Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-01-10 @ 8:04 PM
Study NCT ID:
NCT02797951
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2016-06-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003027', 'term': 'Cluster Headache'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D051303', 'term': 'Trigeminal Autonomic Cephalalgias'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628360', 'term': 'galcanezumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline through End of Study (Up to 4 Years)', 'description': 'All participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Galcanezumab 300 mg SC', 'description': 'Participants received 300 mg Galcanezumab administered SC up to once a month.', 'otherNumAtRisk': 164, 'deathsNumAtRisk': 164, 'otherNumAffected': 62, 'seriousNumAtRisk': 164, 'deathsNumAffected': 1, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 21, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 46, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Exposure to household chemicals', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cluster headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Completed suicide', 'notes': 'This event was not captured in the C-SSRS suicidal behaviour count as the participant\'s responses to suicidal ideation/behaviours were "no" for all completed assessments.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Galcanezumab 300 mg SC', 'description': 'Participants received 300 mg Galcanezumab administered SC up to once a month.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through End of Study (Up to 4 Years)', 'description': 'A TEAE is defined as the reported AEs that first occurred or worsened during the post-baseline phase compared with the baseline phase.\n\nAn SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. A summary of serious and other non-serious adverse events regardless of causality is located in the reported adverse events module.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Galcanezumab 300 mg SC', 'description': 'Participants received 300 mg Galcanezumab administered SC up to once a month.'}], 'classes': [{'title': 'Suicidal Ideation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Suicidal Behaviour', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through End of Study (Up to 4 Years)', 'description': 'C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no).\n\n* Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent.\n* Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: Preparatory Acts or Behaviour, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had at least one postbaseline C-SSRS assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Galcanezumab 300 mg SC', 'description': 'Participants received 300 mg Galcanezumab administered SC up to once a month.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through End of Study (Up to 4 Years)', 'description': 'A participant is considered TE-ADA positive if:\n\n* ADA "not present" baseline result and any subsequent "present" postbaseline ADA result with a titer of at least 1:20 (treatment-induced), or\n* ADA "present" baseline result and any subsequent "present" postbaseline ADA result with a 4-fold or greater increase in titer from baseline (treatment-boosted).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had baseline and at least one post baseline ADA assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Galcanezumab 300 mg SC', 'description': 'Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}]}, {'type': 'COMPLETED', 'comment': 'Participants who continued until sponsor ended the study following regulatory approval or non-approval of study drug for cluster headache indication in a country/region.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'Participants who completed one of the parent studies I5Q-MC-CGAL (NCT02397473) or I5Q-MC-CGAM (NCT02438826) were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Galcanezumab 300 mg SC', 'description': 'Participants received 300 mg Galcanezumab administered SC up to once a month.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.30', 'spread': '9.76', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '123', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '117', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '140', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-15', 'size': 652415, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-04T03:45', 'hasProtocol': True}, {'date': '2021-03-02', 'size': 3576616, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-04T03:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-20', 'studyFirstSubmitDate': '2016-06-09', 'resultsFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-20', 'studyFirstPostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)', 'timeFrame': 'Baseline through End of Study (Up to 4 Years)', 'description': 'A TEAE is defined as the reported AEs that first occurred or worsened during the post-baseline phase compared with the baseline phase.\n\nAn SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. A summary of serious and other non-serious adverse events regardless of causality is located in the reported adverse events module.'}, {'measure': 'Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline through End of Study (Up to 4 Years)', 'description': 'C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no).\n\n* Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent.\n* Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: Preparatory Acts or Behaviour, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab', 'timeFrame': 'Baseline through End of Study (Up to 4 Years)', 'description': 'A participant is considered TE-ADA positive if:\n\n* ADA "not present" baseline result and any subsequent "present" postbaseline ADA result with a titer of at least 1:20 (treatment-induced), or\n* ADA "present" baseline result and any subsequent "present" postbaseline ADA result with a 4-fold or greater increase in titer from baseline (treatment-boosted).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cluster headache', 'headache', 'brain diseases', 'central nervous system diseases', 'headache disorders', 'headache disorders, primary', 'nervous system diseases', 'neurologic manifestations', 'pain', 'trigeminal autonomic cephalalgias'], 'conditions': ['Episodic Cluster Headache', 'Chronic Cluster Headache']}, 'referencesModule': {'references': [{'pmid': '35633025', 'type': 'DERIVED', 'citation': 'Riesenberg R, Gaul C, Stroud CE, Dong Y, Bangs ME, Wenzel R, Martinez JM, Oakes TM. Long-term open-label safety study of galcanezumab in patients with episodic or chronic cluster headache. Cephalalgia. 2022 Oct;42(11-12):1225-1235. doi: 10.1177/03331024221103509. Epub 2022 May 27.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/WEzAu0Rzqgg2YY8AKeKSC', 'label': 'A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the long-term safety and tolerability of galcanezumab administered up to once monthly in participants with episodic or chronic cluster headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM (NCT02438826).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who participated in and completed either study CGAL or study CGAM.\n* Investigator judges the participant as reliable to follow all study procedures, keep all study visits, and be compliant with study requirements.\n\nExclusion Criteria:\n\n* Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device (with the exception of Study CGAL or Study CGAM).\n* Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF) (with the exception of Study CGAL or Study CGAM).\n* A history of migraine variants that could implicate or could be confused with ischemia.\n* Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins.\n* A history or presence of other medical illness that indicates a medical problem that would preclude study participation.\n* Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator.\n* Women who are pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT02797951', 'briefTitle': 'A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache', 'orgStudyIdInfo': {'id': '16351'}, 'secondaryIdInfos': [{'id': 'I5Q-MC-CGAR', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2015-005234-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Galcanezumab', 'description': 'Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month.', 'interventionNames': ['Drug: Galcanezumab']}], 'interventions': [{'name': 'Galcanezumab', 'type': 'DRUG', 'otherNames': ['LY2951742'], 'description': 'Administered SC', 'armGroupLabels': ['Galcanezumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Hospital', 'geoPoint': {'lat': 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'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center of Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Head, Pain and Neurological Institute', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Trials of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '98007-4209', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Clinical Research Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': 'B-9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 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