Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT04073303
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2019-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742', 'title': 'ABBVIE CALL CENTER', 'organization': 'AbbVie'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo was administered as bilateral intramuscular injections into the masseter on Day 1', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 19, 'seriousNumAtRisk': 93, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'BOTOX®', 'description': 'BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments', 'otherNumAtRisk': 283, 'deathsNumAtRisk': 283, 'otherNumAffected': 54, 'seriousNumAtRisk': 283, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'MASTICATION DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'VENTRICULAR EXTRASYSTOLES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HAEMORRHOIDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'GALLBLADDER POLYP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'POST-ACUTE COVID-19 SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PULMONARY TUBERCULOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'POST HERPETIC NEURALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ABORTION OF ECTOPIC PREGNANCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ABORTION THREATENED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'FOETAL GROWTH RESTRICTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ENDOMETRIOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'FALLOPIAN TUBE CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'LUNG OPACITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'NASAL SEPTUM DEVIATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ABORTION INDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered as bilateral intramuscular injections into the masseter on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX®', 'description': 'BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.2'}, {'value': '51.2', 'groupId': 'OG001', 'lowerLimit': '45.2', 'upperLimit': '57.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate-Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.0', 'ciLowerLimit': '40.1', 'ciUpperLimit': '54.1', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90', 'description': 'Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS).\n\nMMPS ranges from 1 = minimal to 5 = very marked.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Achievement of MMPS Grade ≤ 3 at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered as bilateral intramuscular injections into the masseter on Day 1'}, {'id': 'OG001', 'title': 'BOTOX®', 'description': 'BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '16.1'}, {'value': '81.1', 'groupId': 'OG001', 'lowerLimit': '76.4', 'upperLimit': '85.9'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate-Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.2', 'ciLowerLimit': '60.7', 'ciUpperLimit': '76.3', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90', 'description': 'Proportion of participants who achieve MMPS Grade of ≤ 3 at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS).\n\nMMPS ranges from 1 = minimal to 5 = very marked.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Achievement of MMPS-P Grade ≤ 3 on Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered as bilateral intramuscular injections into the masseter on Day 1'}, {'id': 'OG001', 'title': 'BOTOX®', 'description': 'BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '11.2', 'upperLimit': '27.8'}, {'value': '76.2', 'groupId': 'OG001', 'lowerLimit': '71.1', 'upperLimit': '81.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate-Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '56.7', 'ciLowerLimit': '45.6', 'ciUpperLimit': '64.5', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90', 'description': 'Proportion of participants who achieve MMPS-P Grade ≤ 3 at Day 90, according to participant, per Masseter Muscle Prominence Scale-Participant (MMPS-P)\n\nMMPS-P ranges from 1 = not at all pronounced to 5 = very pronounced.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered as bilateral intramuscular injections into the masseter on Day 1'}, {'id': 'OG001', 'title': 'BOTOX®', 'description': 'BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '15.0'}, {'value': '58.8', 'groupId': 'OG001', 'lowerLimit': '52.9', 'upperLimit': '64.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate-Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.7', 'ciLowerLimit': '40.6', 'ciUpperLimit': '57.4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90', 'description': 'Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per Masseter Muscle Prominence Scale-Participant (MMPS-P)\n\nMMPS-P ranges from 1 = not at all pronounced to 5 = very pronounced.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered as bilateral intramuscular injections into the masseter on Day 1'}, {'id': 'OG001', 'title': 'BOTOX®', 'description': 'BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments'}], 'classes': [{'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '28.7'}, {'value': '90.8', 'groupId': 'OG001', 'lowerLimit': '87.3', 'upperLimit': '94.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate-Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '70.5', 'ciLowerLimit': '59.6', 'ciUpperLimit': '77.5', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90', 'description': 'Proportion of participants who achieve Grade ≥ 1 on Participant Self-Assessment of Change (PSAC) (at least minimally improved from baseline) at Day 90\n\nPSAC ranges from 3 = much improved to -3 = much worse.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lower Facial Width (mm) at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered as bilateral intramuscular injections into the masseter on Day 1'}, {'id': 'OG001', 'title': 'BOTOX®', 'description': 'BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '-5.24', 'spread': '0.121', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.19', 'ciLowerLimit': '-5.64', 'ciUpperLimit': '-4.75', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 90', 'description': 'Calculated from standardized images, measured in millimeters (mm)', 'unitOfMeasure': 'millimeters (mm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Median Duration of Effect for MMPS Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BOTOX®', 'description': 'BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments'}], 'classes': [{'title': 'MMPS ≥ 2-Grade Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '176.0', 'groupId': 'OG000', 'lowerLimit': '154.0', 'upperLimit': '183.0'}]}]}, {'title': 'MMPS Grade ≤ 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '213.0', 'groupId': 'OG000', 'lowerLimit': '204.0', 'upperLimit': '236.0'}]}]}, {'title': 'MMPS ≥ 1-Grade Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '268.0', 'groupId': 'OG000', 'lowerLimit': '239.0', 'upperLimit': '304.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 360', 'description': 'Median duration of effect for BOTOX-treated MMPS responders.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo was administered as bilateral intramuscular injections into the masseter on Day 1.'}, {'id': 'FG001', 'title': 'BOTOX®', 'description': 'BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '284'}]}, {'type': 'mITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '278'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '240'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 377 participants were enrolled and randomized into the study; 284 to BOTOX and 93 to Placebo. A total of 370 participants were included in the modified ITT (mITT) Population; 278 to BOTOX and 92 to Placebo. A participant was considered to have completed the study if he/she had at least completed the treatment visit and the end of study visit.', 'preAssignmentDetails': 'The mITT population, consisting of all randomized subjects with at least 1 postbaseline MMPS assessment, comprised 370 subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo was administered as bilateral intramuscular injections into the masseter on Day 1'}, {'id': 'BG001', 'title': 'BOTOX®', 'description': 'BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.0', 'spread': '8.67', 'groupId': 'BG000'}, {'value': '31.5', 'spread': '8.35', 'groupId': 'BG001'}, {'value': '31.4', 'spread': '8.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '247', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Masseter Muscle Prominence Scale (MMPS)', 'classes': [{'title': '4 = Marked', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}]}, {'title': '5 = Very Marked', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The investigator assessed the severity of the participant's masseter muscle prominence (MMP) using the MMPS 5-point scale ranging from 1=minimal to 5=very marked. Higher scores represent more severe outcomes.", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified Intent-to-Treat (mITT) Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-17', 'size': 8107429, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-24T11:34', 'hasProtocol': True}, {'date': '2022-12-20', 'size': 1935369, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-24T11:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 377}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'dispFirstSubmitDate': '2023-10-10', 'completionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2019-08-22', 'resultsFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2019-08-27', 'dispFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-18', 'studyFirstPostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90', 'timeFrame': 'Day 90', 'description': 'Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS).\n\nMMPS ranges from 1 = minimal to 5 = very marked.'}], 'secondaryOutcomes': [{'measure': 'Achievement of MMPS Grade ≤ 3 at Day 90', 'timeFrame': 'Day 90', 'description': 'Proportion of participants who achieve MMPS Grade of ≤ 3 at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS).\n\nMMPS ranges from 1 = minimal to 5 = very marked.'}, {'measure': 'Achievement of MMPS-P Grade ≤ 3 on Day 90', 'timeFrame': 'Day 90', 'description': 'Proportion of participants who achieve MMPS-P Grade ≤ 3 at Day 90, according to participant, per Masseter Muscle Prominence Scale-Participant (MMPS-P)\n\nMMPS-P ranges from 1 = not at all pronounced to 5 = very pronounced.'}, {'measure': 'Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at Day 90', 'timeFrame': 'Day 90', 'description': 'Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per Masseter Muscle Prominence Scale-Participant (MMPS-P)\n\nMMPS-P ranges from 1 = not at all pronounced to 5 = very pronounced.'}, {'measure': 'Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on Day 90', 'timeFrame': 'Day 90', 'description': 'Proportion of participants who achieve Grade ≥ 1 on Participant Self-Assessment of Change (PSAC) (at least minimally improved from baseline) at Day 90\n\nPSAC ranges from 3 = much improved to -3 = much worse.'}, {'measure': 'Change From Baseline in Lower Facial Width (mm) at Day 90', 'timeFrame': 'Day 90', 'description': 'Calculated from standardized images, measured in millimeters (mm)'}, {'measure': 'Median Duration of Effect for MMPS Responders', 'timeFrame': 'Up to Day 360', 'description': 'Median duration of effect for BOTOX-treated MMPS responders.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Masseter Muscle Prominence']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria:\n\n* Masseter prominence at the Day 1 visit\n* BMI ≤ 30 kg/m2 using the calculation: BMI = weight (kg)/\\[height (m)\\]2\n* A female participant must be willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up periods\n\nExclusion Criteria:\n\n* Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function\n* An anticipated need for surgery or overnight hospitalization during the study\n* An anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)\n* History of dental or surgical procedure for lower facial shaping or masseter muscle reduction\n* Prior mid-facial and/or lower facial treatment with nonpermanent soft tissue fillers, synthetic implantations, autologous fat transplantation, fat-reducing injectables, and/or skin-tightening laser treatments within 6 months prior to Day 1\n* Prior exposure to botulinum toxin of any serotype to the masseter muscle or lower face at any time, or to any other part of the body within the 6 months prior to Day 1\n* History of temporomandibular joint disorder (TMJD)\n* Masseter prominence due to other etiologies (eg, parotid gland infection, parotiditis, malignancy)\n* Known allergy or sensitivity to any of the components of the study treatments or any materials used in the study procedures\n* History of alcohol or drug abuse within 12 months of Day 1'}, 'identificationModule': {'nctId': 'NCT04073303', 'briefTitle': 'BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study', 'orgStudyIdInfo': {'id': '1789-301-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Botulinum Toxin Type A (BOTOX®)', 'description': 'Botulinum Toxin Type A (BOTOX ®) will be administered on Day 1 as bilateral intramuscular injections into the masseter with the possibility of 2 additional treatments', 'interventionNames': ['Biological: Botulinum Toxin Type A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (normal saline) will be administered on Day 1 as bilateral intramuscular injections into the masseter', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Botulinum Toxin Type A', 'type': 'BIOLOGICAL', 'otherNames': ['OnabotulinumtoxinA', 'BOTOX®'], 'description': 'Day 1 Administration of bilateral intramuscular injections into the masseter', 'armGroupLabels': ['Botulinum Toxin Type A (BOTOX®)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Day 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3E 0B2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Duplicate_Beacon Dermatology Inc /ID# 233018', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V5Z 4E1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Duplicate_Humphrey Cosmetic Dermatology /ID# 232764', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6H 1K9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Project Skin MD LTD /ID# 232763', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6H 4E1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pacific Derm /ID# 233156', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L4B 1A5', 'city': 'Richmond Hill', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Center For Dermatology /ID# 233001', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital /ID# 233148', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Duplicate_Peking Union Medical College Hospital /ID# 233072', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese PLA General Hospital /ID# 233158', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100034', 'city': 'Xicheng District', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital /ID# 232973'}, {'zip': '300052', 'city': 'Tianjin', 'state': 'Guizhou', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital /ID# 232961'}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233008', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Xiangya Hospital Central South University /ID# 233027', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital /ID# 233016', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda Hospital Southeast University /ID# 232836', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200011', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 232656", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '710038', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 233087', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital, Sichuan University /ID# 233107', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '807', 'city': 'Kaohsiung City', 'state': 'Keelung', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 233033', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '100', 'city': 'Taipei City', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital /ID# 233133'}, {'zip': '11031', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University Hospital /ID# 233009', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11490', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital /ID# 233080', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'ALLERGAN INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}