Viewing Study NCT02542605

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 3:30 AM

Ignite Modification Date: 2026-03-06 @ 5:55 PM

Study NCT ID: NCT02542605

Status: COMPLETED

Last Update Posted: 2019-06-03

First Post: 2015-09-03

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C000605816', 'term': 'erenumab'}, {'id': 'D051219', 'term': 'Pituitary Adenylate Cyclase-Activating Polypeptide'}], 'ancestors': [{'id': 'D009414', 'term': 'Nerve Growth Factors'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', 'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early due to slow recruitment rate.'}}, 'adverseEventsModule': {'timeFrame': 'From first dose of investigational product (placebo or erenumab) up to 85 days (up to 12 weeks).', 'description': 'Other Adverse Events summarizes the non-serious occurrences of AEs that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Day 1-7', 'description': 'Participants were randomized to receive matching erenumab placebo intravenously over 30 minutes on study day 1 of Part B randomization phase.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 6, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Erenumab Day 1-7', 'description': 'Participants were randomized to receive 140 mg erenumab intravenously over 30 minutes on study day 1 of Part B randomization phase.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Day 8-EOS', 'description': 'On day 8 of Part B randomization phase, participants were administered 100 pmol/kg of PACAP-38, having received matching erenumab placebo on day 1. Participants were followed up for 11 weeks to EOS.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Erenumab Day 8-EOS', 'description': 'On day 8 of Part B randomization phase, participants were administered 100 pmol/kg of PACAP-38, having received 140 mg erenumab intravenously on day 1. Participants were followed up for 11 weeks to EOS.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiac discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyperacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ocular discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hunger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thirst decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Joint lock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Head discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Leukocyturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a MLA Within 24 Hours of Challenge Agent Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': 'Participants with MLA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Participants without MLA', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B randomization phase day 8 plus 24 hours.', 'description': 'On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion.\n\nA MLA was defined as fulfilling 1 of the 2 criteria:\n\n1. Headache with at least 2 of the following characteristics: unilateral location, pulsating quality, moderate or severe pain intensity, aggravated by/causing avoidance of routine physical activity. Additionally, during the headache at least 1 of the following: nausea and/or vomiting, photophobia or phonophobia.\n2. Headache described as mimicking usual migraine attack treated with triptan.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Headache Within 24 Hours of Challenge Agent Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': 'Participants with headaches', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Participants without headaches', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B randomization phase day 8 plus 24 hours.', 'description': 'On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': 'Participants with TEAEs from day 1 to 7', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with TEAEs from day 8 to EOS', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs with fatal outcome', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B randomization phase day 1 until EOS (up to 12 weeks).', 'description': 'TEAEs were summarised for days 1 to 7 after the participants received placebo or erenumab infusion on day 1 of the Part B randomization phase. TEAEs were also summarized from day 8 to end of study (EOS) after participants had received both investigational product (placebo or erenumab) and the second dose of PACAP-38 on day 8.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': '1 hour post-dose day 1: systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': '1 hour post-dose day 1: diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '6.4', 'groupId': 'OG001'}]}]}, {'title': '8 hours post-dose day 8: systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '6.2', 'groupId': 'OG001'}]}]}, {'title': '8 hours post-dose day 8: diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '-9.6', 'spread': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'EOS: systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'EOS: diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization phase baseline and day 1, day 8 and EOS (week 12).', 'description': 'Systolic and diastolic BP was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.', 'unitOfMeasure': 'millimeters of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Heart Rate at Day 1, Day 8 and EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': '1 hour post-dose day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': '8 hours post-dose day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization phase baseline and day 1, day 8 and EOS (week 12).', 'description': 'Heart rate was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Respiratory Rate at Day 1, Day 8 and EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': '1 hour post-dose day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': '8 hours post-dose day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization phase baseline and day 1, day 8 and EOS (week 12).', 'description': 'Respiratory rate was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.', 'unitOfMeasure': 'breaths/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Temperature at Day 1, Day 8 and EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': '1 hour post-dose day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': '8 hours post-dose day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization phase baseline and day 1, day 8 and EOS (week 12).', 'description': 'Temperature was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': 'Day 8 (Pre-PACAP-38 dose): ALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 9 (Post-PACAP-38 dose): ALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'EOS: ALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 (Pre-PACAP-38 dose): ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 9 (Post-PACAP-38 dose): ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'EOS: ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 (Pre-PACAP-38 dose): AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 9 (Post-PACAP-38 dose): AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'EOS: AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization phase baseline and day 8, day 9 and EOS (week 12).', 'description': 'ALP, ALT and AST were assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.', 'unitOfMeasure': 'Units/Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Total Bilirubin at Day 8, Day 9 and EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': 'Day 8 (Pre-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4211', 'spread': '3.6356', 'groupId': 'OG000'}, {'value': '-1.4849', 'spread': '0.8532', 'groupId': 'OG001'}]}]}, {'title': 'Day 9 (Post-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3229', 'spread': '1.3971', 'groupId': 'OG000'}, {'value': '-2.2980', 'spread': '1.0300', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0804', 'spread': '3.0270', 'groupId': 'OG000'}, {'value': '1.3191', 'spread': '3.5099', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Total bilirubin was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.', 'unitOfMeasure': 'micromol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Blood Urea at Day 8, Day 9 and EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': 'Day 8 (Pre-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0629', 'spread': '0.9274', 'groupId': 'OG000'}, {'value': '-0.0524', 'spread': '0.5270', 'groupId': 'OG001'}]}]}, {'title': 'Day 9 (Post-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1501', 'spread': '0.7552', 'groupId': 'OG000'}, {'value': '-0.5278', 'spread': '1.2592', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1961', 'spread': '0.7673', 'groupId': 'OG000'}, {'value': '0.0570', 'spread': '1.1286', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Blood urea was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.', 'unitOfMeasure': 'millimol/L (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Creatine Kinase at Day 8, Day 9 and EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': 'Day 8 (Pre-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '-22.4', 'spread': '51.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 9 (Post-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.8', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '-59.3', 'spread': '65.7', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '25.3', 'groupId': 'OG000'}, {'value': '-24.9', 'spread': '79.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Creatine Kinase was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Creatinine at Day 8, Day 9 and EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': 'Day 8 (Pre-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9890', 'spread': '6.0835', 'groupId': 'OG000'}, {'value': '-2.2526', 'spread': '3.1121', 'groupId': 'OG001'}]}]}, {'title': 'Day 9 (Post-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1450', 'spread': '7.3859', 'groupId': 'OG000'}, {'value': '-1.4733', 'spread': '3.4367', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5151', 'spread': '7.8109', 'groupId': 'OG000'}, {'value': '-0.3457', 'spread': '2.6598', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Creatinine was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.', 'unitOfMeasure': 'micromol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Direct Bilirubin at Day 8, Day 9 and EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': 'Day 8 (Pre-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0570', 'spread': '1.2948', 'groupId': 'OG000'}, {'value': '-1.0260', 'spread': 'NA', 'comment': 'Only 1 participant was analysed for this timepoint.', 'groupId': 'OG001'}]}]}, {'title': 'Day 9 (Post-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6270', 'spread': '0.5497', 'groupId': 'OG000'}, {'value': '-1.1115', 'spread': '0.1209', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1710', 'spread': '0.1710', 'groupId': 'OG000'}, {'value': '1.1970', 'spread': '0.0000', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Direct bilirubin was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.', 'unitOfMeasure': 'micromol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Eosinophil Count at Day 8, Day 9 and EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': 'Day 8 (Pre-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.013', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '-0.004', 'spread': '0.046', 'groupId': 'OG001'}]}]}, {'title': 'Day 9 (Post-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.035', 'spread': '0.076', 'groupId': 'OG000'}, {'value': '-0.002', 'spread': '0.066', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.041', 'spread': '0.060', 'groupId': 'OG000'}, {'value': '0.033', 'spread': '0.061', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Eosinophil count was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.', 'unitOfMeasure': '10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Blood Glucose at Day 8, Day 9 and EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': 'Day 8 (Pre-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1360', 'spread': '0.3103', 'groupId': 'OG000'}, {'value': '-0.2761', 'spread': '0.5961', 'groupId': 'OG001'}]}]}, {'title': 'Day 9 (Post-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2290', 'spread': '0.2350', 'groupId': 'OG000'}, {'value': '0.0427', 'spread': '0.2432', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3183', 'spread': '0.3395', 'groupId': 'OG000'}, {'value': '-0.1237', 'spread': '0.3645', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Blood glucose was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Hemoglobin A1C (Fraction of 1) at Day 8, Day 9 and EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': 'Day 8 (Pre-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0003', 'spread': '0.0007', 'groupId': 'OG000'}, {'value': '0.0001', 'spread': '0.0007', 'groupId': 'OG001'}]}]}, {'title': 'Day 9 (Post-PACAP-38 dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'spread': '0.0005', 'groupId': 'OG000'}, {'value': '0.0002', 'spread': '0.0010', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0003', 'spread': '0.0012', 'groupId': 'OG000'}, {'value': '0.0002', 'spread': '0.0012', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Hemoglobin A1C was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.', 'unitOfMeasure': 'fraction of 1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Mean Erenumab Serum Concentration at 1 Hour (C1h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'spread': '9.72', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization phase 1 hour post-dose day 1.', 'description': 'The mean serum erenumab concentration at 1 hour post-dose on day 1 of Part B randomization phase is presented.', 'unitOfMeasure': 'micrograms per milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set consisted of all randomized participants who received erenumab and have at least 1 PK concentration result.'}, {'type': 'SECONDARY', 'title': 'PK: Mean Area Under the Concentration-time Curve From Time 0 to 84 Days Post-dose (AUC84d)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '877', 'spread': '131', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B randomization phase baseline and 84 days post-dose.', 'description': 'The mean AUC84d for erenumab for the Part B randomization phase is presented.', 'unitOfMeasure': 'day*mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set consisted of all randomized participants who received erenumab and have at least 1 PK concentration result.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Erenumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'title': 'Binding antibody positive at/before baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Neutralizing antibody positive at/before baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Binding antibody positive post-baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Neutralizing antibody positive post-baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B randomization phase baseline and EOS.', 'description': 'Participants were tested for binding antibodies and neutralizing antibodies at baseline and following treatment with erenumab.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set for erenumab consisted of all randomized participants who received at least 1 dose of erenumab in Part B.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B randomization phase baseline and EOS.', 'description': 'At baseline, 12-lead ECGs were performed in a standardized method, in triplicate, and approximately 30 seconds apart, prior to blood draws or other invasive procedures. Single ECGs were performed from Day 1 to EOS. ECG results were reviewed by the investigator and classified as: normal, abnormal not clinically significant or abnormal, clinically significant. The number of participants with abnormal, clinically significant changes in ECG results at EOS are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes in Physical Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B randomization phase baseline and EOS.', 'description': 'Physical examinations were performed by an investigator and any abnormal findings, judged to be clinically significant were recorded as an AE. The number of participants with clinically significant changes in physical parameters at EOS are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes in Neurological Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B randomization phase baseline and EOS.', 'description': 'Neurological examinations including assessment of cranial nerves, motor system, sensory system (including testing for pain sensation \\[pin prick\\], light touch sensation \\[brush\\], von Frey, and vibratory sense), reflexes, and cerebellar function were performed by the investigator and classified as normal or abnormal. Any abnormal findings, judged by the investigator to be clinically significant, were recorded as an AE. The number of participants with clinically significant changes in neurological assessments at EOS are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PACAP-38 Challenge Agent', 'description': 'In Part A, cohorts 1 to 4 (of 2 to 5 participants each) sequentially received an intravenous infusion of 10 picomol/kilogram/minute (pmol/kg/minute) PACAP-38 over 2.5, 5, 7.5 and 10 minutes, respectively. Dose selection in Part A enabled the dose for Part B to be determined.\n\nPACAP-38 naïve participants entered the study at Part B. On day 1 of the Part B challenge phase participants received the dose of PACAP-38 determined from Part A of the study: 100 pmol/kg (administered as 10 pmol/kg/minute PACAP-38 over 10 minutes). Responders who experienced a MLA within 24 hours were screened for the randomization phase.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}, {'id': 'FG002', 'title': 'Erenumab', 'description': 'Participants were randomized to receive 140 milligrams (mg) erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.'}], 'periods': [{'title': 'Part A: PACAP-38 Dose Selection Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Received PACAP-38', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Proceeded to Part B Randomization Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part B: Challenge Phase', 'milestones': [{'type': 'STARTED', 'comment': 'Participants starting Part B are all PACAP-38 naïve and did not participate in Part A.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Received PACAP-38', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Proceeded to Randomization Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part B: Randomization Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Not PACAP-38 naïve Participants', 'comment': 'Participants received PACAP-38 during Part A dose selection.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'PACAP-38 naïve Participants', 'comment': 'Participants joined the study at Part B and did not receive PACAP-38 in Part A.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Received Placebo/Erenumab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled in 2 centers in Belgium and the Netherlands from November 2015 until November 2017 when the study was terminated early due to slow recruitment rate. Additionally, 2 participants were enrolled at a center in the United States for Part A prior to this study site being closed.', 'preAssignmentDetails': '12 participants received treatment in Part A to determine the lowest pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) dose that triggered a migraine-like attack (MLA). PACAP-38 responders from Part A and PACAP-38 naïve participants were randomized in Part B (17 in total). 35 participants were enrolled in the study (Parts A and B).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PACAP-38 Challenge Agent', 'description': 'In Part A, cohorts 1 to 4 (of 2 to 5 participants each) sequentially received an intravenous infusion of 10 pmol/kg/minute PACAP-38 over 2.5, 5, 7.5 and 10 minutes, respectively. Dose selection in Part A enabled the dose for Part B to be determined.\n\nPACAP-38 naïve participants entered the study at Part B. On day 1 of the Part B challenge phase participants received the dose of PACAP-38 determined from Part A of the study: 100 pmol/kg (administered as 10 pmol/kg/minute PACAP-38 over 10 minutes). Responders who experienced a MLA within 24 hours were screened for the randomization phase.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'spread': '6.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 - 64 years', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Black (or African American)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Multiple (Asian-White)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.13', 'spread': '7.72', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '69.433', 'spread': '14.656', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '24.4738', 'spread': '4.2926', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The overall baseline population consists of all participants who received at least 1 dose of PACAP-38 in either Part A or Part B of the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-01', 'size': 3667048, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-09-20T17:11', 'hasProtocol': True}, {'date': '2017-05-17', 'size': 656527, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-09-20T17:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-27', 'studyFirstSubmitDate': '2015-09-03', 'resultsFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-27', 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a MLA Within 24 Hours of Challenge Agent Infusion', 'timeFrame': 'Part B randomization phase day 8 plus 24 hours.', 'description': 'On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion.\n\nA MLA was defined as fulfilling 1 of the 2 criteria:\n\n1. Headache with at least 2 of the following characteristics: unilateral location, pulsating quality, moderate or severe pain intensity, aggravated by/causing avoidance of routine physical activity. Additionally, during the headache at least 1 of the following: nausea and/or vomiting, photophobia or phonophobia.\n2. Headache described as mimicking usual migraine attack treated with triptan.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Headache Within 24 Hours of Challenge Agent Infusion', 'timeFrame': 'Part B randomization phase day 8 plus 24 hours.', 'description': 'On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Part B randomization phase day 1 until EOS (up to 12 weeks).', 'description': 'TEAEs were summarised for days 1 to 7 after the participants received placebo or erenumab infusion on day 1 of the Part B randomization phase. TEAEs were also summarized from day 8 to end of study (EOS) after participants had received both investigational product (placebo or erenumab) and the second dose of PACAP-38 on day 8.'}, {'measure': 'Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS', 'timeFrame': 'Part B randomization phase baseline and day 1, day 8 and EOS (week 12).', 'description': 'Systolic and diastolic BP was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.'}, {'measure': 'Mean Change From Baseline in Heart Rate at Day 1, Day 8 and EOS', 'timeFrame': 'Part B randomization phase baseline and day 1, day 8 and EOS (week 12).', 'description': 'Heart rate was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.'}, {'measure': 'Mean Change From Baseline in Respiratory Rate at Day 1, Day 8 and EOS', 'timeFrame': 'Part B randomization phase baseline and day 1, day 8 and EOS (week 12).', 'description': 'Respiratory rate was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.'}, {'measure': 'Mean Change From Baseline in Temperature at Day 1, Day 8 and EOS', 'timeFrame': 'Part B randomization phase baseline and day 1, day 8 and EOS (week 12).', 'description': 'Temperature was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.'}, {'measure': 'Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS', 'timeFrame': 'Part B randomization phase baseline and day 8, day 9 and EOS (week 12).', 'description': 'ALP, ALT and AST were assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.'}, {'measure': 'Mean Change From Baseline in Total Bilirubin at Day 8, Day 9 and EOS', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Total bilirubin was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.'}, {'measure': 'Mean Change From Baseline in Blood Urea at Day 8, Day 9 and EOS', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Blood urea was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.'}, {'measure': 'Mean Change From Baseline in Creatine Kinase at Day 8, Day 9 and EOS', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Creatine Kinase was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.'}, {'measure': 'Mean Change From Baseline in Creatinine at Day 8, Day 9 and EOS', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Creatinine was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.'}, {'measure': 'Mean Change From Baseline in Direct Bilirubin at Day 8, Day 9 and EOS', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Direct bilirubin was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.'}, {'measure': 'Mean Change From Baseline in Eosinophil Count at Day 8, Day 9 and EOS', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Eosinophil count was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.'}, {'measure': 'Mean Change From Baseline in Blood Glucose at Day 8, Day 9 and EOS', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Blood glucose was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.'}, {'measure': 'Mean Change From Baseline in Hemoglobin A1C (Fraction of 1) at Day 8, Day 9 and EOS', 'timeFrame': 'Part B randomization baseline and day 8, day 9 and EOS (week 12).', 'description': 'Hemoglobin A1C was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.'}, {'measure': 'Pharmacokinetics (PK): Mean Erenumab Serum Concentration at 1 Hour (C1h)', 'timeFrame': 'Part B randomization phase 1 hour post-dose day 1.', 'description': 'The mean serum erenumab concentration at 1 hour post-dose on day 1 of Part B randomization phase is presented.'}, {'measure': 'PK: Mean Area Under the Concentration-time Curve From Time 0 to 84 Days Post-dose (AUC84d)', 'timeFrame': 'Part B randomization phase baseline and 84 days post-dose.', 'description': 'The mean AUC84d for erenumab for the Part B randomization phase is presented.'}, {'measure': 'Number of Participants With Anti-Erenumab Antibodies', 'timeFrame': 'Part B randomization phase baseline and EOS.', 'description': 'Participants were tested for binding antibodies and neutralizing antibodies at baseline and following treatment with erenumab.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters', 'timeFrame': 'Part B randomization phase baseline and EOS.', 'description': 'At baseline, 12-lead ECGs were performed in a standardized method, in triplicate, and approximately 30 seconds apart, prior to blood draws or other invasive procedures. Single ECGs were performed from Day 1 to EOS. ECG results were reviewed by the investigator and classified as: normal, abnormal not clinically significant or abnormal, clinically significant. The number of participants with abnormal, clinically significant changes in ECG results at EOS are presented.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Physical Parameters', 'timeFrame': 'Part B randomization phase baseline and EOS.', 'description': 'Physical examinations were performed by an investigator and any abnormal findings, judged to be clinically significant were recorded as an AE. The number of participants with clinically significant changes in physical parameters at EOS are presented.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Neurological Assessments', 'timeFrame': 'Part B randomization phase baseline and EOS.', 'description': 'Neurological examinations including assessment of cranial nerves, motor system, sensory system (including testing for pain sensation \\[pin prick\\], light touch sensation \\[brush\\], von Frey, and vibratory sense), reflexes, and cerebellar function were performed by the investigator and classified as normal or abnormal. Any abnormal findings, judged by the investigator to be clinically significant, were recorded as an AE. The number of participants with clinically significant changes in neurological assessments at EOS are presented.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Migraine', 'Headache', 'Migraine Headache', 'Headache, Migraine', 'Amgen'], 'conditions': ['Migraine']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥ 18 to ≤ 45 years of age upon entry into screening\n* History of migraine headaches without aura for ≥ 6 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-II) (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report\n* Migraine frequency: ≥ 1 and ≤ 5 migraine days per month in each of the 3 months prior to screening\n\nExclusion Criteria:\n\n* History of migraine with aura, cluster headache or hemiplegic migraine headache according to the IHS Classification ICHD-II (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report\n* ≥ 6 migraine days per month in the last 3 months prior to study enrollment and during screening period\n* Other headache disorders (except for episodic tension-type headache \\<5 days/month)'}, 'identificationModule': {'nctId': 'NCT02542605', 'briefTitle': 'To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients', 'orgStudyIdInfo': {'id': '20140207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PACAP-38 Challenge Agent', 'description': 'In Part A, 4 cohorts of 2 to 5 participants sequentially received an intravenous infusion of 10 picomol/kilogram/minute (pmol/kg/minute) PACAP-38 for 2.5, 5, 7.5 and 10 minutes each in order to determine the dose for Part B.', 'interventionNames': ['Drug: PACAP-38 Challenge Agent']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1. On day 8 participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.', 'interventionNames': ['Drug: Placebo', 'Drug: PACAP-38 Challenge Agent']}, {'type': 'EXPERIMENTAL', 'label': 'Erenumab', 'description': 'Participants were randomized to receive 140 milligrams (mg) erenumab by intravenous administration over 30 minutes on day 1 in Part B. On day 8 participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.', 'interventionNames': ['Drug: Erenumab', 'Drug: PACAP-38 Challenge Agent']}], 'interventions': [{'name': 'Erenumab', 'type': 'DRUG', 'otherNames': ['AMG 334', 'Aimovig™'], 'description': 'Administered once on day 1 of Part B of the study by intravenous infusion.', 'armGroupLabels': ['Erenumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered once on day 1 of Part B of the study by intravenous infusion.', 'armGroupLabels': ['Placebo']}, {'name': 'PACAP-38 Challenge Agent', 'type': 'DRUG', 'otherNames': ['Pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38)'], 'description': 'Administered by intravenous infusion during Part A of the study for dose selection for Part B.\n\nAdministered by intravenous infusion on day 8 in Part B as a challenge agent to induce a migraine-like attack.', 'armGroupLabels': ['Erenumab', 'PACAP-38 Challenge Agent', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2333 CL', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}