Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-02-18 @ 5:39 PM
Study NCT ID:
NCT01662492
Status:
COMPLETED
Last Update Posted:
2017-09-05
First Post:
2012-08-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents 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'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, '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': {'timeFrame': 'Up to Week 12', 'eventGroups': [{'id': 'EG000', 'title': 'Botulinum Toxin Type A 155 U', 'description': 'Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.', 'otherNumAtRisk': 43, 'otherNumAffected': 8, 'seriousNumAtRisk': 43, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Botulinum Toxin Type A 74 U', 'description': 'Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.', 'otherNumAtRisk': 43, 'otherNumAffected': 14, 'seriousNumAtRisk': 43, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) intramuscular injections into specified muscles.', 'otherNumAtRisk': 37, 'otherNumAffected': 8, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 19.0'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 19.0'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 19.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 19.0'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 19.0'}], 'seriousEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 19.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 19.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Frequency of Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A 155 U', 'description': 'Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A 74 U', 'description': 'Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.'}, {'id': 'OG002', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) intramuscular injections into specified muscles.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '23.2', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '25.3', 'spread': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 12', 'categories': [{'measurements': [{'value': '-6.3', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '-6.8', 'spread': '8.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.', 'unitOfMeasure': 'Headache days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Frequency of Severe Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A 155 U', 'description': 'Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A 74 U', 'description': 'Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.'}, {'id': 'OG002', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) intramuscular injections into specified muscles.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.0', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '9.1', 'spread': '8.3', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 12', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '7.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 Weeks', 'description': "Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary.", 'unitOfMeasure': 'Severe Headache Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Total Cumulative Hours of Headache on Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A 155 U', 'description': 'Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A 74 U', 'description': 'Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.'}, {'id': 'OG002', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) intramuscular injections into specified muscles.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '170.69', 'spread': '151.60', 'groupId': 'OG000'}, {'value': '175.98', 'spread': '139.76', 'groupId': 'OG001'}, {'value': '212.68', 'spread': '184.37', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 12', 'categories': [{'measurements': [{'value': '-36.52', 'spread': '53.19', 'groupId': 'OG000'}, {'value': '-19.03', 'spread': '113.73', 'groupId': 'OG001'}, {'value': '-50.04', 'spread': '87.36', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days.', 'unitOfMeasure': 'Cumulative hours of headache', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A 155 U', 'description': 'Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A 74 U', 'description': 'Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.'}, {'id': 'OG002', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) intramuscular injections into specified muscles.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '32.6', 'groupId': 'OG001'}, {'value': '29.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A 155 U', 'description': 'Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A 74 U', 'description': 'Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.'}, {'id': 'OG002', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) intramuscular injections into specified muscles.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Weeks', 'description': 'Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: All randomized subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Botulinum Toxin Type A 155 U', 'description': 'Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.'}, {'id': 'FG001', 'title': 'Botulinum Toxin Type A 74 U', 'description': 'Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.'}, {'id': 'FG002', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) intramuscular injections into specified muscles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Other miscellaneous reasons.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Botulinum Toxin Type A 155 U', 'description': 'Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.'}, {'id': 'BG001', 'title': 'Botulinum Toxin Type A 74 U', 'description': 'Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.'}, {'id': 'BG002', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) intramuscular injections into specified muscles.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '15.0', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '15.2', 'spread': '1.5', 'groupId': 'BG002'}, {'value': '15.1', 'spread': '1.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-03', 'studyFirstSubmitDate': '2012-08-08', 'resultsFirstSubmitDate': '2017-08-03', 'studyFirstSubmitQcDate': '2012-08-08', 'lastUpdatePostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-03', 'studyFirstPostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Frequency of Headache Days', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Frequency of Severe Headache Days', 'timeFrame': 'Baseline, 12 Weeks', 'description': "Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary."}, {'measure': 'Change From Baseline in the Total Cumulative Hours of Headache on Headache Days', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days.'}, {'measure': 'Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days.'}, {'measure': 'Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment', 'timeFrame': '12 Weeks', 'description': 'Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Migraine Disorders']}, 'referencesModule': {'references': [{'pmid': '29877131', 'type': 'DERIVED', 'citation': 'Shah S, Calderon MD, Wu W, Grant J, Rinehart J. Onabotulinumtoxin A (BOTOX(R)) for ProphylaCTIC Treatment of Pediatric Migraine: A Retrospective Longitudinal Analysis. J Child Neurol. 2018 Aug;33(9):580-586. doi: 10.1177/0883073818776142. Epub 2018 Jun 7.'}], 'seeAlsoLinks': [{'url': 'http://www.allerganclinicaltrials.com', 'label': 'More Information'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical history of chronic migraine for at least 6 months\n* 15 or more headache days during a 4 week period\n\nExclusion Criteria:\n\n* Previous use of any botulinum toxin of any serotype for any reason\n* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis\n* Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks prior to the week -4 screening visit\n* Use of any headache prophylaxis medication within 4 weeks prior to the week -4 screening visit'}, 'identificationModule': {'nctId': 'NCT01662492', 'briefTitle': 'A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': '191622-103 BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Headache Prophylaxis in Adolescents (Children 12 to < 18 Years of Age) With Chronic Migraine', 'orgStudyIdInfo': {'id': '191622-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botulinum toxin type A Dose 1', 'description': 'Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.', 'interventionNames': ['Biological: Botulinum toxin type A Dose 1']}, {'type': 'EXPERIMENTAL', 'label': 'Botulinum toxin type A Dose 2', 'description': 'Botulinum toxin type A Dose 2 intramuscular injections 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