Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-22 @ 11:23 AM
Study NCT ID:
NCT02163993
Status:
COMPLETED
Last Update Posted:
2018-11-23
First Post:
2014-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Galcanezumab (LY2951742) in Participants With Migraine Headache
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': 'C000628360', 'term': 'galcanezumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up To 24 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo - Treatment Phase', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.', 'otherNumAtRisk': 137, 'otherNumAffected': 23, 'seriousNumAtRisk': 137, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '5mg Galcanezumab-Treatment Phase', 'description': '5mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.', 'otherNumAtRisk': 68, 'otherNumAffected': 20, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '50mg Galcanezumab-Treatment Phase', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.', 'otherNumAtRisk': 68, 'otherNumAffected': 18, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '120mg Galcanezumab-Treatment Phase', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.', 'otherNumAtRisk': 70, 'otherNumAffected': 23, 'seriousNumAtRisk': 70, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': '300mg Galcanezumab-Treatment Phase', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.', 'otherNumAtRisk': 67, 'otherNumAffected': 19, 'seriousNumAtRisk': 67, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Placebo - Post-Treatment Phase', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.', 'otherNumAtRisk': 125, 'otherNumAffected': 6, 'seriousNumAtRisk': 125, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '5mg Galcanezumab-Post-Treatment Phase', 'description': '5mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.', 'otherNumAtRisk': 61, 'otherNumAffected': 2, 'seriousNumAtRisk': 61, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': '50mg Galcanezumab-Post-Treatment Phase', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.', 'otherNumAtRisk': 66, 'otherNumAffected': 2, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': '120mg Galcanezumab-Post-Treatment Phase', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.', 'otherNumAtRisk': 63, 'otherNumAffected': 2, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': '300mg Galcanezumab-Post-Treatment Phase', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.', 'otherNumAtRisk': 65, 'otherNumAffected': 3, 'seriousNumAtRisk': 65, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 15, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ankyloglossia Congenital', 'notes': 'Following database lock, an additional SAE, ankyloglossia congenital, in a male infant of a paternal pregnancy case, was reported in the Lilly Safety System database (the father was treated with the 300-mg dose of galcanezumab).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG001', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG002', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG003', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG004', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.66', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-4.23', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '-3.92', 'spread': '0.36', 'groupId': 'OG002'}, {'value': '-4.80', 'spread': '0.37', 'groupId': 'OG003'}, {'value': '-4.28', 'spread': '0.39', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-1.40', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.42', 'statisticalMethod': 'Bayesian Dose Response Model', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '0.56', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.41', 'statisticalMethod': 'Bayesian Dose Response Model', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.14', 'ciLowerLimit': '-2.02', 'ciUpperLimit': '-0.29', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.44', 'statisticalMethod': 'Bayesian Dose Response Model', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-1.50', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.45', 'statisticalMethod': 'Bayesian Dose Response Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Number of Migraine Attacks in the Last 28-Day Period of the 12-Week Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG001', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG002', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG003', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG004', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.65', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-2.98', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '-2.87', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '-3.46', 'spread': '0.23', 'groupId': 'OG003'}, {'value': '-3.01', 'spread': '0.23', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria was adapted from the standard IHS ICHD-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least Squares (LS) mean was calculated using mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.', 'unitOfMeasure': 'Migraine attacks', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥50% Reduction in Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG001', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG002', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG003', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG004', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000'}, {'value': '75.4', 'groupId': 'OG001'}, {'value': '65.5', 'groupId': 'OG002'}, {'value': '76.5', 'groupId': 'OG003'}, {'value': '70.1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data during the time period of analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Number of Days of Medication Use for the Treatment of Migraine Headache in the Last 28-Day Period of the 12-Week Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG001', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG002', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG003', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG004', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.51', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-3.27', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '-2.58', 'spread': '0.31', 'groupId': 'OG002'}, {'value': '-3.59', 'spread': '0.31', 'groupId': 'OG003'}, {'value': '-3.15', 'spread': '0.32', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria was adapted from the standard IHS ICHD-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Number of Headache Hours in the Last 28-Day Period of the 12-Week Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG001', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG002', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG003', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG004', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.56', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '-20.15', 'spread': '2.45', 'groupId': 'OG001'}, {'value': '-19.38', 'spread': '2.35', 'groupId': 'OG002'}, {'value': '-22.29', 'spread': '2.39', 'groupId': 'OG003'}, {'value': '-24.45', 'spread': '2.42', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Number of headache hours calculated as the total number of headache hours in a 28-day period on which a headache occurred. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12 Week Endpoint in Migraine Specific Quality of Life (MSQL) Questionnaire Total Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG001', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG002', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG003', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG004', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.08', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '27.53', 'spread': '2.53', 'groupId': 'OG001'}, {'value': '25.35', 'spread': '2.46', 'groupId': 'OG002'}, {'value': '30.23', 'spread': '2.58', 'groupId': 'OG003'}, {'value': '27.49', 'spread': '2.51', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'MSQL consists of 14 questions across 3 dimensions (role function-restrictive, role function-preventive, and emotional function). All question values range from 1 to 6. Participants rated each item from 1 (none of the time) to 6 (all of the time). Since each item was presented as a negative statement, participant responses were recorded before item scores were calculated. Then, dimension scores were calculated as the sum of the recorded items for that specific dimension. Each dimension score was transformed into a score that ranged from 0 to 100. The transformation formula for the restrictive function = \\[(dimension score-7)\\*100\\]/35, for the preventive function = \\[(dimension score-4)\\*100\\]/20, and for the emotional function = \\[(dimension score-3)\\*100\\]/15. A lower score indicated a poorer quality of life associated with that domain. LS means was determined by Analysis of covariance (ANCOVA) with treatment, pooled investigative site and baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and have non-missing values at baseline and post-baseline value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12 Week Endpoint in the Headache Impact Test-6™ (HIT-6™) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG001', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG002', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG003', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG004', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.26', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '-9.26', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '-8.46', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '-9.95', 'spread': '1.12', 'groupId': 'OG003'}, {'value': '-8.27', 'spread': '1.09', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'The HIT-6 consists of 6 questions to measure the impact of headaches on the participants ability to function on the job, at school, at home and in social situations. A score to each question will be assigned as follows: never - 6, rarely - 8, sometimes - 10, very often - 11, and always - 13. The composite score is calculated as the sum of the scores for all 6 questions, the total score ranges between 36 and 78 with higher total scores reflecting more severe impact of headaches. LS means was determined by ANCOVA with treatment, pooled investigative site and baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and have non-missing values at baseline and post-baseline value.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Galcanezumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG001', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG002', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG003', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '840', 'spread': '602', 'groupId': 'OG000'}, {'value': '4650', 'spread': '2430', 'groupId': 'OG001'}, {'value': '13200', 'spread': '7060', 'groupId': 'OG002'}, {'value': '32100', 'spread': '19100', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'Blood serum concentrations of galcanezumab.', 'unitOfMeasure': 'nanomoles per litre (nmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with non-missing baseline and postbaseline measures for serum concentration of galcanezumab.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG001', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG002', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG003', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG004', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1810', 'spread': '0.1030', 'groupId': 'OG000'}, {'value': '0.4750', 'spread': '0.3940', 'groupId': 'OG001'}, {'value': '1.5700', 'spread': '0.7010', 'groupId': 'OG002'}, {'value': '2.8000', 'spread': '1.2200', 'groupId': 'OG003'}, {'value': '3.8300', 'spread': '1.3100', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'CGRP has been shown to be involved in the pathophysiology of migraine through dilation of cerebral and dural blood vessels, release of inflammatory mediators, and transmission of nociceptive (pain) information from intracranial blood vessels to the nervous system (Villalón and Olesen 2009). In migraineurs, serum concentrations of CGRP are significantly elevated during migraine attacks (Goadsby et al. 1990; Goadsby and Edvinsson 1993).', 'unitOfMeasure': 'nanomoles per litre (nmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with non-missing baseline and postbaseline measures for CGRP plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Developing Anti-drug Antibodies to Galcanezumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG001', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG002', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG003', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG004', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}, {'value': '4.6', 'groupId': 'OG002'}, {'value': '2.9', 'groupId': 'OG003'}, {'value': '3.1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 12 Weeks', 'description': 'The percent of participants with treatment emergent Anti-drug Antibodies (ADA) were assessed at week 1 to 12. A participant was considered to have treatment-emergent Galcanezumab ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as any of the following: A negative baseline ADA result and a subsequent positive post-baseline ADA result with a titer \\>=20; or a positive ADA results and a subsequent positive post-baseline ADA results with a 4-fold or greater increase in titer from the baseline measurement.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with non-missing baseline and postbaseline ADA measures.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG001', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG002', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG003', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG004', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}], 'classes': [{'title': 'Suicidal Ideation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1.52', 'groupId': 'OG004'}]}]}, {'title': 'Suicidal Behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 12', 'description': 'The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and with non-missing baseline and postbaseline C-SSRS assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Number of Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG001', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG002', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG003', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG004', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.47', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-2.81', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '-2.57', 'spread': '0.30', 'groupId': 'OG002'}, {'value': '-3.11', 'spread': '0.31', 'groupId': 'OG003'}, {'value': '-3.37', 'spread': '0.31', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Number of calendar days on which a headache lasts ≥4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-3 beta definition. It is defined as headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-3 beta definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Number of Moderate-Severe Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG001', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG002', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG003', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'OG004', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.33', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-2.49', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '-2.33', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '-2.88', 'spread': '0.28', 'groupId': 'OG003'}, {'value': '-3.13', 'spread': '0.28', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Number of calendar days on which headache lasts ≥4 hrs it includes migraines, PM \\& non-migraines. MH is headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-3 beta definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea \\&/or vomiting, or photophobia \\& phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. Severity was measured via interactive voice response system questionnaire "What was the worst headache pain? For mild press 1. For moderate 2. For severe press 3". LSmean was calculated using MMRM with treatment, pooled investigative site, period, treatment-by-period interaction, baseline and baseline-by-period interaction.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'FG001', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'FG002', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'FG003', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'FG004', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '68'}, {'groupId': 'FG003', 'numSubjects': '71'}, {'groupId': 'FG004', 'numSubjects': '69'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '68'}, {'groupId': 'FG003', 'numSubjects': '70'}, {'groupId': 'FG004', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '62'}, {'groupId': 'FG004', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}, {'title': 'Post-treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant discontinued after Treatment Period. Did not enter into Post-treatment Period.', 'groupId': 'FG000', 'numSubjects': '125'}, {'comment': 'Participants who discontinued or completed the Treatment Period entered the Post-treatment period.', 'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'comment': 'Participants who discontinued or completed the Treatment Period entered the Post-treatment period.', 'groupId': 'FG003', 'numSubjects': '63'}, {'comment': 'Participants who discontinued or completed the Treatment Period entered the Post-treatment period.', 'groupId': 'FG004', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '61'}, {'groupId': 'FG004', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Treatment period (0 to 12 weeks), Post-treatment period (12 to 24 weeks)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}, {'value': '410', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'BG001', 'title': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.'}, {'id': 'BG002', 'title': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'BG003', 'title': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'BG004', 'title': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.54', 'spread': '12.10', 'groupId': 'BG000'}, {'value': '41.40', 'spread': '11.15', 'groupId': 'BG001'}, {'value': '39.63', 'spread': '12.42', 'groupId': 'BG002'}, {'value': '40.57', 'spread': '10.92', 'groupId': 'BG003'}, {'value': '40.79', 'spread': '13.20', 'groupId': 'BG004'}, {'value': '40.24', 'spread': '11.96', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}, {'value': '340', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '70', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '343', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '75', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '307', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}, {'value': '410', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Number of migraine headache days', 'classes': [{'categories': [{'measurements': [{'value': '6.64', 'spread': '2.73', 'groupId': 'BG000'}, {'value': '6.68', 'spread': '2.73', 'groupId': 'BG001'}, {'value': '6.41', 'spread': '2.66', 'groupId': 'BG002'}, {'value': '6.95', 'spread': '2.56', 'groupId': 'BG003'}, {'value': '6.73', 'spread': '2.48', 'groupId': 'BG004'}, {'value': '6.68', 'spread': '2.64', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Migraine Headache Day: A calendar day on which a migraine headache occurred.', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of probable and migraine headache days', 'classes': [{'categories': [{'measurements': [{'value': '8.04', 'spread': '3.08', 'groupId': 'BG000'}, {'value': '8.55', 'spread': '3.23', 'groupId': 'BG001'}, {'value': '8.33', 'spread': '3.21', 'groupId': 'BG002'}, {'value': '8.69', 'spread': '3.46', 'groupId': 'BG003'}, {'value': '8.01', 'spread': '2.79', 'groupId': 'BG004'}, {'value': '8.28', 'spread': '3.15', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Probable Migraine Headache Day: A calendar day on which a probable migraine headache occurred.', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 414}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'dispFirstSubmitDate': '2016-08-12', 'completionDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-20', 'studyFirstSubmitDate': '2014-06-12', 'dispFirstSubmitQcDate': '2016-08-12', 'resultsFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2014-06-13', 'dispFirstPostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-20', 'studyFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Number of Migraine Attacks in the Last 28-Day Period of the 12-Week Treatment Phase', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria was adapted from the standard IHS ICHD-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least Squares (LS) mean was calculated using mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.'}, {'measure': 'Percentage of Participants With ≥50% Reduction in Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase', 'timeFrame': 'Week 12', 'description': 'The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.'}, {'measure': 'Mean Change From Baseline in the Number of Days of Medication Use for the Treatment of Migraine Headache in the Last 28-Day Period of the 12-Week Treatment Phase', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria was adapted from the standard IHS ICHD-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.'}, {'measure': 'Mean Change From Baseline in Number of Headache Hours in the Last 28-Day Period of the 12-Week Treatment Phase', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Number of headache hours calculated as the total number of headache hours in a 28-day period on which a headache occurred. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.'}, {'measure': 'Change From Baseline to 12 Week Endpoint in Migraine Specific Quality of Life (MSQL) Questionnaire Total Scores', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'MSQL consists of 14 questions across 3 dimensions (role function-restrictive, role function-preventive, and emotional function). All question values range from 1 to 6. Participants rated each item from 1 (none of the time) to 6 (all of the time). Since each item was presented as a negative statement, participant responses were recorded before item scores were calculated. Then, dimension scores were calculated as the sum of the recorded items for that specific dimension. Each dimension score was transformed into a score that ranged from 0 to 100. The transformation formula for the restrictive function = \\[(dimension score-7)\\*100\\]/35, for the preventive function = \\[(dimension score-4)\\*100\\]/20, and for the emotional function = \\[(dimension score-3)\\*100\\]/15. A lower score indicated a poorer quality of life associated with that domain. LS means was determined by Analysis of covariance (ANCOVA) with treatment, pooled investigative site and baseline.'}, {'measure': 'Change From Baseline to 12 Week Endpoint in the Headache Impact Test-6™ (HIT-6™) Scores', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'The HIT-6 consists of 6 questions to measure the impact of headaches on the participants ability to function on the job, at school, at home and in social situations. A score to each question will be assigned as follows: never - 6, rarely - 8, sometimes - 10, very often - 11, and always - 13. The composite score is calculated as the sum of the scores for all 6 questions, the total score ranges between 36 and 78 with higher total scores reflecting more severe impact of headaches. LS means was determined by ANCOVA with treatment, pooled investigative site and baseline.'}, {'measure': 'Serum Concentration of Galcanezumab', 'timeFrame': '12 Weeks', 'description': 'Blood serum concentrations of galcanezumab.'}, {'measure': 'Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)', 'timeFrame': '12 Weeks', 'description': 'CGRP has been shown to be involved in the pathophysiology of migraine through dilation of cerebral and dural blood vessels, release of inflammatory mediators, and transmission of nociceptive (pain) information from intracranial blood vessels to the nervous system (Villalón and Olesen 2009). In migraineurs, serum concentrations of CGRP are significantly elevated during migraine attacks (Goadsby et al. 1990; Goadsby and Edvinsson 1993).'}, {'measure': 'Percentage of Participants Developing Anti-drug Antibodies to Galcanezumab', 'timeFrame': 'Baseline through 12 Weeks', 'description': 'The percent of participants with treatment emergent Anti-drug Antibodies (ADA) were assessed at week 1 to 12. A participant was considered to have treatment-emergent Galcanezumab ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as any of the following: A negative baseline ADA result and a subsequent positive post-baseline ADA result with a titer \\>=20; or a positive ADA results and a subsequent positive post-baseline ADA results with a 4-fold or greater increase in titer from the baseline measurement.'}, {'measure': 'Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores', 'timeFrame': 'Baseline through Week 12', 'description': 'The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.'}, {'measure': 'Mean Change From Baseline in the Number of Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Number of calendar days on which a headache lasts ≥4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-3 beta definition. It is defined as headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-3 beta definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.'}, {'measure': 'Mean Change From Baseline in the Number of Moderate-Severe Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Number of calendar days on which headache lasts ≥4 hrs it includes migraines, PM \\& non-migraines. MH is headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-3 beta definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea \\&/or vomiting, or photophobia \\& phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. Severity was measured via interactive voice response system questionnaire "What was the worst headache pain? For mild press 1. For moderate 2. For severe press 3". LSmean was calculated using MMRM with treatment, pooled investigative site, period, treatment-by-period interaction, baseline and baseline-by-period interaction.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Migraine Headache']}, 'referencesModule': {'references': [{'pmid': '32576229', 'type': 'DERIVED', 'citation': 'Stauffer VL, Turner I, Kemmer P, Kielbasa W, Day K, Port M, Quinlan T, Camporeale A. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. J Headache Pain. 2020 Jun 23;21(1):79. doi: 10.1186/s10194-020-01148-9.'}, {'pmid': '31952501', 'type': 'DERIVED', 'citation': 'Bangs ME, Kudrow D, Wang S, Oakes TM, Terwindt GM, Magis D, Yunes-Medina L, Stauffer VL. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020 Jan 17;20(1):25. doi: 10.1186/s12883-020-1609-7.'}, {'pmid': '31482569', 'type': 'DERIVED', 'citation': 'Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.'}, {'pmid': '29255900', 'type': 'DERIVED', 'citation': 'Skljarevski V, Oakes TM, Zhang Q, Ferguson MB, Martinez J, Camporeale A, Johnson KW, Shan Q, Carter J, Schacht A, Goadsby PJ, Dodick DW. Effect of Different Doses of Galcanezumab vs Placebo for Episodic Migraine Prevention: A Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):187-193. doi: 10.1001/jamaneurol.2017.3859.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate whether the study drug known as galcanezumab is safe and effective in the prevention of migraine headaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with a history of migraine of at least 1 year prior to enrollment.\n* Migraine onset prior to age 50.\n\nExclusion Criteria:\n\n* Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.\n* Current use or any prior exposure to any CGRP antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).\n* History of migraine subtypes including hemiplegic migraine, ophthalmoplegic migraine, and basilar-type migraine.\n* Have a history or presence of other medical illness that indicates a medical problem that would preclude study participation.\n* Failure to respond to more than two adequately dosed effective migraine prevention treatments.\n* Evidence of significant active psychiatric disease, in the opinion of the investigator.\n* Women who are pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT02163993', 'briefTitle': 'A Study of Galcanezumab (LY2951742) in Participants With Migraine Headache', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients With Episodic Migraine', 'orgStudyIdInfo': {'id': '15414'}, 'secondaryIdInfos': [{'id': 'I5Q-MC-CGAB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5mg Galcanezumab', 'description': '5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.', 'interventionNames': ['Drug: Galcanezumab']}, {'type': 'EXPERIMENTAL', 'label': '50mg Galcanezumab', 'description': '50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.', 'interventionNames': ['Drug: Galcanezumab']}, {'type': 'EXPERIMENTAL', 'label': '120mg Galcanezumab', 'description': '120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.', 'interventionNames': ['Drug: Galcanezumab']}, {'type': 'EXPERIMENTAL', 'label': '300mg Galcanezumab', 'description': '300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.', 'interventionNames': ['Drug: Galcanezumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo given as SQ injections once every 28 days during a 12 week treatment period.', 'interventionNames': ['Drug: Placebo']}], 'interventions': 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