Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-24 @ 12:25 AM
Study NCT ID:
NCT02828020
Status:
COMPLETED
Last Update Posted:
2019-01-03
First Post:
2016-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], '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': 'C000615620', 'term': 'ubrogepant'}]}}, '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 through 30 days after the last dose of study drug (approximately 30 days)', 'description': 'Safety population, all participants who received at least 1 dose of investigational product was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': '2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.', 'otherNumAtRisk': 485, 'deathsNumAtRisk': 485, 'otherNumAffected': 0, 'seriousNumAtRisk': 485, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ubrogepant 50 mg', 'description': '1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.', 'otherNumAtRisk': 466, 'deathsNumAtRisk': 466, 'otherNumAffected': 0, 'seriousNumAtRisk': 466, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Ubrogepant 100 mg', 'description': '2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.', 'otherNumAtRisk': 485, 'deathsNumAtRisk': 485, 'otherNumAffected': 0, 'seriousNumAtRisk': 485, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 466, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 485, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 20.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 466, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 485, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 20.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 466, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 485, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 20.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 466, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 485, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}, {'value': '448', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG001', 'title': 'Ubrogepant 50 mg', 'description': '1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG002', 'title': 'Ubrogepant 100 mg', 'description': '2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}, {'value': '19.2', 'groupId': 'OG001'}, {'value': '21.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.83', 'ciLowerLimit': '1.25', 'ciUpperLimit': '2.66', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.04', 'ciLowerLimit': '1.41', 'ciUpperLimit': '2.95', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Predose) to 2 hours after initial dose', 'description': 'Pain freedom was defined as a reduction in headache severity from moderate/severe at baseline to no pain at 2 hours after the initial dose. Participants were provided with an electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) population included all randomized participants who received at least 1 dose of study drug, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, last observation carried forward (LOCF).'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}, {'value': '448', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG001', 'title': 'Ubrogepant 50 mg', 'description': '1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG002', 'title': 'Ubrogepant 100 mg', 'description': '2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '38.6', 'groupId': 'OG001'}, {'value': '37.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.70', 'ciLowerLimit': '1.27', 'ciUpperLimit': '2.28', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.'}, {'pValue': '0.0023', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.63', 'ciLowerLimit': '1.22', 'ciUpperLimit': '2.17', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Predose) to 2 hours after initial dose', 'description': "The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}, {'value': '448', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG001', 'title': 'Ubrogepant 50 mg', 'description': '1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG002', 'title': 'Ubrogepant 100 mg', 'description': '2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000'}, {'value': '60.7', 'groupId': 'OG001'}, {'value': '61.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '1.28', 'ciUpperLimit': '2.23', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.'}, {'pValue': '0.0023', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '1.28', 'ciUpperLimit': '2.21', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Predose) to 2 hours after initial dose', 'description': 'Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '434', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG001', 'title': 'Ubrogepant 50 mg', 'description': '1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG002', 'title': 'Ubrogepant 100 mg', 'description': '2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000'}, {'value': '36.3', 'groupId': 'OG001'}, {'value': '38.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.25', 'ciLowerLimit': '1.65', 'ciUpperLimit': '3.07', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.'}, {'pValue': '0.0023', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.39', 'ciLowerLimit': '1.77', 'ciUpperLimit': '3.24', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.'}], 'paramType': 'NUMBER', 'timeFrame': '2 to 24 hours after initial dose', 'description': 'Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with determinable sustained pain relief from 2 to 24 hours after initial dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, determinable cases.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '452', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG001', 'title': 'Ubrogepant 50 mg', 'description': '1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG002', 'title': 'Ubrogepant 100 mg', 'description': '2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}, {'value': '15.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0577', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.57', 'ciLowerLimit': '1.01', 'ciUpperLimit': '2.44', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.'}, {'pValue': '0.0037', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.95', 'ciLowerLimit': '1.28', 'ciUpperLimit': '2.97', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.'}], 'paramType': 'NUMBER', 'timeFrame': '2 to 24 hours after initial dose', 'description': 'Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with determinable sustained pain freedom from 2 to 24 hours after initial dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, determinable cases.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '423', 'groupId': 'OG001'}, {'value': '448', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG001', 'title': 'Ubrogepant 50 mg', 'description': '1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG002', 'title': 'Ubrogepant 100 mg', 'description': '2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000'}, {'value': '40.7', 'groupId': 'OG001'}, {'value': '45.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0577', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.63', 'ciLowerLimit': '1.22', 'ciUpperLimit': '2.19', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.'}, {'pValue': '0.0037', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.81', 'ciLowerLimit': '1.36', 'ciUpperLimit': '2.42', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours after initial dose', 'description': 'Photophobia was defined as sensitivity to light, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence photophobia. Number analyzed is the number of participants with non-missing postdose photophobia assessment at or before 2 hours after initial dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '423', 'groupId': 'OG001'}, {'value': '448', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG001', 'title': 'Ubrogepant 50 mg', 'description': '1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG002', 'title': 'Ubrogepant 100 mg', 'description': '2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000'}, {'value': '57.9', 'groupId': 'OG001'}, {'value': '54.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0577', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '1.16', 'ciUpperLimit': '2.09', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.'}, {'pValue': '0.0577', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.95', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours after initial dose', 'description': 'Phonophobia was defined as sensitivity to sound, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of phonophobia. Number analyzed is the number of participants with non-missing postdose phonophobia assessment at or before 2 hours after initial dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '423', 'groupId': 'OG001'}, {'value': '448', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG001', 'title': 'Ubrogepant 50 mg', 'description': '1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'OG002', 'title': 'Ubrogepant 100 mg', 'description': '2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000'}, {'value': '70.2', 'groupId': 'OG001'}, {'value': '69.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0962', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.79', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.'}, {'pValue': '0.0962', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.83', 'pValueComment': 'P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours after initial dose', 'description': 'Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'FG001', 'title': 'Ubrogepant 50 mg', 'description': '1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'FG002', 'title': 'Ubrogepant 100 mg', 'description': '2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '559'}, {'groupId': 'FG001', 'numSubjects': '556'}, {'groupId': 'FG002', 'numSubjects': '557'}]}, {'type': 'Safety Population: Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '485'}, {'groupId': 'FG001', 'numSubjects': '466'}, {'groupId': 'FG002', 'numSubjects': '485'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '479'}, {'groupId': 'FG001', 'numSubjects': '457'}, {'groupId': 'FG002', 'numSubjects': '479'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '78'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Lack of Qualifying Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Other Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Safety Follow-up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1 participant who did not complete the Treatment Period, was counted in the Safety Follow-up Period.', 'groupId': 'FG000', 'numSubjects': '480'}, {'comment': '1 participant who did not complete the Treatment Period, was counted in the Safety Follow-up Period.', 'groupId': 'FG001', 'numSubjects': '458'}, {'comment': '1 participant who did not complete the Treatment Period, was counted in the Safety Follow-up Period.', 'groupId': 'FG002', 'numSubjects': '480'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '460'}, {'groupId': 'FG001', 'numSubjects': '440'}, {'groupId': 'FG002', 'numSubjects': '461'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '556', 'groupId': 'BG001'}, {'value': '557', 'groupId': 'BG002'}, {'value': '1672', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'BG001', 'title': 'Ubrogepant 50 mg', 'description': '1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'BG002', 'title': 'Ubrogepant 100 mg', 'description': '2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '40.2', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '40.7', 'spread': '12.4', 'groupId': 'BG002'}, {'value': '40.7', 'spread': '12.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '491', 'groupId': 'BG000'}, {'value': '493', 'groupId': 'BG001'}, {'value': '479', 'groupId': 'BG002'}, {'value': '1463', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '209', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '471', 'groupId': 'BG000'}, {'value': '459', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}, {'value': '1377', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian/Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Multiple', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '499', 'groupId': 'BG000'}, {'value': '489', 'groupId': 'BG001'}, {'value': '491', 'groupId': 'BG002'}, {'value': '1479', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) population included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-19', 'size': 4215077, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-12-13T18:07', 'hasProtocol': True}, {'date': '2018-01-22', 'size': 2197195, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-12-13T18:07', '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': 1672}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-13', 'studyFirstSubmitDate': '2016-07-07', 'resultsFirstSubmitDate': '2018-12-13', 'studyFirstSubmitQcDate': '2016-07-07', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-13', 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose', 'timeFrame': 'Baseline (Predose) to 2 hours after initial dose', 'description': 'Pain freedom was defined as a reduction in headache severity from moderate/severe at baseline to no pain at 2 hours after the initial dose. Participants were provided with an electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.'}, {'measure': 'Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose', 'timeFrame': 'Baseline (Predose) to 2 hours after initial dose', 'description': "The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose', 'timeFrame': 'Baseline (Predose) to 2 hours after initial dose', 'description': 'Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.'}, {'measure': 'Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose', 'timeFrame': '2 to 24 hours after initial dose', 'description': 'Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with determinable sustained pain relief from 2 to 24 hours after initial dose.'}, {'measure': 'Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose', 'timeFrame': '2 to 24 hours after initial dose', 'description': 'Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with determinable sustained pain freedom from 2 to 24 hours after initial dose.'}, {'measure': 'Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose', 'timeFrame': '2 hours after initial dose', 'description': 'Photophobia was defined as sensitivity to light, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence photophobia. Number analyzed is the number of participants with non-missing postdose photophobia assessment at or before 2 hours after initial dose.'}, {'measure': 'Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose', 'timeFrame': '2 hours after initial dose', 'description': 'Phonophobia was defined as sensitivity to sound, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of phonophobia. Number analyzed is the number of participants with non-missing postdose phonophobia assessment at or before 2 hours after initial dose.'}, {'measure': 'Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose', 'timeFrame': '2 hours after initial dose', 'description': 'Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine, With or Without Aura']}, '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': '36125279', 'type': 'DERIVED', 'citation': "Johnston KM, Powell L, Popoff E, Harris L, Croop R, Coric V, L'Italien G. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm. Clin J Pain. 2022 Nov 1;38(11):680-685. doi: 10.1097/AJP.0000000000001072."}, {'pmid': '35468729', 'type': 'DERIVED', 'citation': 'Lipton RB, Singh RBH, Revicki DA, Zhao S, Shewale AR, Lateiner JE, Dodick DW. Functionality, satisfaction, and global impression of change with ubrogepant for the acute treatment of migraine in triptan insufficient responders: a post hoc analysis of the ACHIEVE I and ACHIEVE II randomized trials. J Headache Pain. 2022 Apr 25;23(1):50. doi: 10.1186/s10194-022-01419-7.'}, {'pmid': '34874514', 'type': 'DERIVED', 'citation': 'Blumenfeld AM, Knievel K, Manack Adams A, Severt L, Butler M, Lai H, Dodick DW. Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials. Adv Ther. 2022 Jan;39(1):692-705. doi: 10.1007/s12325-021-01923-3. Epub 2021 Dec 7.'}, {'pmid': '33874756', 'type': 'DERIVED', 'citation': 'Hutchinson S, Silberstein SD, Blumenfeld AM, Lipton RB, Lu K, Yu SY, Severt L. Safety and efficacy of ubrogepant in participants with major cardiovascular risk factors in two single-attack phase 3 randomized trials: ACHIEVE I and II. Cephalalgia. 2021 Aug;41(9):979-990. doi: 10.1177/03331024211000311. Epub 2021 Apr 19.'}, {'pmid': '33608814', 'type': 'DERIVED', 'citation': 'Hutchinson S, Dodick DW, Treppendahl C, Bennett NL, Yu SY, Guo H, Trugman JM. Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials. Neurol Ther. 2021 Jun;10(1):235-249. doi: 10.1007/s40120-021-00234-7. Epub 2021 Feb 20.'}, {'pmid': '33241721', 'type': 'DERIVED', 'citation': 'Goadsby PJ, Blumenfeld AM, Lipton RB, Dodick DW, Kalidas K, M Adams A, Jakate A, Liu C, Szegedi A, Trugman JM. Time course of efficacy of ubrogepant for the acute treatment of migraine: Clinical implications. Cephalalgia. 2021 Apr;41(5):546-560. doi: 10.1177/0333102420970523. Epub 2020 Nov 26.'}, {'pmid': '31800988', 'type': 'DERIVED', 'citation': 'Dodick DW, Lipton RB, Ailani J, Lu K, Finnegan M, Trugman JM, Szegedi A. Ubrogepant for the Treatment of Migraine. N Engl J Med. 2019 Dec 5;381(23):2230-2241. doi: 10.1056/NEJMoa1813049.'}], 'seeAlsoLinks': [{'url': 'http://www.allerganclinicaltrials.com', 'label': 'More Information'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50 and 100 mg) compared to placebo for the acute treatment of a single migraine attack.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 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 according to the International Classification of Headache Disorders, 3rd edition, beta version\n* Migraine onset before age 50\n* History of migraines typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom\n* History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the previous 3 months.\n\nExclusion Criteria:\n\n* Difficulty distinguishing migraine headache from other headaches\n* Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs \\[NSAIDs\\], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months\n* Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine\n* Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy\n* Required hospital treatment of a migraine attack 3 or more times in the previous 6 months\n* Has a chronic non-headache pain condition requiring daily pain medication\n* Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer\n* Has a history of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded\n* Has a history of hepatitis within previous 6 months.'}, 'identificationModule': {'nctId': 'NCT02828020', 'acronym': 'ACHIEVE I', 'briefTitle': 'Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine', 'orgStudyIdInfo': {'id': 'UBR-MD-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ubrogepant 50 mg', 'description': '1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.', 'interventionNames': ['Drug: Ubrogepant', 'Drug: Placebo-matching Ubrogepant']}, {'type': 'EXPERIMENTAL', 'label': 'Ubrogepant 100 mg', 'description': '2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.', 'interventionNames': ['Drug: Ubrogepant', 'Drug: Placebo-matching Ubrogepant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. 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