Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-02-23 @ 10:36 PM
Study NCT ID:
NCT02559895
Status:
COMPLETED
Last Update Posted:
2020-05-14
First Post:
2015-09-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multicenter Assessment of ALD403 in Frequent Episodic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628361', 'term': 'eptinezumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LundbeckClinicalTrials@Lundbeck.com', 'phone': '+4536301311', 'title': 'Email contact via', 'organization': 'H. Lundbeck A/S'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline to Week 56 (end of study)', 'description': '2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.', 'eventGroups': [{'id': 'EG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).', 'otherNumAtRisk': 224, 'deathsNumAtRisk': 224, 'otherNumAffected': 44, 'seriousNumAtRisk': 224, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).', 'otherNumAtRisk': 223, 'deathsNumAtRisk': 223, 'otherNumAffected': 44, 'seriousNumAtRisk': 223, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).', 'otherNumAtRisk': 219, 'deathsNumAtRisk': 219, 'otherNumAffected': 44, 'seriousNumAtRisk': 219, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).', 'otherNumAtRisk': 222, 'deathsNumAtRisk': 222, 'otherNumAffected': 41, 'seriousNumAtRisk': 222, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hepatic Cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Postprocedural Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Stomal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Benign Breast Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Breast Cancer Stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Panic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Uterine Prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Postprocedural Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Monthly Migraine Days (Weeks 1-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.3', 'spread': '3.42', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '3.23', 'groupId': 'OG001'}, {'value': '-4.1', 'spread': '3.22', 'groupId': 'OG002'}, {'value': '-3.1', 'spread': '3.70', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.11', 'ciLowerLimit': '-1.68', 'ciUpperLimit': '-0.54', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.40', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0182', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '-0.12', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.40', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0046', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-1.39', 'ciUpperLimit': '-0.25', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.40', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 1-12', 'description': 'Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12', 'unitOfMeasure': 'Migraine Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': '75% Migraine Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.5', 'ciLowerLimit': '5.8', 'ciUpperLimit': '21.2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1126', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.0', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '13.3', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0272', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.4', 'ciLowerLimit': '1.0', 'ciUpperLimit': '15.9', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1-12', 'description': 'Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': '75% Migraine Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0066', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.3', 'ciLowerLimit': '3.2', 'ciUpperLimit': '19.3', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0112', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.5', 'ciLowerLimit': '2.4', 'ciUpperLimit': '18.6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0170', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.8', 'ciLowerLimit': '1.8', 'ciUpperLimit': '17.8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1-4', 'description': 'Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': '50% Migraine Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.9', 'ciLowerLimit': '9.8', 'ciUpperLimit': '28.0', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0085', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.4', 'ciLowerLimit': '3.2', 'ciUpperLimit': '21.5', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0064', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.8', 'ciLowerLimit': '3.7', 'ciUpperLimit': '22.0', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1-12', 'description': 'Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Migraine on the Day After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '14.8', 'groupId': 'OG001'}, {'value': '17.3', 'groupId': 'OG002'}, {'value': '22.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0159', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0312', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1539', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'The percentage of participants with a migraine on the day after dosing, where Day 0 is treatment day and Day 1 is the day after dosing', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': '75% Headache Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1-12', 'description': 'Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': '50% Headache Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1-12', 'description': 'Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': '100% Migraine Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1-12', 'description': 'Participants with a reduction in migraine days of 100% over Weeks 1 to 12, as compared with baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': '100% Headache Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1-12', 'description': 'Participants with a reduction in headache days of 100% over Weeks 1 to 12, as compared with baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Acute Migraine Medication Days (Weeks 1-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '2.00', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '1.62', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '1.27', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1-12', 'description': 'The change in number of days with any triptan or ergotamine use as recorded in the eDiary.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average Daily Migraine Prevalence to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.9', 'spread': '19.78', 'groupId': 'OG000'}, {'value': '-13.8', 'spread': '19.27', 'groupId': 'OG001'}, {'value': '-15.1', 'spread': '17.83', 'groupId': 'OG002'}, {'value': '-9.7', 'spread': '19.33', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 4', 'description': 'The change in the percentage of days where a participant has a migraine from baseline to Week 4.', 'unitOfMeasure': 'percentage of days with migraine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '62.08', 'spread': '38.46', 'groupId': 'OG000'}, {'value': '66.58', 'spread': '34.13', 'groupId': 'OG001'}, {'value': '69.11', 'spread': '33.72', 'groupId': 'OG002'}, {'value': '71.44', 'spread': '34.59', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1-12', 'description': 'The percentage of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.', 'unitOfMeasure': 'percentage of acute medication migraines', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '63.09', 'spread': '36.87', 'groupId': 'OG000'}, {'value': '66.85', 'spread': '33.65', 'groupId': 'OG001'}, {'value': '67.84', 'spread': '33.59', 'groupId': 'OG002'}, {'value': '70.95', 'spread': '33.43', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1-12', 'description': 'The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.', 'unitOfMeasure': 'percentage of acute medication headaches', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Monthly Headache Days (Weeks 1-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.5', 'spread': '3.96', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '3.30', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '3.24', 'groupId': 'OG002'}, {'value': '-3.3', 'spread': '3.51', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1-12', 'description': 'Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.', 'unitOfMeasure': 'headache days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': 'Percent of Headaches With Severe Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '17.06', 'spread': '22.03', 'groupId': 'OG000'}, {'value': '19.84', 'spread': '24.83', 'groupId': 'OG001'}, {'value': '21.20', 'spread': '26.60', 'groupId': 'OG002'}, {'value': '21.68', 'spread': '22.67', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1-12', 'description': 'Summary of percent of headaches with severe intensity over Weeks 1-12.', 'unitOfMeasure': 'percentage of severe intensity headaches', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': 'Percent of Migraines With Severe Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '19.07', 'spread': '23.46', 'groupId': 'OG000'}, {'value': '22.23', 'spread': '26.30', 'groupId': 'OG001'}, {'value': '24.43', 'spread': '28.15', 'groupId': 'OG002'}, {'value': '26.01', 'spread': '24.99', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1-12', 'description': 'Summary of percent of migraines with severe intensity over Week 1-12.', 'unitOfMeasure': 'percentage of severe intensity migraines', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Monthly Migraine Hours (Weeks 1-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.9', 'spread': '49.91', 'groupId': 'OG000'}, {'value': '-35.3', 'spread': '47.85', 'groupId': 'OG001'}, {'value': '-37.8', 'spread': '50.17', 'groupId': 'OG002'}, {'value': '-23.8', 'spread': '50.91', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1-12', 'description': 'Migraine hours are the sum of the duration of migraines within 4 week intervals, and the average 4 week duration within 12 week intervals.', 'unitOfMeasure': 'migraine hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Monthly Headache Hours, Weeks 1-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.0', 'spread': '56.67', 'groupId': 'OG000'}, {'value': '-34.2', 'spread': '49.19', 'groupId': 'OG001'}, {'value': '-38.8', 'spread': '50.45', 'groupId': 'OG002'}, {'value': '-24.5', 'spread': '48.15', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1-12', 'description': 'Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.', 'unitOfMeasure': 'headache hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'title': 'Physical Functioning', 'categories': [{'measurements': [{'value': '0.9', 'spread': '5.78', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '6.88', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '6.74', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '6.43', 'groupId': 'OG003'}]}]}, {'title': 'Role Physical', 'categories': [{'measurements': [{'value': '3.0', 'spread': '6.54', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '7.65', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '7.72', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '6.78', 'groupId': 'OG003'}]}]}, {'title': 'Bodily Pain', 'categories': [{'measurements': [{'value': '4.5', 'spread': '8.27', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '8.37', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '9.12', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '8.70', 'groupId': 'OG003'}]}]}, {'title': 'General Health', 'categories': [{'measurements': [{'value': '1.2', 'spread': '6.78', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '7.22', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '7.54', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '6.52', 'groupId': 'OG003'}]}]}, {'title': 'Vitality', 'categories': [{'measurements': [{'value': '2.3', 'spread': '7.91', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '8.36', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '8.61', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '7.43', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks. All scales are on a range of 0 to 100, with 0 being the worst and 100 being the best. Scales are reported separately. Increases from baseline indicate improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo. The Week 12 scores only include participants who completed the Week 12 visit.'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life (EQ-5D-5L) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '198', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'title': 'Mobility', 'categories': [{'title': 'No problems', 'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}, {'title': 'Slight problems', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}, {'title': 'Moderate problems', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Severe problems', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Extreme problems', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Self-care', 'categories': [{'title': 'No problems', 'measurements': [{'value': '206', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}, {'value': '195', 'groupId': 'OG003'}]}, {'title': 'Slight problems', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Moderate problems', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Severe problems', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Extreme problems', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Usual Activities', 'categories': [{'title': 'No problems', 'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}, {'value': '172', 'groupId': 'OG003'}]}, {'title': 'Slight problems', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}, {'title': 'Moderate problems', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': 'Severe problems', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Extreme problems', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Pain/Discomfort', 'categories': [{'title': 'No problems', 'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}, {'title': 'Slight problems', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}, {'title': 'Moderate problems', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}, {'title': 'Severe problems', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': 'Extreme problems', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anxiety/Depression', 'categories': [{'title': 'No problems', 'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}, {'title': 'Slight problems', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}, {'title': 'Moderate problems', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Severe problems', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Extreme problems', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of 5 dimension/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo. The Week 12 scores only include participants who completed the Week 12 visit.'}, {'type': 'SECONDARY', 'title': 'Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '198', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg ALD403', 'description': 'Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG001', 'title': '100 mg ALD403', 'description': 'Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG002', 'title': '30 mg ALD403', 'description': 'Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '4.22', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '3.90', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '3.95', 'groupId': 'OG002'}, {'value': '-1.7', 'spread': '4.33', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'The ASC-12 includes 12 questions about the frequency of various allodynia symptoms in association with headache attacks. For individuals with more than one type of headache, questions are directed to the "most severe type of headache." Each item is measured in a Likert type scale option with response categories: "Does not apply to me", "never", "rarely", "less than half the time", and "half the time or more". ASC items were scored as 0 (i.e., never, rarely or does not apply to me), 1 (less than half the time), and 2 (half the time or more), yielding scores that ranged from 0 to 24. If a single item is missing, it is scored as a 0. If more than one item is missing the total score will be missing. The interpretation of the total score is, 0-2: none; 3-5: mild; 6-8: moderate; greater than or equal to 9: severe.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population - all randomized participants who received investigational product or placebo. The Week 12 scores only include participants who completed the Week 12 visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '300 mg ALD403', 'description': 'Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'FG001', 'title': '100 mg ALD403', 'description': 'Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'FG002', 'title': '30 mg ALD403', 'description': 'Participants were randomized to receive a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants were randomized to receive a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '225'}, {'groupId': 'FG002', 'numSubjects': '224'}, {'groupId': 'FG003', 'numSubjects': '225'}]}, {'type': 'Participants Treated', 'comment': '2 participants received duplicate randomization, participants are summarized in first group assigned', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '221'}, {'groupId': 'FG002', 'numSubjects': '223'}, {'groupId': 'FG003', 'numSubjects': '222'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '172'}, {'groupId': 'FG002', 'numSubjects': '170'}, {'groupId': 'FG003', 'numSubjects': '165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '60'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Study Burden', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'A total of 2413 participants signed the ICF, of which 898 participants met the entry criteria and were randomized into the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}, {'value': '888', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '300 mg ALD403', 'description': 'Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'BG001', 'title': '100 mg ALD403', 'description': 'Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'BG002', 'title': '30 mg ALD403', 'description': 'Participants were randomized to receive a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants were randomized to receive a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'spread': '11.72', 'groupId': 'BG000'}, {'value': '40.0', 'spread': '10.66', 'groupId': 'BG001'}, {'value': '39.1', 'spread': '11.54', 'groupId': 'BG002'}, {'value': '39.9', 'spread': '11.67', 'groupId': 'BG003'}, {'value': '39.8', 'spread': '11.39', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}, {'value': '749', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '139', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '161', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}, {'value': '188', 'groupId': 'BG003'}, {'value': '727', 'groupId': 'BG004'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}, {'value': '744', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}, {'value': '748', 'groupId': 'BG004'}]}]}, {'title': 'Georgia', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '140', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of migraine days', 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '2.59', 'groupId': 'BG000'}, {'value': '7.5', 'spread': '2.60', 'groupId': 'BG001'}, {'value': '7.9', 'spread': '2.70', 'groupId': 'BG002'}, {'value': '7.5', 'spread': '2.42', 'groupId': 'BG003'}, {'value': '7.7', 'spread': '2.58', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Self reported average number of migraine days per 28-day period in the 3 months prior to screening.', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety population includes all participants who received study drug or placebo. 2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-24', 'size': 3562470, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-19T08:00', 'hasProtocol': True}, {'date': '2017-05-18', 'size': 5007101, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-19T08:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 898}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'dispFirstSubmitDate': '2018-09-18', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-04', 'studyFirstSubmitDate': '2015-09-22', 'dispFirstSubmitQcDate': '2018-09-18', 'resultsFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2015-09-24', 'dispFirstPostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-04', 'studyFirstPostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Monthly Migraine Days (Weeks 1-12)', 'timeFrame': 'Week 1-12', 'description': 'Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12'}], 'secondaryOutcomes': [{'measure': '75% Migraine Responder Rate', 'timeFrame': 'Week 1-12', 'description': 'Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.'}, {'measure': '75% Migraine Responder Rate', 'timeFrame': 'Week 1-4', 'description': 'Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.'}, {'measure': '50% Migraine Responder Rate', 'timeFrame': 'Week 1-12', 'description': 'Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline'}, {'measure': 'Percentage of Participants With a Migraine on the Day After Dosing', 'timeFrame': '1 day', 'description': 'The percentage of participants with a migraine on the day after dosing, where Day 0 is treatment day and Day 1 is the day after dosing'}, {'measure': '75% Headache Responder Rate', 'timeFrame': 'Week 1-12', 'description': 'Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.'}, {'measure': '50% Headache Responder Rate', 'timeFrame': 'Week 1-12', 'description': 'Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline.'}, {'measure': '100% Migraine Responder Rate', 'timeFrame': 'Week 1-12', 'description': 'Participants with a reduction in migraine days of 100% over Weeks 1 to 12, as compared with baseline'}, {'measure': '100% Headache Responder Rate', 'timeFrame': 'Week 1-12', 'description': 'Participants with a reduction in headache days of 100% over Weeks 1 to 12, as compared with baseline.'}, {'measure': 'Change From Baseline in Acute Migraine Medication Days (Weeks 1-12)', 'timeFrame': 'Week 1-12', 'description': 'The change in number of days with any triptan or ergotamine use as recorded in the eDiary.'}, {'measure': 'Change From Baseline in Average Daily Migraine Prevalence to Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'The change in the percentage of days where a participant has a migraine from baseline to Week 4.'}, {'measure': 'Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication', 'timeFrame': 'Week 1-12', 'description': 'The percentage of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.'}, {'measure': 'Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication', 'timeFrame': 'Week 1-12', 'description': 'The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.'}, {'measure': 'Change From Baseline in Monthly Headache Days (Weeks 1-12)', 'timeFrame': 'Week 1-12', 'description': 'Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.'}, {'measure': 'Percent of Headaches With Severe Intensity', 'timeFrame': 'Week 1-12', 'description': 'Summary of percent of headaches with severe intensity over Weeks 1-12.'}, {'measure': 'Percent of Migraines With Severe Intensity', 'timeFrame': 'Week 1-12', 'description': 'Summary of percent of migraines with severe intensity over Week 1-12.'}, {'measure': 'Change From Baseline in Monthly Migraine Hours (Weeks 1-12)', 'timeFrame': 'Week 1-12', 'description': 'Migraine hours are the sum of the duration of migraines within 4 week intervals, and the average 4 week duration within 12 week intervals.'}, {'measure': 'Change From Baseline in Monthly Headache Hours, Weeks 1-12', 'timeFrame': 'Week 1-12', 'description': 'Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.'}, {'measure': 'Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores', 'timeFrame': 'Baseline to Week 12', 'description': 'The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks. All scales are on a range of 0 to 100, with 0 being the worst and 100 being the best. Scales are reported separately. Increases from baseline indicate improvement.'}, {'measure': 'Health Related Quality of Life (EQ-5D-5L) at Week 12', 'timeFrame': 'Week 12', 'description': 'The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of 5 dimension/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.'}, {'measure': 'Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score', 'timeFrame': 'Baseline to Week 12', 'description': 'The ASC-12 includes 12 questions about the frequency of various allodynia symptoms in association with headache attacks. For individuals with more than one type of headache, questions are directed to the "most severe type of headache." Each item is measured in a Likert type scale option with response categories: "Does not apply to me", "never", "rarely", "less than half the time", and "half the time or more". ASC items were scored as 0 (i.e., never, rarely or does not apply to me), 1 (less than half the time), and 2 (half the time or more), yielding scores that ranged from 0 to 24. If a single item is missing, it is scored as a 0. If more than one item is missing the total score will be missing. The interpretation of the total score is, 0-2: none; 3-5: mild; 6-8: moderate; greater than or equal to 9: severe.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Migraine Disorders']}, 'referencesModule': {'references': [{'pmid': '36284281', 'type': 'DERIVED', 'citation': 'Pozo-Rosich P, Dodick DW, Ettrup A, Hirman J, Cady R. Shift in diagnostic classification of migraine after initiation of preventive treatment with eptinezumab: post hoc analysis of the PROMISE studies. BMC Neurol. 2022 Oct 25;22(1):394. doi: 10.1186/s12883-022-02914-9.'}, {'pmid': '35436857', 'type': 'DERIVED', 'citation': 'Apelian R, Boyle L, Hirman J, Asher D. Measuring dose-related efficacy of eptinezumab for migraine prevention: post hoc analysis of PROMISE-1 and PROMISE-2. J Headache Pain. 2022 Apr 18;23(1):48. doi: 10.1186/s10194-022-01418-8.'}, {'pmid': '35302389', 'type': 'DERIVED', 'citation': 'Ashina M, McAllister P, Cady R, Hirman J, Ettrup A. Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2. Cephalalgia. 2022 Jul;42(8):696-704. doi: 10.1177/03331024221077646. Epub 2022 Mar 18.'}, {'pmid': '35131090', 'type': 'DERIVED', 'citation': 'Martin V, Nagy AJ, Janelidze M, Giorgadze G, Hirman J, Cady R, Mehta L, Buse DC. Impact of Baseline Characteristics on the Efficacy and Safety of Eptinezumab in Patients With Migraine: Subgroup Analyses of PROMISE-1 and PROMISE-2. Clin Ther. 2022 Mar;44(3):389-402. doi: 10.1016/j.clinthera.2022.01.006. Epub 2022 Feb 5.'}, {'pmid': '35130836', 'type': 'DERIVED', 'citation': 'Lipton RB, Charleston L 4th, Tassorelli C, Brevig T, Hirman J, Cady R. Patient-reported outcomes, health-related quality of life, and acute medication use in patients with a >/= 75% response to eptinezumab: subgroup pooled analysis of the PROMISE trials. J Headache Pain. 2022 Feb 7;23(1):23. doi: 10.1186/s10194-022-01386-z.'}, {'pmid': '34823467', 'type': 'DERIVED', 'citation': 'Smith TR, Spierings ELH, Cady R, Hirman J, Ettrup A, Shen V. Cardiovascular outcomes in adults with migraine treated with eptinezumab for migraine prevention: pooled data from four randomized, double-blind, placebo-controlled studies. J Headache Pain. 2021 Nov 25;22(1):143. doi: 10.1186/s10194-021-01360-1.'}, {'pmid': '33781209', 'type': 'DERIVED', 'citation': 'Smith TR, Spierings ELH, Cady R, Hirman J, Schaeffler B, Shen V, Sperling B, Brevig T, Josiassen MK, Brunner E, Honeywell L, Mehta L. Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials. J Headache Pain. 2021 Mar 30;22(1):16. doi: 10.1186/s10194-021-01227-5.'}, {'pmid': '33250209', 'type': 'DERIVED', 'citation': 'Smith TR, Janelidze M, Chakhava G, Cady R, Hirman J, Allan B, Pederson S, Smith J, Schaeffler B. Eptinezumab for the Prevention of Episodic Migraine: Sustained Effect Through 1 Year of Treatment in the PROMISE-1 Study. Clin Ther. 2020 Dec;42(12):2254-2265.e3. doi: 10.1016/j.clinthera.2020.11.007. Epub 2020 Nov 27.'}, {'pmid': '32075406', 'type': 'DERIVED', 'citation': 'Ashina M, Saper J, Cady R, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Smith J. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020 Mar;40(3):241-254. doi: 10.1177/0333102420905132. Epub 2020 Feb 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess ALD403 in the prevention of migraine headache in frequent episodic migraineurs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)\n* History of migraine ≥ 12 months with\n\n * ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) in each 28 day period in the 3 months prior to screening\n * During the 28 days following the screening visit, the subject experiences ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) as recorded in the eDiary\n* No use of any botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck 4 months prior to screening and during the 28 day period prior to randomization\n* Headache eDiary was completed on at least 25 of the 28 days prior to randomization\n\nExclusion Criteria:\n\n* Confounding pain syndromes, e.g. fibromyalgia, complex regional pain syndrome or any pain syndrome that requires regular analgesia\n* Psychiatric conditions that are uncontrolled and untreated, including conditions that are not controlled for a minimum of 6 months prior to screening\n* History or diagnosis of complicated migraine (ICHD- II, 2004 Section 1), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, migraine with brainstem aura, sporadic and familial hemiplegic migraine\n* Unable to differentiate migraine from other headaches\n* Have any clinically significant concurrent medical condition\n* Receipt of any monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial)\n* Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway'}, 'identificationModule': {'nctId': 'NCT02559895', 'acronym': 'PROMISE 1', 'briefTitle': 'A Multicenter Assessment of ALD403 in Frequent Episodic Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alder Biopharmaceuticals, Inc.'}, 'officialTitle': 'A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines', 'orgStudyIdInfo': {'id': 'ALD403-CLIN-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALD403 Dose Level 1', 'description': 'ALD403 Dose Level 1 (IV)', 'interventionNames': ['Drug: ALD403']}, {'type': 'EXPERIMENTAL', 'label': 'ALD403 Dose Level 2', 'description': 'ALD403 Dose Level 2 (IV)', 'interventionNames': ['Drug: ALD403']}, {'type': 'EXPERIMENTAL', 'label': 'ALD403 Dose Level 3', 'description': 'ALD403 Dose Level 3 (IV)', 'interventionNames': ['Drug: ALD403']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (IV)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ALD403', 'type': 'DRUG', 'otherNames': ['Eptinezumab-jjmr', 'Vyepti'], 'armGroupLabels': ['ALD403 Dose Level 1', 'ALD403 Dose Level 2', 'ALD403 Dose Level 3']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 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