Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-28 @ 5:52 PM
Study NCT ID:
NCT03777059
Status:
COMPLETED
Last Update Posted:
2021-07-09
First Post:
2018-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718987', 'term': 'atogepant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug through end of study (Up to 16 weeks)', 'description': 'All-Cause Mortality is reported for all randomized participants. Safety Population, all participants who received at least 1 dose of study intervention, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo-matching atogepant tablets orally once daily for 12 weeks.', 'otherNumAtRisk': 222, 'deathsNumAtRisk': 223, 'otherNumAffected': 15, 'seriousNumAtRisk': 222, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Atogepant 10 mg', 'description': 'Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.', 'otherNumAtRisk': 221, 'deathsNumAtRisk': 222, 'otherNumAffected': 34, 'seriousNumAtRisk': 221, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Atogepant 30 mg', 'description': 'Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.', 'otherNumAtRisk': 228, 'deathsNumAtRisk': 230, 'otherNumAffected': 37, 'seriousNumAtRisk': 228, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Atogepant 60 mg', 'description': 'Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.', 'otherNumAtRisk': 231, 'deathsNumAtRisk': 235, 'otherNumAffected': 32, 'seriousNumAtRisk': 231, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 22.0'}], 'seriousEvents': [{'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 22.0'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 22.0'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 22.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 22.0'}, {'term': 'Negative pressure pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Atogepant 10 mg', 'description': 'Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Atogepant 30 mg', 'description': 'Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Atogepant 60 mg', 'description': 'Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.48', 'spread': '0.210', 'groupId': 'OG000'}, {'value': '-3.69', 'spread': '0.210', 'groupId': 'OG001'}, {'value': '-3.86', 'spread': '0.206', 'groupId': 'OG002'}, {'value': '-4.20', 'spread': '0.206', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.21', 'ciLowerLimit': '-1.78', 'ciUpperLimit': '-0.64', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.291', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.38', 'ciLowerLimit': '-1.94', 'ciUpperLimit': '-0.82', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.287', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.72', 'ciLowerLimit': '-2.28', 'ciUpperLimit': '-1.15', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.288', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -28 to Day -1) to Week 12', 'description': 'Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. A Mixed-effects model for repeated measures (MMRM) was used for analysis.', 'unitOfMeasure': 'migraine days per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Atogepant 10 mg', 'description': 'Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Atogepant 30 mg', 'description': 'Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Atogepant 60 mg', 'description': 'Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.52', 'spread': '0.225', 'groupId': 'OG000'}, {'value': '-3.94', 'spread': '0.225', 'groupId': 'OG001'}, {'value': '-4.04', 'spread': '0.221', 'groupId': 'OG002'}, {'value': '-4.23', 'spread': '0.221', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.42', 'ciLowerLimit': '-2.03', 'ciUpperLimit': '-0.81', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.311', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.53', 'ciLowerLimit': '-2.13', 'ciUpperLimit': '-0.92', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.307', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.71', 'ciLowerLimit': '-2.32', 'ciUpperLimit': '-1.10', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.309', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day-28 to Day -1) to Week 12', 'description': 'Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration or acute symptomatic medication use. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. MMRM was used for analysis.', 'unitOfMeasure': 'headache days per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Atogepant 10 mg', 'description': 'Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Atogepant 30 mg', 'description': 'Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Atogepant 60 mg', 'description': 'Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.35', 'spread': '0.184', 'groupId': 'OG000'}, {'value': '-3.66', 'spread': '0.183', 'groupId': 'OG001'}, {'value': '-3.68', 'spread': '0.180', 'groupId': 'OG002'}, {'value': '-3.85', 'spread': '0.180', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.31', 'ciLowerLimit': '-1.81', 'ciUpperLimit': '-0.82', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.254', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.33', 'ciLowerLimit': '-1.82', 'ciUpperLimit': '-0.83', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.251', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.50', 'ciLowerLimit': '-2.00', 'ciUpperLimit': '-1.01', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.252', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day-28 to Day -1) to Week 12', 'description': 'Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The monthly (4-week) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of acute medication use days during the last 28 days of the Baseline phase, from Day -28 to -1. A negative change from Baseline indicates improvement. MMRM was used for the analysis.', 'unitOfMeasure': 'acute medication use days per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least a 50% Reduction (Improvement) in 3-month Average of Monthly Migraine Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Atogepant 10 mg', 'description': 'Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Atogepant 30 mg', 'description': 'Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Atogepant 60 mg', 'description': 'Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000'}, {'value': '55.6', 'groupId': 'OG001'}, {'value': '58.7', 'groupId': 'OG002'}, {'value': '60.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.06', 'ciLowerLimit': '2.05', 'ciUpperLimit': '4.56', 'pValueComment': 'Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.53', 'ciLowerLimit': '2.37', 'ciUpperLimit': '5.26', 'pValueComment': 'Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.82', 'ciLowerLimit': '2.56', 'ciUpperLimit': '5.71', 'pValueComment': 'Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day -28 to Day -1) to Week 12', 'description': 'Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. Each 4-week period was averaged.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period (Day -28 to Day -1) of eDiary data, and had at least 1 evaluable post-baseline 4-week period (Weeks 1-4, 5-8, and 9-12) of eDiary data during the Double-blind Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Atogepant 10 mg', 'description': 'Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Atogepant 30 mg', 'description': 'Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Atogepant 60 mg', 'description': 'Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.45', 'spread': '1.617', 'groupId': 'OG000'}, {'value': '30.35', 'spread': '1.639', 'groupId': 'OG001'}, {'value': '30.53', 'spread': '1.593', 'groupId': 'OG002'}, {'value': '31.25', 'spread': '1.591', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.90', 'ciLowerLimit': '5.45', 'ciUpperLimit': '14.36', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.270', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.08', 'ciLowerLimit': '5.71', 'ciUpperLimit': '14.46', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.229', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.80', 'ciLowerLimit': '6.42', 'ciUpperLimit': '15.18', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.231', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': "MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: role function-restrictive (questions 1-7, score range 7 to 42) assesses how migraines limit one's daily social and work-related activities; role function-preventive (questions 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the emotional function (questions 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale where 1=none of the time and 6=all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores from Baseline indicate better quality of life. MMRM was used for the analysis.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Overall number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine-Diary (AIM-D) Across the 12-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Atogepant 10 mg', 'description': 'Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Atogepant 30 mg', 'description': 'Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Atogepant 60 mg', 'description': 'Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.09', 'spread': '0.504', 'groupId': 'OG000'}, {'value': '-7.28', 'spread': '0.500', 'groupId': 'OG001'}, {'value': '-8.63', 'spread': '0.502', 'groupId': 'OG002'}, {'value': '-9.41', 'spread': '0.504', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0856', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.19', 'ciLowerLimit': '-2.56', 'ciUpperLimit': '0.17', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.693', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.54', 'ciLowerLimit': '-3.91', 'ciUpperLimit': '-1.18', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.694', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.32', 'ciLowerLimit': '-4.68', 'ciUpperLimit': '-1.96', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.694', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -28 to Day -1) to Week 12', 'description': 'The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) performance of daily activities domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Overall number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Monthly Physical Impairment Domain Score of the Activity Impairment in Migraine- Diary (AIM-D) Across the 12-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Atogepant 10 mg', 'description': 'Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Atogepant 30 mg', 'description': 'Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Atogepant 60 mg', 'description': 'Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.03', 'spread': '0.439', 'groupId': 'OG000'}, {'value': '-5.11', 'spread': '0.436', 'groupId': 'OG001'}, {'value': '-6.02', 'spread': '0.438', 'groupId': 'OG002'}, {'value': '-6.49', 'spread': '0.439', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0743', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.08', 'ciLowerLimit': '-2.27', 'ciUpperLimit': '0.11', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.605', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.99', 'ciLowerLimit': '-3.18', 'ciUpperLimit': '-0.80', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.606', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.46', 'ciLowerLimit': '-3.65', 'ciUpperLimit': '-1.28', 'pValueComment': 'MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.605', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -28 to Day -1) to Week 12', 'description': 'The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) physical impairment domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Overall number analyzed is the number of participants with data available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'Atogepant 10 mg', 'description': 'Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'FG002', 'title': 'Atogepant 30 mg', 'description': 'Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'FG003', 'title': 'Atogepant 60 mg', 'description': 'Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}], 'periods': [{'title': 'DB Treatment Period (Up to Week 12)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '223'}, {'groupId': 'FG001', 'numSubjects': '222'}, {'groupId': 'FG002', 'numSubjects': '230'}, {'groupId': 'FG003', 'numSubjects': '235'}]}, {'type': 'Treated: Safety Population', 'comment': 'Safety Population included all participants who received at least 1 dose of study intervention.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '221'}, {'groupId': 'FG002', 'numSubjects': '228'}, {'groupId': 'FG003', 'numSubjects': '231'}]}, {'type': 'COMPLETED', 'comment': 'Out of 805 participants who completed DB Treatment Period, 683 participants did not complete follow-up since they rolled into study 3101-309-002 (NCT03939312), 183 entered Follow-Up Period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '193'}, {'groupId': 'FG002', 'numSubjects': '207'}, {'groupId': 'FG003', 'numSubjects': '204'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Follow-Up Period (Weeks 12 to 16)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants diagnosed with episodic migraine were enrolled in one of 4 treatment arms: placebo, or atogepant 10 mg once daily (QD), 30 mg QD, 60 mg QD in Double-blind (DB) Treatment Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}, {'value': '231', 'groupId': 'BG003'}, {'value': '902', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'Atogepant 10 mg', 'description': 'Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Atogepant 30 mg', 'description': 'Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'BG003', 'title': 'Atogepant 60 mg', 'description': 'Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}, {'value': '231', 'groupId': 'BG003'}, {'value': '902', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '40.3', 'spread': '12.81', 'groupId': 'BG000'}, {'value': '41.4', 'spread': '12.05', 'groupId': 'BG001'}, {'value': '42.1', 'spread': '11.68', 'groupId': 'BG002'}, {'value': '42.5', 'spread': '12.41', 'groupId': 'BG003'}, {'value': '41.6', 'spread': '12.25', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}, {'value': '231', 'groupId': 'BG003'}, {'value': '902', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}, {'value': '199', 'groupId': 'BG003'}, {'value': '801', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '101', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}, {'value': '231', 'groupId': 'BG003'}, {'value': '902', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '124', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}, {'value': '752', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}, {'value': '231', 'groupId': 'BG003'}, {'value': '902', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}, {'title': 'Non-Hispanic', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '217', 'groupId': 'BG003'}, {'value': '825', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Monthly Migraine Days', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}, {'value': '873', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '2.39', 'groupId': 'BG000'}, {'value': '7.5', 'spread': '2.46', 'groupId': 'BG001'}, {'value': '7.9', 'spread': '2.32', 'groupId': 'BG002'}, {'value': '7.8', 'spread': '2.31', 'groupId': 'BG003'}, {'value': '7.6', 'spread': '2.37', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged.', 'unitOfMeasure': 'migraine days per month', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.'}, {'title': 'Monthly Headache Days', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}, {'value': '873', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8.4', 'spread': '2.55', 'groupId': 'BG000'}, {'value': '8.4', 'spread': '2.75', 'groupId': 'BG001'}, {'value': '8.8', 'spread': '2.62', 'groupId': 'BG002'}, {'value': '9.0', 'spread': '2.56', 'groupId': 'BG003'}, {'value': '8.7', 'spread': '2.63', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'A headache day is any calendar day on which the participant experienced a headache qualified by duration or acute symptomatic medication use. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged.', 'unitOfMeasure': 'headache days per month', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.'}, {'title': 'Monthly Acute Medication Use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}, {'value': '873', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '3.15', 'groupId': 'BG000'}, {'value': '6.6', 'spread': '2.99', 'groupId': 'BG001'}, {'value': '6.7', 'spread': '3.02', 'groupId': 'BG002'}, {'value': '6.9', 'spread': '3.17', 'groupId': 'BG003'}, {'value': '6.7', 'spread': '3.08', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The monthly (4-week) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged.', 'unitOfMeasure': 'acute medication use days per month', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.'}, {'title': 'MSQ v2.1 Role Function-Restrictive Domain Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}, {'value': '869', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '46.8', 'spread': '19.67', 'groupId': 'BG000'}, {'value': '44.9', 'spread': '21.37', 'groupId': 'BG001'}, {'value': '44.0', 'spread': '19.61', 'groupId': 'BG002'}, {'value': '46.8', 'spread': '20.36', 'groupId': 'BG003'}, {'value': '45.6', 'spread': '20.26', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) is 14-item questionnaire to measure health-related quality-of-life impairments attributed to migraine, divided in 3 domains: role function-restrictive: how migraines limit daily social and work-related activities; role function-preventive: how migraines prevent these activities; and emotional function domain: emotions associated with migraines, using a 6-point scale, 1=none of the time and 6=all of the time. Domain scores were rescaled from 0 to 100, with higher scores indicating better migraine specific quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Number analyzed is the number of participants available for the analyses at Baseline.'}, {'title': 'Daily Activities Domain Score of the Activity Impairment in Migraine- Diary (AIM-D)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}, {'value': '759', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '8.25', 'groupId': 'BG000'}, {'value': '15.5', 'spread': '8.85', 'groupId': 'BG001'}, {'value': '16.9', 'spread': '8.02', 'groupId': 'BG002'}, {'value': '15.9', 'spread': '8.34', 'groupId': 'BG003'}, {'value': '15.9', 'spread': '8.38', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'AIM-D is a 9-item PRO measure that assesses the impact of migraine on performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine. Baseline was defined as the monthly (averaged for a month) scores during the last 28 days.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Number analyzed is the number of participants available for the analyses at Baseline.'}, {'title': 'Monthly Physical Impairment Domain Score of the AIM-D', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}, {'value': '759', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '11.2', 'spread': '8.11', 'groupId': 'BG000'}, {'value': '11.7', 'spread': '8.46', 'groupId': 'BG001'}, {'value': '13.0', 'spread': '8.00', 'groupId': 'BG002'}, {'value': '11.6', 'spread': '7.85', 'groupId': 'BG003'}, {'value': '11.9', 'spread': '8.12', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'AIM-D is a 9-item PRO measure that assesses the impact of migraine on performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine. Baseline was defined as the monthly (averaged for a month) scores during the last 28 days.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Number analyzed is the number of participants available for the analyses at Baseline.'}], 'populationDescription': 'Safety Population included all participants who received at least 1 dose of study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-16', 'size': 1467256, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-18T20:33', 'hasProtocol': True}, {'date': '2020-06-25', 'size': 946005, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-18T20:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 910}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-18', 'studyFirstSubmitDate': '2018-12-13', 'resultsFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2018-12-13', 'lastUpdatePostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-18', 'studyFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period', 'timeFrame': 'Baseline (Day -28 to Day -1) to Week 12', 'description': 'Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. A Mixed-effects model for repeated measures (MMRM) was used for analysis.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period', 'timeFrame': 'Baseline (Day-28 to Day -1) to Week 12', 'description': 'Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration or acute symptomatic medication use. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. MMRM was used for analysis.'}, {'measure': 'Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period', 'timeFrame': 'Baseline (Day-28 to Day -1) to Week 12', 'description': 'Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The monthly (4-week) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of acute medication use days during the last 28 days of the Baseline phase, from Day -28 to -1. A negative change from Baseline indicates improvement. MMRM was used for the analysis.'}, {'measure': 'Percentage of Participants With at Least a 50% Reduction (Improvement) in 3-month Average of Monthly Migraine Days', 'timeFrame': 'Baseline (Day -28 to Day -1) to Week 12', 'description': 'Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. Each 4-week period was averaged.'}, {'measure': 'Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': "MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: role function-restrictive (questions 1-7, score range 7 to 42) assesses how migraines limit one's daily social and work-related activities; role function-preventive (questions 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the emotional function (questions 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale where 1=none of the time and 6=all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores from Baseline indicate better quality of life. MMRM was used for the analysis."}, {'measure': 'Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine-Diary (AIM-D) Across the 12-Week Treatment Period', 'timeFrame': 'Baseline (Day -28 to Day -1) to Week 12', 'description': 'The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) performance of daily activities domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.'}, {'measure': 'Change From Baseline in Mean Monthly Physical Impairment Domain Score of the Activity Impairment in Migraine- Diary (AIM-D) Across the 12-Week Treatment Period', 'timeFrame': 'Baseline (Day -28 to Day -1) to Week 12', 'description': 'The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) physical impairment domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine', 'Aura'], 'conditions': ['Episodic Migraine']}, 'referencesModule': {'references': [{'pmid': '39982105', 'type': 'DERIVED', 'citation': 'Goadsby PJ, Jurgens TP, Brand-Schieber E, Nagy K, Liu Y, Boinpally R, Stodtmann S, Trugman JM. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials. Cephalalgia. 2025 Feb;45(2):3331024251320610. doi: 10.1177/03331024251320610.'}, {'pmid': '39715475', 'type': 'DERIVED', 'citation': 'Lipton RB, Gandhi P, Tassorelli C, Reuter U, Harriott AM, Holle-Lee D, Gottschalk CH, Neel B, Liu Y, Guo H, Stokes J, Nagy K, Dabruzzo B, Smith JH. Early Improvements With Atogepant for the Preventive Treatment of Migraine: Results From 3 Randomized Phase 3 Trials. Neurology. 2025 Jan 28;104(2):e210212. doi: 10.1212/WNL.0000000000210212. Epub 2024 Dec 23.'}, {'pmid': '39648629', 'type': 'DERIVED', 'citation': 'Peterlin BL, Bond DS, Ailani J, Dodick DW, Liu Y, De Abreu Ferreira R, Smith JH, Dabruzzo B, Goadsby PJ, Trugman JM. Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis. Cephalalgia. 2024 Dec;44(12):3331024241299753. doi: 10.1177/03331024241299753.'}, {'pmid': '39648617', 'type': 'DERIVED', 'citation': 'Gottschalk C, Gandhi P, Pozo-Rosich P, Christie S, Tassorelli C, Stokes J, Liu Y, Luo L, Nagy K, Trugman JM, Lipton RB. Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials. Cephalalgia. 2024 Dec;44(12):3331024241300305. doi: 10.1177/03331024241300305.'}, {'pmid': '38773375', 'type': 'DERIVED', 'citation': 'Lipton RB, Nahas SJ, Pozo-Rosich P, Bilchik T, McAllister P, Finnegan M, Liu Y, Chalermpalanupap N, Dabruzzo B, Dodick DW. Sustained response to atogepant in episodic migraine: post hoc analyses of a 12-week randomized trial and a 52-week long-term safety trial. J Headache Pain. 2024 May 21;25(1):83. doi: 10.1186/s10194-024-01783-6.'}, {'pmid': '38462625', 'type': 'DERIVED', 'citation': 'Rizzoli P, Marmura MJ, Robblee J, McVige J, Sacco S, Nahas SJ, Ailani J, De Abreu Ferreira R, Ma J, Smith JH, Dabruzzo B, Ashina M. Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials. J Headache Pain. 2024 Mar 11;25(1):35. doi: 10.1186/s10194-024-01736-z.'}, {'pmid': '36396451', 'type': 'DERIVED', 'citation': 'Lipton RB, Pozo-Rosich P, Blumenfeld AM, Li Y, Severt L, Stokes JT, Creutz L, Gandhi P, Dodick D. Effect of Atogepant for Preventive Migraine Treatment on Patient-Reported Outcomes in the Randomized, Double-blind, Phase 3 ADVANCE Trial. Neurology. 2023 Feb 21;100(8):e764-e777. doi: 10.1212/WNL.0000000000201568. Epub 2022 Nov 17.'}, {'pmid': '35675076', 'type': 'DERIVED', 'citation': 'Lipton RB, Pozo-Rosich P, Blumenfeld AM, Dodick DW, McAllister P, Li Y, Lu K, Dabruzzo B, Miceli R, Severt L, Finnegan M, Trugman JM. Rates of Response to Atogepant for Migraine Prophylaxis Among Adults: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2215499. doi: 10.1001/jamanetworkopen.2022.15499.'}, {'pmid': '34521260', 'type': 'DERIVED', 'citation': 'Schwedt TJ, Lipton RB, Ailani J, Silberstein SD, Tassorelli C, Guo H, Lu K, Dabruzzo B, Miceli R, Severt L, Finnegan M, Trugman JM. Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial. Cephalalgia. 2022 Jan;42(1):3-11. doi: 10.1177/03331024211042385. Epub 2021 Sep 14.'}, {'pmid': '34407343', 'type': 'DERIVED', 'citation': 'Ailani J, Lipton RB, Goadsby PJ, Guo H, Miceli R, Severt L, Finnegan M, Trugman JM; ADVANCE Study Group. Atogepant for the Preventive Treatment of Migraine. N Engl J Med. 2021 Aug 19;385(8):695-706. doi: 10.1056/NEJMoa2035908.'}, {'pmid': '33942560', 'type': 'DERIVED', 'citation': 'Boinpally R, McNamee B, Yao L, Butler M, McGeeney D, Borbridge L, Periclou A. A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1099-1107. doi: 10.1002/cpdd.940. Epub 2021 May 4.'}, {'pmid': '33142014', 'type': 'DERIVED', 'citation': 'Min KC, Kraft WK, Bondiskey P, Colon-Gonzalez F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the prevention of migraine in participants with episodic migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least a 1-year history of migraine with or without aura consistent with a diagnosis.\n* Age of the participant at the time of migraine onset \\<50 years.\n\nExclusion Criteria:\n\n* Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine.\n* Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy.\n* History of an inadequate response to \\>4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine.\n* Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.'}, 'identificationModule': {'nctId': 'NCT03777059', 'briefTitle': '12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine (ADVANCE)', 'orgStudyIdInfo': {'id': '3101-301-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo-matching atogepant tablets orally once daily for 12 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Atogepant 10 mg', 'description': 'Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.', 'interventionNames': ['Drug: Atogepant', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Atogepant 30 mg', 'description': 'Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.', 'interventionNames': ['Drug: Atogepant', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Atogepant 60 mg', 'description': 'Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.', 'interventionNames': ['Drug: Atogepant', 'Drug: Placebo']}], 'interventions': [{'name': 'Atogepant', 'type': 'DRUG', 'description': 'Atogepant tablet', 'armGroupLabels': ['Atogepant 10 mg', 'Atogepant 30 mg', 'Atogepant 60 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo-matching atogepant tablets', 'armGroupLabels': ['Atogepant 10 mg', 'Atogepant 30 mg', 'Atogepant 60 mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Synexus Clinical Research US, Inc.', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Advanced Research Associates', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Alea Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barrow Neurological Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Orange Grove Family Practice', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': 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