheduled study visits, and the investigator recorded any clinically significant changes.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Vital Sign Measurements', 'timeFrame': 'Baseline; from first dose of study drug up to Week 6', 'description': "Vital signs were obtained after the participant had been supine and at rest for 3 minutes and included temperature, systolic and diastolic blood pressure, respiratory rate, and heart rate. Participants' body weights were also measured and recorded."}, {'measure': 'Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results', 'timeFrame': 'Baseline; from first dose of study drug up to Week 6', 'description': 'The number of participants with clinically significant changes in physical and neurological examination results was documented.'}, {'measure': 'Number of Participants With Suicide-Related Treatment-Emergent Events Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline; from first dose of study drug up to Week 6', 'description': 'The C-SSRS rates an individual\'s degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual\'s intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).'}, {'measure': 'Change From Baseline in Simpson Angus Scale (SAS) Total Score', 'timeFrame': 'Baseline; Weeks 3 and 6', 'description': 'The SAS consists of a list of 10 symptoms of parkinsonism. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items. Baseline was defined as the last value obtained prior to initiation of study drug. Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. Negative changes from Baseline indicate an improvement in symptoms.'}, {'measure': 'Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Rating Score', 'timeFrame': 'Baseline; Weeks 3 and 6', 'description': "The Abnormal Involuntary Movement Scale assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1-4), extremity movements (items 5 and 6), and trunk movements (item 7) are observed unobtrusively while the participant is at rest, and the investigator also makes global judgments on the participant's dyskinesias (items 8-10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the participant's dental status. The AIMS Movement Rating Score is defined as the sum of individual scores from items 1-7, ranging from 0 to 28. A lower score indicates less severe or absent abnormal movements. A negative change in the mean from baseline indicates improvement in the severity of abnormal involuntary movements."}, {'measure': 'Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Evaluation Score', 'timeFrame': 'Baseline; Weeks 3 and 6', 'description': 'The BARS consists of 4 items related to akathisia: The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The fourth item, reported here, is the Global Clinical Evaluation Score. The Global Clinical Evaluation Score is evaluated using a 6-point scale, with a score of 0 representing the absence of symptoms and a score of 5 representing severe akathisia. A negative change from baseline indicates an improvement in symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Schizophrenia Spectrum and Other Psychotic Disorders', 'Mental Disorders'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 6-week trial to evaluate the efficacy, safety, and tolerability of 2 fixed doses of CVL-231 (Emraclidine) (15 mg QD and 30 mg QD) in male and female adult participants who have schizophrenia and are experiencing an acute exacerbation of psychosis.', 'detailedDescription': 'The trial included up to a 15-day Screening Period (up to a maximum of 21 days allowed with approval of the medical monitor), a 45-day Inpatient Treatment Period, and a 28-day Follow-up Period. Each participant participated in the trial for up to approximately 13 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic Disorders.\n* CGI-S ≥4 (moderately to severely ill) at the time of signing the ICF and Baseline.\n* PANSS Total Score between 85 and 120, inclusive, at the time of signing the ICF and at Baseline.\n* Experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 60 days prior to signing the ICF.\n* Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.\n* Body mass index of 18.0 to 40.0 kg/m2 and a total body weight ≥50 kg (110 lbs).\n* Ability, in the opinion of the investigator, to understand the nature of the trial, participate in trial visits, and comply with protocol requirements.\n\nExclusion Criteria:\n\n* Current DSM-5 diagnosis other than schizophrenia (note: anxiety symptoms secondary to schizophrenia are allowed); Acute depressive symptoms within 30 days prior to signing the ICF that require treatment with an antidepressant are exclusory. Acute manic symptoms within 30 days prior to signing the ICF that require treatment with a mood stabilizer are exclusory.\n* Any of the following:\n\n * Schizophrenia considered resistant/refractory to antipsychotic treatment by history (failure to respond to 2 or more courses of adequate pharmacological treatment defined as an adequate dose per label and a treatment duration of at least 4 weeks)\n * History of response to clozapine treatment only or failure to respond to clozapine treatment\n* Any of the following regarding history of schizophrenia:\n\n * Time from initial onset of schizophrenia \\<2 years based on prior records or participant self-report\n * Presenting with an initial diagnosis of schizophrenia\n * Presenting for the first time with an acute psychotic episode requiring treatment\n* Reduction (improvement) in PANSS total score of ≥20% between Screening and Baseline.\n* Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.\n* Active central nervous system infection, demyelinating disease, degenerative neurological disease, brain tumor, prior hospitalization for severe head trauma, seizures (excluding febrile seizures in childhood), or any central nervous system disease deemed to be progressive during the course of the trial that may confound the interpretation of the trial results\n* Diagnosis of moderate to severe substance or alcohol-use disorder (excluding nicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing the ICF.\n* Risk for suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and investigator's clinical assessment.\n* Any condition that could possibly affect drug absorption.\n* Use of prohibited medications prior to randomization within the required wash-out period or likely to require prohibited concomitant therapy during the trial.\n* Clinically significant abnormal findings on the physical examination, medical history review, ECG, or clinical laboratory results at screening.\n* Positive pregnancy test result prior to receiving IMP. Note: female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of IMP are also excluded."}, 'identificationModule': {'nctId': 'NCT05227703', 'briefTitle': 'A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses (15 mg and 30 mg QD) of CVL-231 (Emraclidine) in Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis', 'orgStudyIdInfo': {'id': 'CVL-231-2002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CVL-231 15 mg, once daily (QD)', 'description': 'Oral Dose', 'interventionNames': ['Drug: Emraclidine 15 mg']}, {'type': 'EXPERIMENTAL', 'label': 'CVL-231 30 mg, once daily (QD)', 'description': 'Oral Dose', 'interventionNames': ['Drug: Emraclidine 30 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, once daily (QD)', 'description': 'Oral Dose', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Emraclidine 15 mg', 'type': 'DRUG', 'otherNames': ['CVL-231', 'ABBV-1231'], 'description': 'Emraclidine 15 mg, oral (tablet), once per day (QD) for 6 weeks', 'armGroupLabels': ['CVL-231 15 mg, once daily (QD)']}, {'name': 'Emraclidine 30 mg', 'type': 'DRUG', 'otherNames': ['CVL-231', 'ABBV-1231'], 'description': 'Emraclidine 30 mg, oral (tablet), QD for 6 weeks', 'armGroupLabels': ['CVL-231 30 mg, once daily (QD)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo, oral (tablet), QD for 6 weeks', 'armGroupLabels': ['Placebo, once daily (QD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72712-3873', 'city': 'Bentonville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Bentonville, Arkansas', 'geoPoint': {'lat': 36.37285, 'lon': -94.20882}}, {'zip': '90706-7079', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'facility': 'Bellflower, California', 'geoPoint': {'lat': 33.88168, 'lon': -118.11701}}, {'zip': '90631-3842', 'city': 'La Habra', 'state': 'California', 'country': 'United States', 'facility': 'La Habra, California', 'geoPoint': {'lat': 33.93196, 'lon': -117.94617}}, {'zip': '92103-2209', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego, California', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91403-1747', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Sherman Oaks, California', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '90504-4432', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Torrance, California', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '06519-1109', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New Haven, Connecticut', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33032-8187', 'city': 'Homestead', 'state': 'Florida', 'country': 'United States', 'facility': 'Homestead, Florida', 'geoPoint': {'lat': 25.46872, 'lon': -80.47756}}, {'zip': '33122-1335', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami, Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33016-1553', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Lakes, Florida', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33166-7225', 'city': 'Miami Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Springs, Florida', 'geoPoint': {'lat': 25.82232, 'lon': -80.2895}}, {'zip': '30331-2012', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta, Georgia', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31405-5701', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Savannah, Georgia', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60640-5017', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago, Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60641', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago, Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Berlin, New Jersey', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Marlton, New Jersey', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'zip': '28211-4849', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte, North Carolina', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '78754-5122', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin, Texas', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '1431', 'city': 'Sofia', 'state': 'Sofia-Grad', 'country': 'Bulgaria', 'facility': 'Sofia, Sofia-Grad', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '8000', 'city': 'Burgas', 'country': 'Bulgaria', 'facility': 'Burgas, Burgas', 'geoPoint': {'lat': 42.50651, 'lon': 27.46886}}, {'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Pleven, Pleven', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '1282', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Sofia, Sofia', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '6300', 'city': 'Kalocsa', 'state': 'Bács-Kiskun county', 'country': 'Hungary', 'facility': 'Kalocsa, Bács-Kiskun', 'geoPoint': {'lat': 46.52981, 'lon': 18.97283}}, {'zip': '9024', 'city': 'Győr', 'state': 'Győr-Moson-Sopron', 'country': 'Hungary', 'facility': 'Győr, Győr-Moson-Sopron', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Budapest, Budapest', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'Julie Adams', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}