Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT02147561
Status:
COMPLETED
Last Update Posted:
2016-05-27
First Post:
2014-05-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs). The Safety Population included patients enrolled in the study who received study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Botulinum Toxin Type A', 'description': 'Botulinum toxin Type A injected across specific head and neck muscles on Day 0.', 'otherNumAtRisk': 279, 'otherNumAffected': 38, 'seriousNumAtRisk': 279, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Muscle Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'Ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}], 'seriousEvents': [{'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'Common Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'Botulinum toxin Type A injected across specific head and neck muscles on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.37', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 Days', 'description': 'An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: patients enrolled in the study who received study drug'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'Botulinum toxin Type A injected across specific head and neck muscles on Day 0.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '67.54', 'spread': '5.83', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Day 28', 'categories': [{'measurements': [{'value': '-7.32', 'spread': '7.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Physician Global Assessment of Outcome on a 3-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'Botulinum toxin Type A injected across specific head and neck muscles on Day 0.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 28', 'description': 'Physicians evaluated patient migraines as improved, no change, or worse compared to baseline.', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Botulinum Toxin Type A', 'description': 'Botulinum toxin Type A injected across specific head and neck muscles on Day 0.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '280'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '276'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': "Subjects who didn't receive BOTOX", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Botulinum Toxin Type A', 'description': 'Botulinum toxin Type A injected across specific head and neck muscles on Day 0.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.81', 'spread': '14.56', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '229', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Population included patients enrolled in the study who received study drug. The Safety Population was used to assess the baseline characteristics.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-22', 'studyFirstSubmitDate': '2014-05-22', 'resultsFirstSubmitDate': '2016-03-09', 'studyFirstSubmitQcDate': '2014-05-22', 'lastUpdatePostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-22', 'studyFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Adverse Events', 'timeFrame': '28 Days', 'description': 'An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score', 'timeFrame': 'Baseline, Day 28', 'description': 'The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.'}, {'measure': 'Physician Global Assessment of Outcome on a 3-Point Scale', 'timeFrame': 'Baseline, Day 28', 'description': 'Physicians evaluated patient migraines as improved, no change, or worse compared to baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Migraine Disorders']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with chronic migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ethnically Korean with a diagnosis of chronic migraine\n\nExclusion Criteria:\n\n* Anticipated need for botulinum toxin treatment for any reason other than chronic migraine during the study\n* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis'}, 'identificationModule': {'nctId': 'NCT02147561', 'briefTitle': 'A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '191622-148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'botulinum toxin Type A', 'description': 'Botulinum toxin Type A injected across specific head and neck muscles on Day 0.', 'interventionNames': ['Biological: botulinum toxin Type A']}], 'interventions': [{'name': 'botulinum toxin Type A', 'type': 'BIOLOGICAL', 'otherNames': ['BOTOX®', 'onabotulinumtoxinA'], 'description': 'Botulinum toxin Type A injected across specific head and neck muscles on Day 0.', 'armGroupLabels': ['botulinum toxin Type A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}