Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-01-04 @ 5:30 AM
Study NCT ID:
NCT03559257
Status:
COMPLETED
Last Update Posted:
2020-07-08
First Post:
2018-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark', 'Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}], '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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628360', 'term': 'galcanezumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 months', 'description': 'Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 230, 'otherNumAffected': 31, 'seriousNumAtRisk': 230, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of Galcanezumab followed by 120mg Galcanezumab every month for two months by SC injection.', 'otherNumAtRisk': 232, 'deathsNumAtRisk': 232, 'otherNumAffected': 21, 'seriousNumAtRisk': 232, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo/Galcanezumab 120mg - Open-Label Treatment Phase', 'description': 'Participants received initial loading dose of 240mg Galcanezumab followed by 120mg every month for two months by SC injection.', 'otherNumAtRisk': 225, 'deathsNumAtRisk': 225, 'otherNumAffected': 19, 'seriousNumAtRisk': 225, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment', 'description': 'Participants received 120mg of Galcanezumab every month for three months by SC injection.', 'otherNumAtRisk': 224, 'deathsNumAtRisk': 224, 'otherNumAffected': 13, 'seriousNumAtRisk': 224, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 30, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 225, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 224, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 225, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 224, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hemiplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': "Behcet's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg Galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.02', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-4.14', 'spread': '0.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.12', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '-2.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days in Participants With Episodic Migraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-2.88', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.57', 'ciLowerLimit': '-3.41', 'ciUpperLimit': '-1.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.43', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean is derived from the average of months 1 to 3 from MMRM model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥50% Reduction From Baseline in Monthly Migraine Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '17.3'}, {'value': '37.7', 'groupId': 'OG001', 'lowerLimit': '32.9', 'upperLimit': '42.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.935', 'ciLowerLimit': '2.719', 'ciUpperLimit': '5.693', 'statisticalMethod': 'pseudo likelihood-based repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean percentage across months 1 through 3 of patients with at least a 50% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Episodic Migraine With ≥50% Reduction From Baseline in Monthly Migraine Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '22.7'}, {'value': '41.8', 'groupId': 'OG001', 'lowerLimit': '35.7', 'upperLimit': '48.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.481', 'ciLowerLimit': '2.252', 'ciUpperLimit': '5.381', 'statisticalMethod': 'Pseudo likelihood-based repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean percentage across months 1 through 3 of patients with at least a 50% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.68', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '23.21', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.53', 'ciLowerLimit': '9.19', 'ciUpperLimit': '15.87', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.70', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family \\& friends, leisure time, productivity, concentration, energy, tiredness \\& feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);\\&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6),\\& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \\& a positive change in scores reflecting functional improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.\n\nLS Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) in Participants With Episodic Migraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.88', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '23.39', 'spread': '1.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.51', 'ciLowerLimit': '7.14', 'ciUpperLimit': '15.89', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.22', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family \\& friends, leisure time, productivity, concentration, energy, tiredness \\& feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);\\&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6),\\& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \\& a positive change in scores reflecting functional improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized episodic migraine participants who received at least one dose of study drug and had a post baseline value at Month 3. LS Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Episodic Migraine With ≥75% Reduction From Baseline in Monthly Migraine Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '8.2'}, {'value': '18.4', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '23.9'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.878', 'ciLowerLimit': '2.374', 'ciUpperLimit': '14.554', 'statisticalMethod': 'Pseudo likelihood-based repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean percentage across months 1 through 3 of patients with at least a 75% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Episodic Migraine With 100% Reduction From Baseline in Monthly Migraine Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '12.3'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '999.999', 'ciLowerLimit': '548.706', 'ciUpperLimit': '999.999', 'estimateComment': 'Estimated value and upper bound are \\>999.999', 'statisticalMethod': 'Pseudo likelihood-based repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean percentage across months 1 through 3 of patients with 100% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥75% Reduction From Baseline in Monthly Migraine Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '6.3'}, {'value': '14.5', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '19.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.012', 'ciLowerLimit': '2.352', 'ciUpperLimit': '10.679', 'statisticalMethod': 'pseudo likelihood-based repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean percentage across months 1 through 3 of patients with at least a 75% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 100% Reduction From Baseline in Monthly Migraine Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.000'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '8.6'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '999.99', 'ciLowerLimit': '999.99', 'ciUpperLimit': '999.99', 'estimateComment': 'Point estimate, upper limit and lower limit are \\>999.99', 'statisticalMethod': 'Pseudo likelihood-based repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean percentage across months 1 through 3 of patients with 100% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'Overall Mean Change From Baseline in the Number of Monthly Days With Acute Headache Medication Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-4.19', 'spread': '0.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.40', 'ciLowerLimit': '-4.14', 'ciUpperLimit': '-2.65', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'Overall mean is derived from the average of months 1 to 3 from Mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'Overall Mean Change From Baseline in the Number of Monthly Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.05', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-4.18', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.13', 'ciLowerLimit': '-3.96', 'ciUpperLimit': '-2.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'Headache Day: A calendar day on which any type of headache occurred (including migraine, probable migraine, and non-migraine headache).\n\nOverall mean is derived from the average of months 1 to 3 from MMRM model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Migraine Disability Assessment Test (MIDAS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.295', 'spread': '3.2834', 'groupId': 'OG000'}, {'value': '-21.097', 'spread': '3.3164', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missed or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LS mean was calculated using analysis of covariance (ANCOVA) with last observation carried forward (LOCF), with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the 4-item Migraine Interictal Burden Scale (MIBS-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-1.83', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.06', 'ciLowerLimit': '-1.58', 'ciUpperLimit': '-0.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': "MIBS-4 is a self-administered scale that measures the burden related to headache in the time between attacks. The instrument consists of 4 items that address disruption at work and school, diminished family and social life, difficulty planning, and emotional difficulty. The questionnaire specifically asks about the effect of the disease over the past 4 weeks on days without a headache attack. Response options include: don't know/not applicable (0), never (0), rarely (1), some of the time (2), much of the time (3), or most or all of the time (3). Each responses associated numerical score are summed across all 4 items resulting in a total score ranging from 0 to 12, and the level of interictal burden being categorized into the following: 0 for none, 1-2 mild, 3-4 moderate, and \\>5 severe. LS mean was calculated using MMRM model with fixed effects of treatment, pooled country, baseline migraine frequency category, month, treatment by month as fixed effects.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'title': 'Activity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.644', 'spread': '1.9195', 'groupId': 'OG000'}, {'value': '-20.713', 'spread': '1.9537', 'groupId': 'OG001'}]}]}, {'title': 'Absenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.900', 'spread': '1.2436', 'groupId': 'OG000'}, {'value': '-4.224', 'spread': '1.2929', 'groupId': 'OG001'}]}]}, {'title': 'Presenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.564', 'spread': '2.3222', 'groupId': 'OG000'}, {'value': '-12.504', 'spread': '2.3705', 'groupId': 'OG001'}]}]}, {'title': 'Work Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.457', 'spread': '2.4098', 'groupId': 'OG000'}, {'value': '-14.307', 'spread': '2.5148', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Activity Impairment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3880', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Absenteeism.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Presenteeism.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Work impairment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'The WPAI Questionnaire is a patient-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores are calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores are calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes. LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.283', 'spread': '0.0863', 'groupId': 'OG000'}, {'value': '-0.664', 'spread': '0.0873', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'The PGI-S is a patient-rated instrument that measures illness severity. For this study, the patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" The PGI-S includes a range of possible responses, from 1 ("normal, not at all ill") to 7 ("extremely ill"). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (US)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.002', 'spread': '0.0079', 'groupId': 'OG000'}, {'value': '0.013', 'spread': '0.0080', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1267', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': "EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the US algorithm (-0.109 to 1). A higher score indicates better health state. LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (UK)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.0109', 'groupId': 'OG000'}, {'value': '0.017', 'spread': '0.0110', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1630', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': "EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the UK algorithm (-0.594 to 1). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - VAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received matching placebo every month for three months by SC injection.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.086', 'spread': '1.2916', 'groupId': 'OG000'}, {'value': '3.376', 'spread': '1.3080', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0277', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': "EQ-5D-5L is a 2-part questionnaire that assesses general health status 'today'. . The second part is assessed using a visual analog scale (VAS) on which the patient rates their perceived health state, ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/Galcanezumab 120mg', 'description': 'Participants received matching placebo every month for three months by subcutaneous injection (SC) during double blind treatment phase. Participants received initial loading dose of 240mg galcanezumab followed by 120mg every month for two months by SC injection during open label treatment period.'}, {'id': 'FG001', 'title': 'Galcanezumab 120mg', 'description': 'Participants received initial loading dose of 240mg of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection during double blind treatment period. Participants received 120mg of galcanezumab every month for three months by SC injection during open label treatment period.'}], 'periods': [{'title': 'Double Blind Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '233'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '232'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '226'}, {'groupId': 'FG001', 'numSubjects': '225'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open-label Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant who completed double blind period has withdrawn from the study.', 'groupId': 'FG000', 'numSubjects': '225'}, {'comment': 'One participant who completed double blind period had discontinued due to adverse event.', 'groupId': 'FG001', 'numSubjects': '224'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '217'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '462', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo/Galcanezumab 120mg', 'description': 'Participants received matching placebo every month for three months by subcutaneous injection (SC) during double blind treatment phase. Participants received initial loading dose of 240mg galcanezumab followed by 120mg every month for two months by SC injection during open label treatment period.'}, {'id': 'BG001', 'title': 'Galcanezumab 120mg', 'description': 'Participants received initial loading dose of 240mg of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection during double blind treatment period. Participants received 120mg of galcanezumab every month for three months by SC injection during open label treatment period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.67', 'spread': '12.33', 'groupId': 'BG000'}, {'value': '45.87', 'spread': '11.34', 'groupId': 'BG001'}, {'value': '45.77', 'spread': '11.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Monthly Migraine Headache Days', 'classes': [{'categories': [{'measurements': [{'value': '13.01', 'spread': '5.73', 'groupId': 'BG000'}, {'value': '13.44', 'spread': '6.08', 'groupId': 'BG001'}, {'value': '13.23', 'spread': '5.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-22', 'size': 718033, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-09T03:28', 'hasProtocol': True}, {'date': '2019-07-08', 'size': 724689, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-09T03:29', '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': 463}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-19', 'studyFirstSubmitDate': '2018-06-06', 'resultsFirstSubmitDate': '2020-06-19', 'studyFirstSubmitQcDate': '2018-06-06', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-19', 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.'}], 'secondaryOutcomes': [{'measure': 'Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days in Participants With Episodic Migraine', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean is derived from the average of months 1 to 3 from MMRM model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.'}, {'measure': 'Percentage of Participants With ≥50% Reduction From Baseline in Monthly Migraine Headache Days', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean percentage across months 1 through 3 of patients with at least a 50% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.'}, {'measure': 'Percentage of Participants With Episodic Migraine With ≥50% Reduction From Baseline in Monthly Migraine Headache Days', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean percentage across months 1 through 3 of patients with at least a 50% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.'}, {'measure': 'Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)', 'timeFrame': 'Baseline, Month 3', 'description': 'MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family \\& friends, leisure time, productivity, concentration, energy, tiredness \\& feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);\\&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6),\\& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \\& a positive change in scores reflecting functional improvement.'}, {'measure': 'Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) in Participants With Episodic Migraine', 'timeFrame': 'Baseline, Month 3', 'description': 'MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family \\& friends, leisure time, productivity, concentration, energy, tiredness \\& feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);\\&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6),\\& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \\& a positive change in scores reflecting functional improvement.'}, {'measure': 'Percentage of Participants With Episodic Migraine With ≥75% Reduction From Baseline in Monthly Migraine Headache Days', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean percentage across months 1 through 3 of patients with at least a 75% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.'}, {'measure': 'Percentage of Participants With Episodic Migraine With 100% Reduction From Baseline in Monthly Migraine Headache Days', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean percentage across months 1 through 3 of patients with 100% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.'}, {'measure': 'Percentage of Participants With ≥75% Reduction From Baseline in Monthly Migraine Headache Days', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean percentage across months 1 through 3 of patients with at least a 75% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.'}, {'measure': 'Percentage of Participants With 100% Reduction From Baseline in Monthly Migraine Headache Days', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean percentage across months 1 through 3 of patients with 100% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.'}, {'measure': 'Overall Mean Change From Baseline in the Number of Monthly Days With Acute Headache Medication Use', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'Overall mean is derived from the average of months 1 to 3 from Mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.'}, {'measure': 'Overall Mean Change From Baseline in the Number of Monthly Headache Days', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'Headache Day: A calendar day on which any type of headache occurred (including migraine, probable migraine, and non-migraine headache).\n\nOverall mean is derived from the average of months 1 to 3 from MMRM model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.'}, {'measure': 'Mean Change From Baseline in the Migraine Disability Assessment Test (MIDAS) Total Score', 'timeFrame': 'Baseline, Month 3', 'description': 'The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missed or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LS mean was calculated using analysis of covariance (ANCOVA) with last observation carried forward (LOCF), with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.'}, {'measure': 'Mean Change From Baseline in the 4-item Migraine Interictal Burden Scale (MIBS-4)', 'timeFrame': 'Baseline, Month 3', 'description': "MIBS-4 is a self-administered scale that measures the burden related to headache in the time between attacks. The instrument consists of 4 items that address disruption at work and school, diminished family and social life, difficulty planning, and emotional difficulty. The questionnaire specifically asks about the effect of the disease over the past 4 weeks on days without a headache attack. Response options include: don't know/not applicable (0), never (0), rarely (1), some of the time (2), much of the time (3), or most or all of the time (3). Each responses associated numerical score are summed across all 4 items resulting in a total score ranging from 0 to 12, and the level of interictal burden being categorized into the following: 0 for none, 1-2 mild, 3-4 moderate, and \\>5 severe. LS mean was calculated using MMRM model with fixed effects of treatment, pooled country, baseline migraine frequency category, month, treatment by month as fixed effects."}, {'measure': 'Mean Change From Baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI)', 'timeFrame': 'Baseline, Month 3', 'description': 'The WPAI Questionnaire is a patient-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores are calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores are calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes. LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.'}, {'measure': 'Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S)', 'timeFrame': 'Baseline, Month 3', 'description': 'The PGI-S is a patient-rated instrument that measures illness severity. For this study, the patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" The PGI-S includes a range of possible responses, from 1 ("normal, not at all ill") to 7 ("extremely ill"). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.'}, {'measure': 'Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (US)', 'timeFrame': 'Baseline, Month 3', 'description': "EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the US algorithm (-0.109 to 1). A higher score indicates better health state. LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects."}, {'measure': 'Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (UK)', 'timeFrame': 'Baseline, Month 3', 'description': "EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the UK algorithm (-0.594 to 1). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects."}, {'measure': 'Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - VAS Score', 'timeFrame': 'Baseline, Month 3', 'description': "EQ-5D-5L is a 2-part questionnaire that assesses general health status 'today'. . The second part is assessed using a visual analog scale (VAS) on which the patient rates their perceived health state, ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prevention', 'prophylaxis', 'headache', 'treatment-resistant', 'treatment resistant'], 'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '37016181', 'type': 'DERIVED', 'citation': 'Ford JH, Ye W, Ayer DW, Mi X, Bhandari S, Buse DC, Lipton RB. Validation and meaningful within-patient change in work productivity and activity impairment questionnaire (WPAI) for episodic or chronic migraine. J Patient Rep Outcomes. 2023 Apr 4;7(1):34. doi: 10.1186/s41687-023-00552-4.'}, {'pmid': '35930126', 'type': 'DERIVED', 'citation': 'Ailani J, Andrews JS, Tockhorn-Heidenreich A, Wenzel R, Rettiganti M. Effect of Galcanezumab on Total Pain Burden in Patients Who Had Previously Not Benefited from Migraine Preventive Medication (CONQUER Trial): A Post Hoc Analysis. Adv Ther. 2022 Oct;39(10):4544-4555. doi: 10.1007/s12325-022-02233-y. Epub 2022 Aug 5.'}, {'pmid': '35076090', 'type': 'DERIVED', 'citation': 'Ailani J, Kuruppu DK, Rettiganti M, Oakes T, Schroeder K, Wietecha L, Port M, Blumenfeld AM. Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials. Headache. 2022 Feb;62(2):198-207. doi: 10.1111/head.14257. Epub 2022 Jan 25.'}, {'pmid': '35041159', 'type': 'DERIVED', 'citation': 'Tepper SJ, Ailani J, Ford JH, Nichols RM, Li LQ, Kemmer P, Hand AL, Tockhorn-Heidenreich A. Effects of Galcanezumab on Health-Related Quality of Life and Disability in Patients with Previous Failure of 2-4 Migraine Preventive Medication Categories: Results from a Phase IIIb Randomized, Placebo-Controlled, Multicenter Clinical Trial (CONQUER). Clin Drug Investig. 2022 Mar;42(3):263-275. doi: 10.1007/s40261-021-01115-5. Epub 2022 Jan 18.'}, {'pmid': '34592919', 'type': 'DERIVED', 'citation': 'Okonkwo R, Tockhorn-Heidenreich A, Stroud C, Paget MA, Matharu MS, Tassorelli C. Efficacy of galcanezumab in patients with migraine and history of failure to 3-4 preventive medication categories: subgroup analysis from CONQUER study. J Headache Pain. 2021 Sep 30;22(1):113. doi: 10.1186/s10194-021-01322-7.'}, {'pmid': '34542830', 'type': 'DERIVED', 'citation': 'Reuter U, Lucas C, Dolezil D, Hand AL, Port MD, Nichols RM, Stroud C, Tockhorn-Heidenreich A, Detke HC. Galcanezumab in Patients with Multiple Previous Migraine Preventive Medication Category Failures: Results from the Open-Label Period of the CONQUER Trial. Adv Ther. 2021 Nov;38(11):5465-5483. doi: 10.1007/s12325-021-01911-7. Epub 2021 Sep 20.'}, {'pmid': '34264500', 'type': 'DERIVED', 'citation': 'Citrome L, Sanchez Del Rio M, Dong Y, Nichols RM, Tockhorn-Heidenreich A, Foster SA, Stauffer VL. Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm. Adv Ther. 2021 Aug;38(8):4442-4460. doi: 10.1007/s12325-021-01848-x. Epub 2021 Jul 15.'}, {'pmid': '33892641', 'type': 'DERIVED', 'citation': 'Kuruppu DK, Tobin J, Dong Y, Aurora SK, Yunes-Medina L, Green AL. Efficacy of galcanezumab in patients with migraine who did not benefit from commonly prescribed preventive treatments. BMC Neurol. 2021 Apr 23;21(1):175. doi: 10.1186/s12883-021-02196-7.'}, {'pmid': '33765912', 'type': 'DERIVED', 'citation': 'Schwedt TJ, Kuruppu DK, Dong Y, Standley K, Yunes-Medina L, Pearlman E. Early onset of effect following galcanezumab treatment in patients with previous preventive medication failures. J Headache Pain. 2021 Mar 25;22(1):15. doi: 10.1186/s10194-021-01230-w.'}, {'pmid': '32949542', 'type': 'DERIVED', 'citation': 'Mulleners WM, Kim BK, Lainez MJA, Lanteri-Minet M, Pozo-Rosich P, Wang S, Tockhorn-Heidenreich A, Aurora SK, Nichols RM, Yunes-Medina L, Detke HC. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020 Oct;19(10):814-825. doi: 10.1016/S1474-4422(20)30279-9. 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