Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT03745820
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2018-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600968', 'term': 'PF-04958242'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogen.com', 'phone': '866-633-4636', 'title': 'US Biogen Clinical Trial Center', 'organization': 'Biogen'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug through end of the study (up to Week 14)', 'description': 'The safety population included all randomized participants who received at least 1 dose of study treatment(BIIB104 or placebo).One participant randomized to placebo,inadvertently received one or more doses of active treatment. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 2, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'BIIB104 0.15 mg', 'description': 'Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 2, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'BIIB104 0.5 mg', 'description': 'Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 8, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Psychiatric decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Working Memory Domain Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BIIB104 0.15 mg', 'description': 'Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BIIB104 0.5 mg', 'description': 'Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.17', 'spread': '0.939', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.936', 'groupId': 'OG001'}, {'value': '0.84', 'spread': '0.934', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.8472', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-2.88', 'ciUpperLimit': '2.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.328', 'groupDescription': 'Mixed Model Repeated Measures(MMRM)model was used to analyze change from baseline of outcome measure(OM)using fixed effects of treatment group,region,study visit,study visit-by-treatment interaction,baseline value of OM,baseline-by-visit interaction.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.8053', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-2.94', 'ciUpperLimit': '2.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.323', 'groupDescription': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The MCCB is a cognitive battery that assesses 7 domains recommended by the MATRICS initiative (i.e., Working Memory, Verbal Learning, Speed of Processing, Attention/Vigilance, Visual Learning, Social Cognition, and Reasoning and Problem Solving). MCCB was administered via laptop computer and paper-and-pencil assessments. T-scores for the individual tests were calculated according to the developer's recommended scoring algorithms. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. The working memory domain score of the MCCB is reported in this outcome measure.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BIIB104 0.15 mg', 'description': 'Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BIIB104 0.5 mg', 'description': 'Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug through end of the study (up to Week 14)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized participants who received at least 1 dose of study treatment (BIIB104 or placebo).'}, {'type': 'SECONDARY', 'title': 'Mean Total Score Assessed by Scale for the Assessment and Rating of Ataxia (SARA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BIIB104 0.15 mg', 'description': 'Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BIIB104 0.5 mg', 'description': 'Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.92', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.68', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.58', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.72', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.69', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 6, 12 and safety follow-up (Week 14)', 'description': 'The SARA is a clinical scale that is based on a semiquantitative assessment of cerebellar ataxia on an impairment level and complements the brief neurological examination. The SARA scale is an eight-item clinical rating scale (gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test) with a total score range of 0-40, where 0 is the best neurological status and 40 is the worst neurological status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized participants who received at least 1 dose of study treatment (BIIB104 or placebo). Here, "Overall number of participants analyzed" signifies the number of participants analyzed in this outcome measure and "number analyzed" signifies the number of participants analyzed at specified time-point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Event of Suicidal Ideation and/or Suicidal Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BIIB104 0.15 mg', 'description': 'Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BIIB104 0.5 mg', 'description': 'Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 14', 'description': 'The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \\[not plan\\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 6-item scale: 1 (actual attempt), 2 (interrupted attempt), 3 (aborted attempt), 4 (preparatory acts or behavior), 5 (suicidal behavior), and 6 (suicide). The data analyzed signifies the participants with at least one event of suicidal ideation and/or suicidal behavior.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized participants who received at least 1 dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in University of California, San Diego Performance Based Skills Assessment-Brief International Version (UPSA-Bi) Assessment at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BIIB104 0.15 mg', 'description': 'Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BIIB104 0.5 mg', 'description': 'Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.07', 'spread': '1.303', 'groupId': 'OG000'}, {'value': '5.50', 'spread': '1.292', 'groupId': 'OG001'}, {'value': '5.49', 'spread': '1.305', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.0637', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.43', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '7.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.835', 'groupDescription': 'An analysis of covariance (ANCOVA) model was applied adjusting for treatment group and baseline value of the OM.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.0659', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.42', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '7.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.844', 'groupDescription': 'An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The UPSA-Bi, international version, an abbreviated version of the UPSA-Validation of Intermediate Measures, is a measure of functional capacity and assesses skills used in community tasks. This assessment measures 2 general skills that were previously identified as essential to functioning in the community: financial skills and communication skills. The UPSA-Bi assessment is scored from 0-100, higher scores indicating higher functional status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Assessment Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BIIB104 0.15 mg', 'description': 'Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BIIB104 0.5 mg', 'description': 'Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.146', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '0.148', 'groupId': 'OG001'}, {'value': '-0.41', 'spread': '0.145', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.6653', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.208', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.6140', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.206', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The SCoRS is an interview-based assessment of cognition that involves interviews with participants and informants. The SCoRS includes 20 items designed to specifically assess aspects of cognitive functioning found in each of the seven MCCB cognitive domains including the following: Memory: 4 items; Learning: 2 items; Attention: 3 items; Working memory: 2 items; Problem solving: 3 items; Processing/motor speed: 2 items; Social cognition: 3 items; Language: 1 item. Total score range is 20-80, lower scores indicating higher functional status. The data reported in this outcome measure are for global rating score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MCCB Neurocognitive Composite Scores at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BIIB104 0.15 mg', 'description': 'Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BIIB104 0.5 mg', 'description': 'Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.90', 'spread': '0.733', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '0.728', 'groupId': 'OG001'}, {'value': '3.39', 'spread': '0.727', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.2886', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.10', 'ciLowerLimit': '-3.14', 'ciUpperLimit': '0.94', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.033', 'groupDescription': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.6349', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '2.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.032', 'groupDescription': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The MCCB is a cognitive battery that assesses 7 domains recommended by the MATRICS initiative (i.e., Working Memory, Verbal Learning, Speed of Processing, Attention/Vigilance, Visual Learning, Social Cognition, and Reasoning and Problem Solving). MCCB was administered via laptop computer and paper-and-pencil assessments. T-scores for the individual tests were calculated according to the developer's recommended scoring algorithms. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. The MCCB composite score contains all of the tests and domains of the MCCB.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MCCB Individual Domain Scores (Excluding Working Memory Domain) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BIIB104 0.15 mg', 'description': 'Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BIIB104 0.5 mg', 'description': 'Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.'}], 'classes': [{'title': 'Verbal Learning: Change at Week 12', 'categories': [{'measurements': [{'value': '0.95', 'spread': '0.951', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.946', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.950', 'groupId': 'OG002'}]}]}, {'title': 'Speed of Processing: Change at Week 12', 'categories': [{'measurements': [{'value': '4.42', 'spread': '0.824', 'groupId': 'OG000'}, {'value': '2.28', 'spread': '0.819', 'groupId': 'OG001'}, {'value': '3.99', 'spread': '0.817', 'groupId': 'OG002'}]}]}, {'title': 'Attention/Vigilance: Change at Week 12', 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.852', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.848', 'groupId': 'OG001'}, {'value': '1.55', 'spread': '0.848', 'groupId': 'OG002'}]}]}, {'title': 'Visual Learning: Change at Week 12', 'categories': [{'measurements': [{'value': '1.70', 'spread': '1.131', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '1.125', 'groupId': 'OG001'}, {'value': '1.77', 'spread': '1.125', 'groupId': 'OG002'}]}]}, {'title': 'Social Cognition: Change at Week 12', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.959', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '0.953', 'groupId': 'OG001'}, {'value': '0.95', 'spread': '0.955', 'groupId': 'OG002'}]}]}, {'title': 'Reasoning and Problem Solving: Change at Week 12', 'categories': [{'measurements': [{'value': '2.81', 'spread': '1.019', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '1.1014', 'groupId': 'OG001'}, {'value': '4.40', 'spread': '1.011', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.7372', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '-2.21', 'ciUpperLimit': '3.11', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.345', 'groupDescription': 'Verbal Learning: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.6894', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-3.20', 'ciUpperLimit': '2.12', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.346', 'groupDescription': 'Verbal Learning: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.0674', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.14', 'ciLowerLimit': '-4.44', 'ciUpperLimit': '0.16', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.162', 'groupDescription': 'Speed of Processing: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.7132', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-2.72', 'ciUpperLimit': '1.87', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.161', 'groupDescription': 'Speed of Processing: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.9428', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-2.46', 'ciUpperLimit': '2.29', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.203', 'groupDescription': 'Attention/Vigilance: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.4425', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '-1.45', 'ciUpperLimit': '3.30', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.202', 'groupDescription': 'Attention/Vigilance: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.3455', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.51', 'ciLowerLimit': '-4.66', 'ciUpperLimit': '1.64', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.597', 'groupDescription': 'Visual Learning: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.9686', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-3.09', 'ciUpperLimit': '3.21', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.595', 'groupDescription': 'Visual Learning: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.3832', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '-1.49', 'ciUpperLimit': '3.85', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.351', 'groupDescription': 'Social Cognition: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.4297', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean DIfference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '-1.61', 'ciUpperLimit': '3.75', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.357', 'groupDescription': 'Social Cognition: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.6245', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-3.55', 'ciUpperLimit': '2.14', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.438', 'groupDescription': 'Reasoning and Problem Solving: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.2698', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '4.43', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.436', 'groupDescription': 'Reasoning and Problem Solving: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The MCCB is a cognitive battery that assesses 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, and reasoning and problem solving). MCCB was administered via laptop computer and paper-and-pencil assessments. T-scores for the individual tests were calculated according to the developer's recommended scoring algorithms. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. All the domain scores of the MCCB are reported in this outcome measure with the exception of working memory domain.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Subscale, and Negative Subscale Scores at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BIIB104 0.15 mg', 'description': 'Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BIIB104 0.5 mg', 'description': 'Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.'}], 'classes': [{'title': 'Positive Symptoms Subscale: Change From Baseline at Week 12', 'categories': [{'measurements': [{'value': '-0.65', 'spread': '0.431', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '0.430', 'groupId': 'OG001'}, {'value': '-0.98', 'spread': '0.429', 'groupId': 'OG002'}]}]}, {'title': 'Negative Symptoms Subscale: Change From Baseline at Week 12', 'categories': [{'measurements': [{'value': '-0.90', 'spread': '0.461', 'groupId': 'OG000'}, {'value': '-0.98', 'spread': '0.461', 'groupId': 'OG001'}, {'value': '-1.40', 'spread': '0.460', 'groupId': 'OG002'}]}]}, {'title': 'Total Score: Change From Baseline at Week 12', 'categories': [{'measurements': [{'value': '-3.06', 'spread': '1.429', 'groupId': 'OG000'}, {'value': '-4.26', 'spread': '1.421', 'groupId': 'OG001'}, {'value': '-5.03', 'spread': '1.427', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.4654', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-1.65', 'ciUpperLimit': '0.76', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.610', 'groupDescription': 'Positive Symptoms Subscale: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.5886', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-1.53', 'ciUpperLimit': '0.87', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.608', 'groupDescription': 'Positive Symptoms Subscale: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.9079', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-1.37', 'ciUpperLimit': '1.22', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.655', 'groupDescription': 'Negative Symptoms Subscale: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.4441', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-1.78', 'ciUpperLimit': '0.79', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.650', 'groupDescription': 'Negative Symptoms Subscale: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.5537', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.20', 'ciLowerLimit': '-5.18', 'ciUpperLimit': '2.79', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.017', 'groupDescription': 'Total Score: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.3320', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.96', 'ciLowerLimit': '-5.95', 'ciUpperLimit': '2.02', 'pValueComment': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.018', 'groupDescription': 'Total Score: Change From Baseline at Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The PANSS includes 3 subscales and 30 items: 7 items that make up the Positive subscale (e.g., delusions, conceptual disorganization, hallucinatory behaviour); 7 items that make up the Negative subscale (e.g., blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology subscale (e.g., somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Each item on the positive, negative and general psychopathology subscale is rated from 1 (absent) to 7 (extreme). The score range is 7-49 for positive and negative subscales, score range is 16-112 for the general psychopathology subscale. Total PANSS score (positive+ negative + general psychopathology subscale scores) range from 30 to 210. Higher scores represent more severity in symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scores at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BIIB104 0.15 mg', 'description': 'Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BIIB104 0.5 mg', 'description': 'Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.091', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.091', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.091', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.8517', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.128', 'groupDescription': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.9952', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.128', 'groupDescription': 'A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The CGI-S consists of a single 7-point rating score of illness severity. The following question: "Considering your total clinical experience with this particular population, how mentally ill is your participant at this time?" is rated with a score from 1 to 7- 1: Normal, not ill at all; 2: Borderline mentally ill; 3: Mildly ill; 4: Moderately ill; 5: Markedly ill; 6: Severely ill; or 7: Among the most severely ill participants. Lower scores indicate less severity of illness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response on Clinical Global Impression-Improvement (CGI-I) Scale at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BIIB104 0.15 mg', 'description': 'Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks.'}, {'id': 'OG002', 'title': 'BIIB104 0.5 mg', 'description': 'Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.'}], 'classes': [{'title': 'Very Much Improved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Much Improved', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Minimally Improved', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Minimally Worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Much Worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Very Much Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The CGI-I consists of a single 7-point rating score total improvement, regardless of whether or not the change is due entirely to drug treatment. The following question: "Compared to your participant\'s condition at the beginning of treatment, how much has your participant changed?" is rated with a score from 1 to 7- 1: Very much improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; or 7: Very much worse. Lower scores indicate greater improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received BIIB104 matching placebo capsules, twice a day (BID), orally for 12 weeks.'}, {'id': 'FG001', 'title': 'BIIB104 0.15 mg', 'description': 'Participants received 0.15 milligrams (mg) capsules of BIIB104, BID, orally for 12 weeks.'}, {'id': 'FG002', 'title': 'BIIB104 0.5 mg', 'description': 'Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '65'}]}, {'type': 'Safety Analysis Set', 'comment': 'The safety population included all randomized participants who received at least 1 dose of study treatment(BIIB104 or placebo). One participant randomized to placebo, inadvertently received one or more doses of active treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Physician decision unrelated to safety/efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 53 investigative sites in the United States, Japan, Spain, Germany, and the United Kingdom from 15 Nov 2018 to 07 April 2022.', 'preAssignmentDetails': 'A total of 554 participants were screened out of which, 195 participants were randomized and dosed to receive BIIB104 or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '195', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks.'}, {'id': 'BG001', 'title': 'BIIB104 0.15 mg', 'description': 'Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks.'}, {'id': 'BG002', 'title': 'BIIB104 0.5 mg', 'description': 'Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '9.47', 'groupId': 'BG000'}, {'value': '37.7', 'spread': '9.41', 'groupId': 'BG001'}, {'value': '41.3', 'spread': '9.63', 'groupId': 'BG002'}, {'value': '39.8', 'spread': '9.58', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'MATRICS Consensus Cognitive Battery (MCCB) Working Memory Domain Score', 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '70'}, {'value': '38.5', 'groupId': 'BG001', 'lowerLimit': '12', 'upperLimit': '60'}, {'value': '39.8', 'groupId': 'BG002', 'lowerLimit': '17', 'upperLimit': '58'}, {'value': '39.3', 'groupId': 'BG003', 'lowerLimit': '12', 'upperLimit': '70'}]}]}], 'paramType': 'MEAN', 'description': 'The MCCB is a cognitive battery that assesses 7 domains recommended by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative (i.e., Working Memory, Verbal Learning, Speed of Processing, Attention/Vigilance, Visual Learning, Social Cognition, and Reasoning and Problem Solving). MCCB was administered via laptop computer and paper-and-pencil assessments. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. The working memory domain score of the MCCB is reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-30', 'size': 3923256, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-23T03:22', 'hasProtocol': True}, {'date': '2022-03-30', 'size': 601709, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-23T01:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2018-11-15', 'resultsFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-23', 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Working Memory Domain Score at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': "The MCCB is a cognitive battery that assesses 7 domains recommended by the MATRICS initiative (i.e., Working Memory, Verbal Learning, Speed of Processing, Attention/Vigilance, Visual Learning, Social Cognition, and Reasoning and Problem Solving). MCCB was administered via laptop computer and paper-and-pencil assessments. T-scores for the individual tests were calculated according to the developer's recommended scoring algorithms. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. The working memory domain score of the MCCB is reported in this outcome measure."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From first dose of study drug through end of the study (up to Week 14)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event.'}, {'measure': 'Mean Total Score Assessed by Scale for the Assessment and Rating of Ataxia (SARA)', 'timeFrame': 'Baseline, Weeks 2, 6, 12 and safety follow-up (Week 14)', 'description': 'The SARA is a clinical scale that is based on a semiquantitative assessment of cerebellar ataxia on an impairment level and complements the brief neurological examination. The SARA scale is an eight-item clinical rating scale (gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test) with a total score range of 0-40, where 0 is the best neurological status and 40 is the worst neurological status.'}, {'measure': 'Number of Participants With at Least One Event of Suicidal Ideation and/or Suicidal Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score', 'timeFrame': 'Up to Week 14', 'description': 'The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \\[not plan\\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 6-item scale: 1 (actual attempt), 2 (interrupted attempt), 3 (aborted attempt), 4 (preparatory acts or behavior), 5 (suicidal behavior), and 6 (suicide). The data analyzed signifies the participants with at least one event of suicidal ideation and/or suicidal behavior.'}, {'measure': 'Change From Baseline in University of California, San Diego Performance Based Skills Assessment-Brief International Version (UPSA-Bi) Assessment at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The UPSA-Bi, international version, an abbreviated version of the UPSA-Validation of Intermediate Measures, is a measure of functional capacity and assesses skills used in community tasks. This assessment measures 2 general skills that were previously identified as essential to functioning in the community: financial skills and communication skills. The UPSA-Bi assessment is scored from 0-100, higher scores indicating higher functional status.'}, {'measure': 'Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Assessment Score at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The SCoRS is an interview-based assessment of cognition that involves interviews with participants and informants. The SCoRS includes 20 items designed to specifically assess aspects of cognitive functioning found in each of the seven MCCB cognitive domains including the following: Memory: 4 items; Learning: 2 items; Attention: 3 items; Working memory: 2 items; Problem solving: 3 items; Processing/motor speed: 2 items; Social cognition: 3 items; Language: 1 item. Total score range is 20-80, lower scores indicating higher functional status. The data reported in this outcome measure are for global rating score.'}, {'measure': 'Change From Baseline in MCCB Neurocognitive Composite Scores at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': "The MCCB is a cognitive battery that assesses 7 domains recommended by the MATRICS initiative (i.e., Working Memory, Verbal Learning, Speed of Processing, Attention/Vigilance, Visual Learning, Social Cognition, and Reasoning and Problem Solving). MCCB was administered via laptop computer and paper-and-pencil assessments. T-scores for the individual tests were calculated according to the developer's recommended scoring algorithms. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. The MCCB composite score contains all of the tests and domains of the MCCB."}, {'measure': 'Change From Baseline in MCCB Individual Domain Scores (Excluding Working Memory Domain) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': "The MCCB is a cognitive battery that assesses 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, and reasoning and problem solving). MCCB was administered via laptop computer and paper-and-pencil assessments. T-scores for the individual tests were calculated according to the developer's recommended scoring algorithms. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. All the domain scores of the MCCB are reported in this outcome measure with the exception of working memory domain."}, {'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Subscale, and Negative Subscale Scores at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The PANSS includes 3 subscales and 30 items: 7 items that make up the Positive subscale (e.g., delusions, conceptual disorganization, hallucinatory behaviour); 7 items that make up the Negative subscale (e.g., blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology subscale (e.g., somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Each item on the positive, negative and general psychopathology subscale is rated from 1 (absent) to 7 (extreme). The score range is 7-49 for positive and negative subscales, score range is 16-112 for the general psychopathology subscale. Total PANSS score (positive+ negative + general psychopathology subscale scores) range from 30 to 210. Higher scores represent more severity in symptoms.'}, {'measure': 'Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scores at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The CGI-S consists of a single 7-point rating score of illness severity. The following question: "Considering your total clinical experience with this particular population, how mentally ill is your participant at this time?" is rated with a score from 1 to 7- 1: Normal, not ill at all; 2: Borderline mentally ill; 3: Mildly ill; 4: Moderately ill; 5: Markedly ill; 6: Severely ill; or 7: Among the most severely ill participants. Lower scores indicate less severity of illness.'}, {'measure': 'Number of Participants With Response on Clinical Global Impression-Improvement (CGI-I) Scale at Week 12', 'timeFrame': 'Week 12', 'description': 'The CGI-I consists of a single 7-point rating score total improvement, regardless of whether or not the change is due entirely to drug treatment. The following question: "Compared to your participant\'s condition at the beginning of treatment, how much has your participant changed?" is rated with a score from 1 to 7- 1: Very much improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; or 7: Very much worse. Lower scores indicate greater improvement.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Impairment Associated With Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the efficacy of BIIB104 in participants with CIAS, using the Working Memory Domain of the MATRICS Consensus Cognitive Battery (MCCB).\n\nThe secondary objectives of this study are to evaluate the safety and tolerability of BIIB104 in participants with CIAS, and to evaluate the efficacy of BIIB104 in participants with CIAS on measures of cognition, functioning, and psychiatric symptomology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Otherwise healthy participant with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), diagnosis of schizophrenia of at least 2 years' duration as confirmed by the mini-international neuropsychiatric interview (MINI) 7.0.2 for Psychotic Disorders.\n* Evidence of stable schizophrenia symptomatology ≥12 weeks (e.g., no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of schizophrenia symptoms).\n* Participants must be in ongoing maintenance atypical antipsychotic therapy (except clozapine), on a stable treatment regimen for ≥8 weeks prior to Baseline/Day 1, including concomitant psychotropic medication. Doses of background atypical antipsychotics should be within the recommended dose range listed in the approved product labeling of the country where the study is being conducted.\n* SCI-PANSS: No more than moderate-severe rating (score ≤5) on delusions, hallucinatory behavior, grandiosity, suspiciousness / persecution, and hostility (i.e. PANSS, positive symptom items P1, P3, P5, P6, P7); or unusual thought content (G9); and no more than a moderate rating (score ≤4) on conceptual disorganization (P2).\n\nKey Exclusion Criteria:\n\n* Participation in a trial using any component or version of the MATRICS Consensus Cognitive Battery (MCCB) or the University of California, San Diego (UCSD) Performance-Based Skills Assessment test within the previous 6 months.\n* Participation in cognitive remediation therapy within 6 months prior to randomization.\n* Screening MCCB Working Memory Domain T-score ≥60.\n* Current DSM-5 diagnosis of schizoaffective disorder on the MINI 7.0.2 for Psychotic Disorders.\n* Current DSM-5 diagnosis of major depressive episode, manic and hypomanic episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, and/or generalized anxiety disorder on the MINI 7.0.2 for Psychotic Disorders.\n* Lifetime DSM-5 diagnosis of antisocial personality disorder, anorexia nervosa, bulimia nervosa, and/or binge-eating disorder on the MINI 7.0.2 for Psychotic Disorders.\n* Meets the DSM-5 diagnosis of moderate or severe substance use disorder (excluding nicotine dependence) within 12 months of screening on the MINI 7.0.2 for Psychotic Disorders interview.\n* DSM-5 diagnosis of Intellectual Disability (intellectual developmental disorder).\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT03745820', 'acronym': 'TALLY', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BIIB104 in Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)', 'orgStudyIdInfo': {'id': '263CS201'}, 'secondaryIdInfos': [{'id': '2018-003825-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIIB104 0.5 mg', 'description': 'Participants will receive 0.5 mg of BIIB104 twice a day, orally, for 12 weeks.', 'interventionNames': ['Drug: BIIB104']}, {'type': 'EXPERIMENTAL', 'label': 'BIIB104 0.15 mg', 'description': 'Participants will receive 0.15 mg of BIIB104 twice a day, orally, for 12 weeks.', 'interventionNames': ['Drug: BIIB104']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching Placebo', 'description': 'Participants will receive matching placebo twice a day, orally, for 12 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'BIIB104', 'type': 'DRUG', 'otherNames': ['PF-04958242'], 'description': 'Administered as specified in the treatment arm', 'armGroupLabels': ['BIIB104 0.15 mg', 'BIIB104 0.5 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Administered as specified in the treatment arm', 'armGroupLabels': ['Matching Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72712', 'city': 'Bentonville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Pillar Clinical Research, LLC', 'geoPoint': {'lat': 36.37285, 'lon': -94.20882}}, {'zip': '90230', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'ProScience Research Group', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network, LLC', 'geoPoint': {'lat': 33.77391, 'lon': 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