Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-25 @ 4:54 PM
Study NCT ID:
NCT04268303
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2020-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011595', 'term': 'Psychomotor Agitation'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cgommoll@bioxceltherapeutics.com', 'phone': '(475) 355 5177', 'title': 'Vice President Head of Clinical Operations', 'organization': 'BioXcel Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': 'Adverse Events: The Safety Population included all participants in the Randomized Population who received at least 1 dose of double-blind investigational product. One participant enrolled and randomized to the 120 μg group was enrolled a second time at a different site and randomized to the 180 μg group. The data from both enrollments (120 μg and 180 μg) were included in the safety analyses and counted separately in each treatment group; they were counted once when dose groups were combined.', 'eventGroups': [{'id': 'EG000', 'title': '120 Micrograms', 'description': 'Sublingual film containing 120 Micrograms dexmedetomidine\n\nSublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501)', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 51, 'seriousNumAtRisk': 129, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '180 Micrograms', 'description': 'Sublingual film containing 180 Micrograms dexmedetomidine\n\nSublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501)', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 47, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Sublingual placebo film\n\nPlacebo Film: Placebo Film for BXCL501', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 19, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Paresthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 Micrograms', 'description': 'Sublingual film containing 120 Micrograms dexmedetomidine\n\nSublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501)'}, {'id': 'OG001', 'title': '180 Micrograms', 'description': 'Sublingual film containing 180 Micrograms dexmedetomidine\n\nSublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Sublingual placebo film\n\nPlacebo Film: Placebo Film for BXCL501'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '17.5', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '2.69', 'groupId': 'OG001'}, {'value': '17.6', 'spread': '2.26', 'groupId': 'OG002'}]}]}, {'title': '2 Hours', 'categories': [{'measurements': [{'value': '-8.4', 'spread': '4.83', 'groupId': 'OG000'}, {'value': '-10.4', 'spread': '4.34', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '4.69', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 hours', 'description': 'The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population, defined as all participants in the safety population who have a PEC score post-dose.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 Micrograms', 'description': 'Sublingual film containing 120 Micrograms dexmedetomidine\n\nSublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501)'}, {'id': 'OG001', 'title': '180 Micrograms', 'description': 'Sublingual film containing 180 Micrograms dexmedetomidine\n\nSublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Sublingual placebo film\n\nPlacebo Film: Placebo Film for BXCL501'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '17.5', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '2.69', 'groupId': 'OG001'}, {'value': '17.6', 'spread': '2.26', 'groupId': 'OG002'}]}]}, {'title': '10 minutes', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '3.19', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '2.17', 'groupId': 'OG002'}]}]}, {'title': '20 minutes', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '4.03', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '4.54', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '3.20', 'groupId': 'OG002'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '-4.4', 'spread': '4.90', 'groupId': 'OG000'}, {'value': '-5.7', 'spread': '5.27', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '3.56', 'groupId': 'OG002'}]}]}, {'title': '45 minutes', 'categories': [{'measurements': [{'value': '-5.7', 'spread': '5.18', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '5.32', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '3.78', 'groupId': 'OG002'}]}]}, {'title': '60 minutes', 'categories': [{'measurements': [{'value': '-6.9', 'spread': '5.06', 'groupId': 'OG000'}, {'value': '-8.8', 'spread': '4.96', 'groupId': 'OG001'}, {'value': '-4.1', 'spread': '4.16', 'groupId': 'OG002'}]}]}, {'title': '90 minutes', 'categories': [{'measurements': [{'value': '-8.0', 'spread': '5.00', 'groupId': 'OG000'}, {'value': '-9.8', 'spread': '4.60', 'groupId': 'OG001'}, {'value': '-4.6', 'spread': '4.38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': '180 Micrograms versus placebo; 90 minutes post-dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': '120 Micrograms versus placebo; 90 minutes post-dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': '180 Micrograms versus placebo; 60 minutes post-dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': '120 Micrograms versus placebo; 60 minutes post-dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': '180 Micrograms versus placebo; 45 minutes post-dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': '120 Micrograms versus placebo; 45 minutes post-dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': '180 Micrograms versus placebo; 30 minutes post-dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0075', 'groupIds': ['OG000', 'OG002'], 'groupDescription': '120 Micrograms versus placebo; 30 minutes post-dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0032', 'groupIds': ['OG001', 'OG002'], 'groupDescription': '180 Micrograms versus placebo; 20 minutes post-dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4097', 'groupIds': ['OG000', 'OG002'], 'groupDescription': '120 Micrograms versus placebo; 20 minutes post-dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0457', 'groupIds': ['OG001', 'OG002'], 'groupDescription': '180 Micrograms versus placebo; 10 minutes post-dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9720', 'groupIds': ['OG000', 'OG002'], 'groupDescription': '120 Micrograms versus placebo; 10 minutes post-dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 10, 20, 30, 45, 60, 90 minutes post-dose', 'description': 'Effect on agitation onset was measured by change from baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) total score. The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population, defined as all participants in the safety population who have a PEC score post-dose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '120 Micrograms', 'description': 'Sublingual film containing 120 Micrograms dexmedetomidine\n\nSublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501)'}, {'id': 'FG001', 'title': '180 Micrograms', 'description': 'Sublingual film containing 180 Micrograms dexmedetomidine\n\nSublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501)'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Sublingual placebo film\n\nPlacebo Film: Placebo Film for BXCL501'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'comment': 'One participant enrolled in both the 120 microgram treatment group and subsequently the 180 microgram treatment group (at a second site) completed both courses of treatments, but is included only in the 120 microgram group for the randomized population.', 'groupId': 'FG001', 'numSubjects': '125'}, {'groupId': 'FG002', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '123'}, {'groupId': 'FG002', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '380', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '120 Micrograms', 'description': 'Sublingual film containing 120 Micrograms dexmedetomidine\n\nSublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501)'}, {'id': 'BG001', 'title': '180 Micrograms', 'description': 'Sublingual film containing 180 Micrograms dexmedetomidine\n\nSublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501)'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Sublingual placebo film\n\nPlacebo Film: Placebo Film for BXCL501'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '46.0', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '45.1', 'spread': '11.1', 'groupId': 'BG002'}, {'value': '45.6', 'spread': '11.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '241', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '343', '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/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '296', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Positive and Negative Syndrome Scale-Excited Component', 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '17.6', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '17.6', 'spread': '2.3', 'groupId': 'BG002'}, {'value': '17.6', 'spread': '2.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One participant enrolled and randomized to the 120 μg group was enrolled a second time at a different site and randomized to the 180 μg group. The data from the first enrollment and treatment (120 μg) were included in the efficacy analyses. The data from both enrollments (120 μg and 180 μg) were included in the safety analyses and counted separately in each treatment group; they were counted once when dose groups were combined.'}], 'populationDescription': 'Safety population (all participants who received study drug). One participant enrolled and randomized to the 120 μg group was enrolled a second time at a different site and randomized to the 180 μg group. The data from the first enrollment and treatment (120 μg) were included in the efficacy analyses. The data from both enrollments (120 μg and 180 μg) were included in the safety analyses and counted separately for each treatment group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-31', 'size': 6954552, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-25T13:07', 'hasProtocol': True}, {'date': '2020-04-01', 'size': 1170701, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-22T21:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-Blind, Placebo-Controlled'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase III, Randomized, Double-Blind, Placebo-Controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-25', 'studyFirstSubmitDate': '2020-02-11', 'resultsFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2020-02-11', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-25', 'studyFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score', 'timeFrame': 'Baseline and 2 hours', 'description': 'The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time', 'timeFrame': 'Baseline and 10, 20, 30, 45, 60, 90 minutes post-dose', 'description': 'Effect on agitation onset was measured by change from baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) total score. The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Agitation', 'Schizophrenia', 'Schizo Affective Disorder', 'Schizoaffective Disorder', 'Schizophreniform Disorders']}, 'referencesModule': {'references': [{'pmid': '36198061', 'type': 'DERIVED', 'citation': 'Citrome L, Preskorn SH, Lauriello J, Krystal JH, Kakar R, Finman J, De Vivo M, Yocca FD, Risinger R, Rajachandran L. Sublingual Dexmedetomidine for the Treatment of Acute Agitation in Adults With Schizophrenia or Schizoaffective Disorder: A Randomized Placebo-Controlled Trial. J Clin Psychiatry. 2022 Oct 3;83(6):22m14447. doi: 10.4088/JCP.22m14447.'}, {'pmid': '36002761', 'type': 'DERIVED', 'citation': 'Citrome L, Risinger R, Rajachandran L, Robison H. Sublingual Dexmedetomidine for Agitation Associated with Schizophrenia or Bipolar Disorder: A Post Hoc Analysis of Number Needed to Treat, Number Needed to Harm, and Likelihood to be Helped or Harmed. Adv Ther. 2022 Oct;39(10):4821-4835. doi: 10.1007/s12325-022-02274-3. Epub 2022 Aug 24.'}], 'seeAlsoLinks': [{'url': 'https://www.psychiatrist.com/jcp/schizophrenia/sublingual-dexmedetomidine-for-agitation-schizophrenia/', 'label': 'Journal Article'}]}, 'descriptionModule': {'briefSummary': 'This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia. The BXCL501-301 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with schizophrenia, schizoaffective disorder or schizophreniform disorder.', 'detailedDescription': 'The study will enroll approximately 375 subjects randomized 1:1:1 to dose regimens of 180µg, 120µg BXCL501, or placebo. Male and female adults with acute agitation associated with schizophrenia, schizoaffective disorder, or schizophreniform disorder will be enrolled. Eligible subjects may be identified in outpatient clinics, mental health, psychiatric or medical emergency services including medical/psychiatric observation units, or as newly admitted to a hospital setting for acute agitation or already in hospital for chronic underlying conditions. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Efficacy and safety assessments will be conducted periodically before and after dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nA subject will be eligible for inclusion in the study if he or she meets the following criteria:\n\n1. Male and female patients between the ages of 18 to 75 years, inclusive.\n2. Patients who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder.\n3. Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC).\n4. Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.\n5. Patients who read, understand, and provide written informed consent.\n6. Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.\n7. Participants who agree to use a medically acceptable and effective birth control method\n\nExclusion Criteria:\n\nA subject will be excluded from the study if he or she meets the following criteria:\n\n1. Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.\n2. Use of benzodiazepines, hypnotics and anti-psychotic drugs in the 4 hours before study treatment.\n3. Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.\n4. Patients who are judged to be at significant risk of suicide\n5. Female patients who have a positive pregnancy test at screening or are breastfeeding.\n6. Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings.\n7. History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.\n8. Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.\n9. Patients with serious or unstable medical illnesses.\n10. Patients who have received an investigational drug within 30 days prior to the current agitation episode.\n11. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX."}, 'identificationModule': {'nctId': 'NCT04268303', 'acronym': 'SERENITY I', 'briefTitle': 'Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioXcel Therapeutics Inc'}, 'officialTitle': 'A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Determine Efficacy and Safety of BXCL501 In Agitation Associated With Schizophrenia', 'orgStudyIdInfo': {'id': 'BXCL501-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '120 Micrograms', 'description': 'Sublingual film containing 120 Micrograms dexmedetomidine', 'interventionNames': ['Drug: Sublingual film containing dexmedetomidine (BXCL501)']}, {'type': 'EXPERIMENTAL', 'label': '180 Micrograms', 'description': 'Sublingual film containing 180 Micrograms dexmedetomidine', 'interventionNames': ['Drug: Sublingual film containing dexmedetomidine (BXCL501)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Sublingual placebo film', 'interventionNames': ['Drug: Placebo Film']}], 'interventions': [{'name': 'Sublingual film containing dexmedetomidine (BXCL501)', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine'], 'description': 'Sublingual film containing dexmedetomidine (BXCL501)', 'armGroupLabels': ['120 Micrograms', '180 Micrograms']}, {'name': 'Placebo Film', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo Film for BXCL501', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '78754', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '90230', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20877', 'city': 'Gaithersburg', 'state': 'Maryland', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 39.14344, 'lon': -77.20137}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78754', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75115', 'city': 'DeSoto', 'state': 'Texas', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 32.58986, 'lon': -96.85695}}, {'zip': '75080', 'city': 'Richardson', 'state': 'Texas', 'country': 'United States', 'facility': 'BioXcel Clinical Research Site', 'geoPoint': {'lat': 32.94818, 'lon': -96.72972}}], 'overallOfficials': [{'name': 'Robert Risinger, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'BioXcel Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioXcel Therapeutics Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cognitive Research Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}