Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT02174861
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2014-05-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000605816', 'term': 'erenumab'}]}}, '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}}, 'adverseEventsModule': {'timeFrame': 'From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks).', 'description': 'Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Erenumab', 'description': 'Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks.\n\nParticipants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.', 'otherNumAtRisk': 609, 'deathsNumAtRisk': 609, 'otherNumAffected': 162, 'seriousNumAtRisk': 609, 'deathsNumAffected': 0, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 44}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 96}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Myocardial bridging', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alcoholic liver disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Post procedural oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Medication overuse headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Radicular syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vestibular migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 609, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erenumab', 'description': 'Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks.\n\nParticipants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '398', 'groupId': 'OG000'}]}]}, {'title': 'Adverse event grade ≥ 2', 'categories': [{'measurements': [{'value': '302', 'groupId': 'OG000'}]}]}, {'title': 'Adverse event grade ≥ 3', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Adverse event grade ≥ 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-related adverse events', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'AE leading to discontinuation of erenumab', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Fatal adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks).', 'description': 'Adverse events (AEs) were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 1 = mild AE, asymptomatic or mild symptoms; Grade 2 = Moderate AE; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; urgent intervention indicated; Grade 5 = Death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of erenumab'}, {'type': 'PRIMARY', 'title': 'CHU Substudy: Number of Participants Able to Administer a Full Dose of Erenumab in Home-use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erenumab 140 mg PFS', 'description': 'Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a prefilled syringe (PFS).'}, {'id': 'OG001', 'title': 'Erenumab 140 mg AI/Pen', 'description': 'Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a autoinjector/pen (AI/Pen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 29 (week 4) and day 57 (week 8) of the substudy', 'description': 'At the CHU substudy day 28 and day 56 visits, the site provided erenumab 140 mg to participants to self-administer at home on the following day. Study site staff then called the participants and asked if they administered a full, partial, or no dose of erenumab. A full dose was defined when the entire volume of both prefilled syringes or autoinjector/pens were injected.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of erenumab in the CHU substudy.'}, {'type': 'SECONDARY', 'title': 'Change From Study 20120295 Baseline in Monthly Migraine Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erenumab', 'description': 'Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks.\n\nParticipants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.11', 'spread': '4.53', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline at week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.72', 'spread': '6.22', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline at week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.38', 'spread': '6.50', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline at week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '560', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.63', 'spread': '6.49', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline at week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.36', 'spread': '6.29', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline at week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.72', 'spread': '6.53', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline at week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.29', 'spread': '6.64', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255', 'description': 'A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura.\n\nThe change from baseline in monthly migraine days was calculated as the number of migraine days during the 4 weeks prior to each study visit - the number of migraine days during the 4-week baseline phase.', 'unitOfMeasure': 'migraine days / month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The number of participants analyzed includes participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erenumab', 'description': 'Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks.\n\nParticipants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000', 'lowerLimit': '35.3', 'upperLimit': '43.3'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.6', 'groupId': 'OG000', 'lowerLimit': '41.6', 'upperLimit': '49.7'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '560', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000', 'lowerLimit': '41.6', 'upperLimit': '49.9'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000', 'lowerLimit': '49.2', 'upperLimit': '58.0'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '50.9', 'upperLimit': '60.2'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000', 'lowerLimit': '54.0', 'upperLimit': '63.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255', 'description': 'A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the 4 weeks prior to each study visit.\n\nAt least a 50% reduction from baseline (of study 20120295) in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the 4 weeks prior to each study visit \\* 100 / baseline monthly migraine days was less than or equal to -50%.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erenumab', 'description': 'Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks.\n\nParticipants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.53', 'spread': '7.26', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.59', 'spread': '4.62', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.01', 'spread': '4.96', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '560', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.96', 'spread': '5.03', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.39', 'spread': '4.99', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.58', 'spread': '5.00', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.97', 'spread': '5.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255', 'description': 'Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.', 'unitOfMeasure': 'acute migraine treatment days / month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erenumab', 'description': 'Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks.\n\nParticipants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '226.84', 'spread': '125.54', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline at week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-79.38', 'spread': '107.56', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline at week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-85.24', 'spread': '110.24', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '560', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-89.30', 'spread': '111.47', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-100.41', 'spread': '112.30', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-101.07', 'spread': '111.77', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-107.44', 'spread': '113.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255', 'description': 'The cumulative duration of any qualified headache between monthly doses of study drug regardless of acute treatment use.\n\nA qualified headache was defined as follows:\n\n* a qualified migraine headache (including an aura-only event that is treated with acute migraine-specific medication), or\n* a qualified non-migraine headache, which is a headache that lasted continuously for ≥ 4 hours and was not a qualified migraine headache, or\n* a headache of any duration for which acute headache treatment was administered.', 'unitOfMeasure': 'hours / month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'CHU Substudy: Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erenumab 140 mg PFS', 'description': 'Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a prefilled syringe (PFS).'}, {'id': 'OG001', 'title': 'Erenumab 140 mg AI/Pen', 'description': 'Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a autoinjector/pen (AI/Pen).'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event grade ≥ 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event grade ≥ 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event grade ≥ 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AE leading to discontinuation of erenumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fatal adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injection site reactions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Adverse device effects', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of erenumab in the CHU substudy to 28 days after last dose of erenumab in the CHU substudy; up to 12 weeks.', 'description': 'Adverse events were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.\n\nInjection site reactions were derived from a Medical Dictionary for Regulatory Activities (MedDRA) query using a list of pre-specified preferred terms.\n\nAn adverse device effect (ADE) is any adverse event related to the use of a medical device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of erenumab in the CHU substudy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Erenumab', 'description': 'Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks.\n\nParticipants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '609'}]}, {'type': 'Enrolled in CHU Substudy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '451'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}]}], 'dropWithdraws': [{'type': 'Decision by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '124'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 64 centers across North America and Europe from 30 June 2014 to 4 March 2016. Participants who completed the 12-week double-blind treatment of the parent Study 20120295 (NCT02066415) and met all Study 20130255 eligibility criteria were eligible for enrollment into this study.', 'preAssignmentDetails': 'Participants at sites in the United States, Sweden, and Germany had the option of enrolling in the Clinical Home Use (CHU) Substudy to assess their ability to self-administer 140 mg erenumab for in-home use. Participants in the substudy were randomized 1:1 to self-administer erenumab using either a prefilled syringe or autoinjector/pen.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Erenumab', 'description': 'Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks.\n\nParticipants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '11.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '18 - 64 years', 'measurements': [{'value': '608', 'groupId': 'BG000'}]}, {'title': '65 - 74 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '509', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '584', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '574', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-31', 'size': 1833644, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-24T15:40', 'hasProtocol': True}, {'date': '2016-10-07', 'size': 877687, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-24T15:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 609}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-03', 'studyFirstSubmitDate': '2014-05-28', 'resultsFirstSubmitDate': '2018-05-24', 'studyFirstSubmitQcDate': '2014-06-24', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-24', 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks).', 'description': 'Adverse events (AEs) were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 1 = mild AE, asymptomatic or mild symptoms; Grade 2 = Moderate AE; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; urgent intervention indicated; Grade 5 = Death related to AE.'}, {'measure': 'CHU Substudy: Number of Participants Able to Administer a Full Dose of Erenumab in Home-use', 'timeFrame': 'Day 29 (week 4) and day 57 (week 8) of the substudy', 'description': 'At the CHU substudy day 28 and day 56 visits, the site provided erenumab 140 mg to participants to self-administer at home on the following day. Study site staff then called the participants and asked if they administered a full, partial, or no dose of erenumab. A full dose was defined when the entire volume of both prefilled syringes or autoinjector/pens were injected.'}], 'secondaryOutcomes': [{'measure': 'Change From Study 20120295 Baseline in Monthly Migraine Days', 'timeFrame': '4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255', 'description': 'A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura.\n\nThe change from baseline in monthly migraine days was calculated as the number of migraine days during the 4 weeks prior to each study visit - the number of migraine days during the 4-week baseline phase.'}, {'measure': 'Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline', 'timeFrame': '4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255', 'description': 'A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the 4 weeks prior to each study visit.\n\nAt least a 50% reduction from baseline (of study 20120295) in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the 4 weeks prior to each study visit \\* 100 / baseline monthly migraine days was less than or equal to -50%.'}, {'measure': 'Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days', 'timeFrame': '4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255', 'description': 'Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.'}, {'measure': 'Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours', 'timeFrame': '4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255', 'description': 'The cumulative duration of any qualified headache between monthly doses of study drug regardless of acute treatment use.\n\nA qualified headache was defined as follows:\n\n* a qualified migraine headache (including an aura-only event that is treated with acute migraine-specific medication), or\n* a qualified non-migraine headache, which is a headache that lasted continuously for ≥ 4 hours and was not a qualified migraine headache, or\n* a headache of any duration for which acute headache treatment was administered.'}, {'measure': 'CHU Substudy: Number of Participants With Adverse Events', 'timeFrame': 'From first dose of erenumab in the CHU substudy to 28 days after last dose of erenumab in the CHU substudy; up to 12 weeks.', 'description': 'Adverse events were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.\n\nInjection site reactions were derived from a Medical Dictionary for Regulatory Activities (MedDRA) query using a list of pre-specified preferred terms.\n\nAn adverse device effect (ADE) is any adverse event related to the use of a medical device.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Migraine'], 'conditions': ['Treatment for Prevention of Chronic Migraine']}, 'referencesModule': {'references': [{'pmid': '35272533', 'type': 'BACKGROUND', 'citation': 'Zhou Y, Zhang F, Starcevic Manning M, Hu Z, Hsu CP, Chen PW, Peng C, Loop B, Mytych DT, Paiva da Silva Lima G. Immunogenicity of erenumab: A pooled analysis of six placebo-controlled trials with long-term extensions. Cephalalgia. 2022 Jul;42(8):749-760. doi: 10.1177/03331024221075621. Epub 2022 Mar 10.'}, {'pmid': '31707815', 'type': 'BACKGROUND', 'citation': 'Ashina M, Kudrow D, Reuter U, Dolezil D, Silberstein S, Tepper SJ, Xue F, Picard H, Zhang F, Wang A, Zhou Y, Hong F, Klatt J, Mikol DD. Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions. Cephalalgia. 2019 Dec;39(14):1798-1808. doi: 10.1177/0333102419888222. Epub 2019 Nov 10.'}, {'pmid': '34928306', 'type': 'DERIVED', 'citation': 'Ashina M, Goadsby PJ, Dodick DW, Tepper SJ, Xue F, Zhang F, Brennan F, Paiva da Silva Lima G. Assessment of Erenumab Safety and Efficacy in Patients With Migraine With and Without Aura: A Secondary Analysis of Randomized Clinical Trials. JAMA Neurol. 2022 Feb 1;79(2):159-168. doi: 10.1001/jamaneurol.2021.4678.'}, {'pmid': '34301173', 'type': 'DERIVED', 'citation': 'Tepper SJ, Ashina M, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Picard H, Cheng S, Chou DE, Zhang F, Klatt J, Mikol DD. Reduction in acute migraine-specific and non-specific medication use in patients treated with erenumab: post-hoc analyses of episodic and chronic migraine clinical trials. J Headache Pain. 2021 Jul 23;22(1):81. doi: 10.1186/s10194-021-01292-w.'}, {'pmid': '32216456', 'type': 'DERIVED', 'citation': 'Tepper SJ, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein SD, Winner P, Zhang F, Cheng S, Mikol DD. Long-term safety and efficacy of erenumab in patients with chronic migraine: Results from a 52-week, open-label extension study. Cephalalgia. 2020 May;40(6):543-553. doi: 10.1177/0333102420912726. Epub 2020 Mar 26.'}, {'pmid': '31852816', 'type': 'DERIVED', 'citation': 'Kudrow D, Pascual J, Winner PK, Dodick DW, Tepper SJ, Reuter U, Hong F, Klatt J, Zhang F, Cheng S, Picard H, Eisele O, Wang J, Latham JN, Mikol DD. Vascular safety of erenumab for migraine prevention. Neurology. 2020 Feb 4;94(5):e497-e510. doi: 10.1212/WNL.0000000000008743. Epub 2019 Dec 18.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'To assess the long-term safety and efficacy of erenumab.', 'detailedDescription': "This was a multicenter, 52-week, open-label study designed to assess the long-term safety and efficacy of erenumab in adults with chronic migraine. Participants who completed the 12-week double-blind treatment of the parent Study 20120295 (NCT02066415) and met all Study 20130255 eligibility criteria were eligible for enrollment into this study. Enrollment occurred within 14 days after the parent study's week 12 visit.\n\nThe initial dose used in the study was erenumab 70 mg every month (QM). The protocol was subsequently amended to increase the dose to erenumab 140 mg QM (Protocol Amendment 2). Participants who had already completed the week 28 visit (ie, midpoint of the study) at the time of Protocol Amendment 2 continued to receive open-label erenumab 70 mg QM for the remainder of the study. Participants who enrolled but had not completed the week 28 visit at the time of Protocol Amendment 2 increased the open-label erenumab dose from 70 mg QM to 140 mg QM at the next visit. All participants who enrolled after Protocol Amendment 2 received open-label erenumab 140 mg QM throughout the study.\n\nParticipants may elect to participate in a separate clinical home use (CHU) substudy to assess subjects' ability to self-administer 140 mg of erenumab for in-home use using either two prefilled syringes (PFS) or two prefilled autoinjector/pens (AI/pens). Enrollment in the 12-week substudy occurred at either week 12 or week 40 of study 20130255. Participants were randomized to self-administer erenumab using either the PFS or AI/pen on CHU days 29 and 57 at home."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '66 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject has provided informed consent prior to initiation of any study-specific activities/procedures\n2. Completed the 12-week study visit and did not end IP early during the double-blind treatment period of the AMG 334 20120295 (NCT02066415) parent study, and is appropriate for continued treatment.\n\nExclusion Criteria:\n\n1. Development of any unstable or clinically significant medical condition, laboratory or electrocardiogram (ECG) abnormality following randomization into the parent study, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n2. Systolic blood pressure (BP) 160 mm Hg and/or diastolic BP 100 mm Hg or greater at screening/Day 1.\n3. Subject who used excluded concomitant medications between week 8 and week 12 of the parent study'}, 'identificationModule': {'nctId': 'NCT02174861', 'briefTitle': 'A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'An Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 334', 'orgStudyIdInfo': {'id': '20130255'}, 'secondaryIdInfos': [{'id': '2013-005311-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erenumab', 'description': 'Participants received erenumab 70 mg once a month (QM) or 140 mg QM by subcutaneous injection for up to 52 weeks.', 'interventionNames': ['Drug: Erenumab']}], 'interventions': [{'name': 'Erenumab', 'type': 'DRUG', 'otherNames': ['AMG 334', 'Aimovig™'], 'description': 'Administered by subcutaneous injection once a month', 'armGroupLabels': ['Erenumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '06905', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33410', 'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United 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