Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT03055767
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2017-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Study in the Pediatric Pain Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}}}}, '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': 'D012965', 'term': 'Sodium Chloride'}], '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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ssshah1@hs.uci.edu', 'phone': '(949) 824-7246', 'title': 'Shalini Shah, MD', 'organization': 'University of California, Irvine | Dept. of Anesthesiology & Perioperative Care'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "A lack of diversity in subject demographics and age. Didn't control for patients seeking alternative therapies during the study period, nor attempt to control concomitant medications.\n\nPatients with comorbidities can have an impact on the treatment effect. PedMIDAS may not account for seasonal changes or patients with modified school schedules.\n\nContinuation of baseline therapy is a confounding variable. Pain diary records required follow-up. Data collection relied in part on subject recall."}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Cross-over: OnabotulinumtoxinA/Saline Placebo', 'description': 'The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second. Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study.\n\nRandomization will be via selection of sealed envelope.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cross-over: Saline Placebo/OnabotulinumtoxinA', 'description': 'The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Off Label Botox:', 'description': 'Following unblinding, subject elected Botox treatment for 24 week open-label period where all subjects receive Botox treatment.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Off Label Standard of Care:', 'description': 'Following unblinding, subject elected to a 24-week return to conservative management per standard-of-care protocols.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of Migraines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Period | Control', 'description': '4-Week baseline period prior to injection procedures.'}, {'id': 'OG001', 'title': 'Botox Period', 'description': '12-Week period where subject receives onabotulinumtoxinA'}, {'id': 'OG002', 'title': 'Placebo Period', 'description': '12-week period where subject receives placebo injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '28'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '28'}, {'value': '28', 'groupId': 'OG002', 'lowerLimit': '23', 'upperLimit': '28'}]}]}], 'analyses': [{'pValue': '0.038', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'The frequency of migraines in days.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intensity of Migraines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Period | Control', 'description': '4-Week baseline period prior to injection procedures.'}, {'id': 'OG001', 'title': 'Botox Period', 'description': '12-Week period where subject receives onabotulinumtoxinA'}, {'id': 'OG002', 'title': 'Placebo Period', 'description': '12-week period where subject receives placebo injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '7'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Wilcoxon signed-rank test)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'Median intensity of migraines based on 0-10 Pain Numeric Rating Score (NRS). The higher the score, the more intense the pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Migraine Duration, in Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Period | Control', 'description': '4-Week baseline period prior to injection procedures.'}, {'id': 'OG001', 'title': 'Botox Period', 'description': '12-Week period where subject receives onabotulinumtoxinA'}, {'id': 'OG002', 'title': 'Placebo Period', 'description': '12-week period where subject receives placebo injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '24'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '24'}, {'value': '24', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '24'}]}]}], 'analyses': [{'pValue': '0.148', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Wilcoxon signed-rank test)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'Duration of migraines in hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pediatric Migraine Disability Score (PedMIDAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Period | Control', 'description': '4-Week baseline period prior to injection procedures.'}, {'id': 'OG001', 'title': 'Botox Period', 'description': '12-Week period where subject receives onabotulinumtoxinA'}, {'id': 'OG002', 'title': 'Placebo Period', 'description': '12-week period where subject receives placebo injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '4'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Wilcoxon signed-rank test)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': "Pediatric Migraine Disability Score consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months.\n\nThe questionnaire produces a raw score (0-10, 11-30, 31-50, \\>50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Functionality Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botox Period', 'description': '12-Week period where subject receives onabotulinumtoxinA'}, {'id': 'OG001', 'title': 'Placebo Period', 'description': '12-week period where subject receives placebo injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon signed-rank test)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': "Improvement of functionality as determined by their Pediatric Migraine Disability Score (PedMIDAS). The PedMIDAS consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months.\n\nThe questionnaire produces a raw score (0-10, 11-30, 31-50, \\>50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline acted as control so no data for Functionality Improvement collected from participants at baseline.'}, {'type': 'SECONDARY', 'title': 'Difficulty Sleeping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Period | Control', 'description': '4-Week baseline period prior to injection procedures.'}, {'id': 'OG001', 'title': 'Botox Period', 'description': '12-Week period where subject receives onabotulinumtoxinA'}, {'id': 'OG002', 'title': 'Placebo Period', 'description': '12-week period where subject receives placebo injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'Subject reported having difficulty sleeping', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Period | Control', 'description': '4-Week baseline period prior to injection procedures.'}, {'id': 'OG001', 'title': 'Botox Period', 'description': '12-Week period where subject receives onabotulinumtoxinA'}, {'id': 'OG002', 'title': 'Placebo Period', 'description': '12-week period where subject receives placebo injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'Admission to hospital', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Emergency Department (ED) Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Period | Control', 'description': '4-Week baseline period prior to injection procedures.'}, {'id': 'OG001', 'title': 'Botox Period', 'description': '12-Week period where subject receives onabotulinumtoxinA'}, {'id': 'OG002', 'title': 'Placebo Period', 'description': '12-week period where subject receives placebo injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.039', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'Subject visited an Emergency Department', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Home School', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Period | Control', 'description': '4-Week baseline period prior to injection procedures.'}, {'id': 'OG001', 'title': 'Botox Period', 'description': '12-Week period where subject receives onabotulinumtoxinA'}, {'id': 'OG002', 'title': 'Placebo Period', 'description': '12-week period where subject receives placebo injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post, respective intervention', 'description': 'Subject is home schooled full-time.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'School Plan Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Period | Control', 'description': '4-Week baseline period prior to injection procedures.'}, {'id': 'OG001', 'title': 'Botox Period', 'description': '12-Week period where subject receives onabotulinumtoxinA'}, {'id': 'OG002', 'title': 'Placebo Period', 'description': '12-week period where subject receives placebo injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'Subject is enrolled in a school plan such as IEP, 504 plan, or similar modified school schedule.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Benefit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botox Period', 'description': '12-Week period where subject receives onabotulinumtoxinA'}, {'id': 'OG001', 'title': 'Placebo Period', 'description': '12-week period where subject receives placebo injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon signed-rank test)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'The duration of benefit in weeks', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected from participants at 4-week baseline in order to act as the control.'}, {'type': 'SECONDARY', 'title': 'Concomitant Headache Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Period | Control', 'description': '4-Week baseline period prior to injection procedures.'}, {'id': 'OG001', 'title': 'Botox Period', 'description': '12-Week period where subject receives onabotulinumtoxinA'}, {'id': 'OG002', 'title': 'Placebo Period', 'description': '12-week period where subject receives placebo injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Wilcoxon signed-rank test)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'Number of concomitant headache medications taken', 'unitOfMeasure': 'number taken', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Frequency of Migraines | Open-label Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Period | Standard-of-Care', 'description': 'Subjects unblinded and elected to continue with standard care pain consultation (conservative management).'}, {'id': 'OG001', 'title': 'Open-Label Period | Botox Continued', 'description': 'Subjects unblinded and elected to continue with 2 additional rounds of onabotulinumtoxinA.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '28'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24-48 weeks post-baseline period', 'description': 'The frequency of migraines during the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '15 subjects completed the cross-over period. Of those 15, 11 continued Botox (2 lost to follow-up), and 4 elected conservative management (1 discontinued intervention)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intensity of Migraines | Open-Label Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cross-Over Period', 'description': '24-week double-blind period where subjects were randomized into Group A (Botox cross-over to Placebo) or Group B (Placebo cross-over to Botox)'}, {'id': 'OG001', 'title': 'Open-Label Period | Botox Continued', 'description': 'Subjects unblinded and elected to continue with 2 additional rounds of onabotulinumtoxinA.'}, {'id': 'OG002', 'title': 'Open-Label Period | Standard-of-Care', 'description': 'Subjects unblinded and elected to continue with standard care pain consultation (conservative management).'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24-48 weeks post-baseline period', 'description': 'Intensity of migraines during the the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period.\n\nIntensity based on 0-10 Pain Numeric Rating Score (NRS). The higher the score, the more intense the pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '15 subjects completed the cross-over period. Of those 15, 11 continued Botox (2 lost to follow-up), and 4 elected conservative management (1 discontinued intervention)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pediatric Migraine Disability Score (PedMIDAS) | Open-Label Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cross-Over Period', 'description': '24-week double-blind period where subjects were randomized into Group A (Botox cross-over to Placebo) or Group B (Placebo cross-over to Botox)'}, {'id': 'OG001', 'title': 'Open-Label Period | Botox Continued', 'description': 'Subjects unblinded and elected to continue with 2 additional rounds of onabotulinumtoxinA.'}, {'id': 'OG002', 'title': 'Open-Label Period | Standard-of-Care', 'description': 'Subjects unblinded and elected to continue with standard care pain consultation (conservative management).'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24-48 weeks post-baseline period', 'description': "The PedMIDAS the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period.\n\nThe PedMIDAS consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months.\n\nThe questionnaire produces a raw score (0-10, 11-30, 31-50, \\>50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'After the unblinding visit, 11 subjects elected to continue with the open-label period and were scheduled to receive two additional rounds of OBTA treatment (2 were lost to follow up). 4 subjects elected to receive standard of care (1 discontinued intervention).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of Migraine | Open-Label Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cross-Over Period', 'description': '24-week double-blind period where subjects were randomized into Group A (Botox cross-over to Placebo) or Group B (Placebo cross-over to Botox)'}, {'id': 'OG001', 'title': 'Open-Label Period | Botox Continued', 'description': 'Subjects unblinded and elected to continue with 2 additional rounds of onabotulinumtoxinA.'}, {'id': 'OG002', 'title': 'Open-Label Period | Standard-of-Care', 'description': 'Subjects unblinded and elected to continue with standard care pain consultation (conservative management).'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '24'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '14'}, {'value': '24', 'groupId': 'OG002', 'lowerLimit': '24', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24-48 weeks post-baseline period', 'description': 'Duration of migraine in hours during the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'After the unblinding visit, 11 subjects elected to continue with the open-label period and were scheduled to receive two additional rounds of OBTA treatment (2 were lost to follow up). 4 subjects elected to receive standard of care (1 discontinued intervention).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cross-over: OnabotulinumtoxinA, Then Saline Placebo', 'description': 'The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second. Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.'}, {'id': 'FG001', 'title': 'Cross-over: Saline Placebo, Then OnabotulinumtoxinA', 'description': 'The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.'}, {'id': 'FG002', 'title': 'Open Label Botox', 'description': 'Following unblinding, subject elected Botox treatment for 24 week open-label period where all subjects receive Botox treatment.'}, {'id': 'FG003', 'title': 'Open Label Standard of Care', 'description': 'Following unblinding, subject elected to a 24-week return to conservative management per standard-of-care protocols.'}], 'periods': [{'title': 'Double-Blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "Pediatric subjects aged 8 to 17 were recruited during an enrollment window from March 1st, 2017 to November 30th, 2018 at the UCI Health Center for Pain and Wellness located at UCI Health's Gottschalk Medical Plaza."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cross-Over: OnabotulinumtoxinA, Then Saline Placebo', 'description': 'The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.\n\nOnabotulinumtoxinA: The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.\n\nPlacebo (Saline): The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.'}, {'id': 'BG001', 'title': 'Cross-Over: Saline Placebo, Then OnabotulinumtoxinA', 'description': 'The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.\n\nOnabotulinumtoxinA: The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.\n\nPlacebo (Saline): The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '15 subjects randomized into the baseline, double-blind period (cross-over).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-20', 'size': 2535190, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-31T16:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2017-02-08', 'resultsFirstSubmitDate': '2023-06-02', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-22', 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Frequency of Migraines | Open-label Period', 'timeFrame': '24-48 weeks post-baseline period', 'description': 'The frequency of migraines during the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period.'}, {'measure': 'Intensity of Migraines | Open-Label Period', 'timeFrame': '24-48 weeks post-baseline period', 'description': 'Intensity of migraines during the the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period.\n\nIntensity based on 0-10 Pain Numeric Rating Score (NRS). The higher the score, the more intense the pain.'}, {'measure': 'Pediatric Migraine Disability Score (PedMIDAS) | Open-Label Period', 'timeFrame': '24-48 weeks post-baseline period', 'description': "The PedMIDAS the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period.\n\nThe PedMIDAS consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months.\n\nThe questionnaire produces a raw score (0-10, 11-30, 31-50, \\>50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4)."}, {'measure': 'Duration of Migraine | Open-Label Period', 'timeFrame': '24-48 weeks post-baseline period', 'description': 'Duration of migraine in hours during the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period.'}], 'primaryOutcomes': [{'measure': 'Frequency of Migraines', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'The frequency of migraines in days.'}, {'measure': 'Intensity of Migraines', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'Median intensity of migraines based on 0-10 Pain Numeric Rating Score (NRS). The higher the score, the more intense the pain.'}, {'measure': 'Migraine Duration, in Hours', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'Duration of migraines in hours.'}, {'measure': 'Pediatric Migraine Disability Score (PedMIDAS)', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': "Pediatric Migraine Disability Score consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months.\n\nThe questionnaire produces a raw score (0-10, 11-30, 31-50, \\>50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4)."}], 'secondaryOutcomes': [{'measure': 'Functionality Improvement', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': "Improvement of functionality as determined by their Pediatric Migraine Disability Score (PedMIDAS). The PedMIDAS consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months.\n\nThe questionnaire produces a raw score (0-10, 11-30, 31-50, \\>50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4)."}, {'measure': 'Difficulty Sleeping', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'Subject reported having difficulty sleeping'}, {'measure': 'Hospital Admissions', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'Admission to hospital'}, {'measure': 'Emergency Department (ED) Visits', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'Subject visited an Emergency Department'}, {'measure': 'Home School', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post, respective intervention', 'description': 'Subject is home schooled full-time.'}, {'measure': 'School Plan Enrollment', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'Subject is enrolled in a school plan such as IEP, 504 plan, or similar modified school schedule.'}, {'measure': 'Duration of Benefit', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'The duration of benefit in weeks'}, {'measure': 'Concomitant Headache Medications', 'timeFrame': 'Baseline (4 weeks) and 12 weeks post each, respective intervention', 'description': 'Number of concomitant headache medications taken'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine Disorders', 'Headache, Migraine', 'Pediatrics']}, 'referencesModule': {'references': [{'pmid': '21883197', 'type': 'BACKGROUND', 'citation': 'Aurora SK, Winner P, Freeman MC, Spierings EL, Heiring JO, DeGryse RE, VanDenburgh AM, Nolan ME, Turkel CC. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011 Oct;51(9):1358-73. doi: 10.1111/j.1526-4610.2011.01990.x. Epub 2011 Aug 29.'}, {'pmid': '20487038', 'type': 'BACKGROUND', 'citation': 'Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF; PREEMPT Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010 Jun;50(6):921-36. doi: 10.1111/j.1526-4610.2010.01678.x. Epub 2010 May 7.'}, {'pmid': '20933173', 'type': 'BACKGROUND', 'citation': 'Ahmed K, Oas KH, Mack KJ, Garza I. Experience with botulinum toxin type A in medically intractable pediatric chronic daily headache. Pediatr Neurol. 2010 Nov;43(5):316-9. doi: 10.1016/j.pediatrneurol.2010.06.001.'}, {'pmid': '23303551', 'type': 'BACKGROUND', 'citation': 'Bonfert M, Straube A, Schroeder AS, Reilich P, Ebinger F, Heinen F. Primary headache in children and adolescents: update on pharmacotherapy of migraine and tension-type headache. Neuropediatrics. 2013 Feb;44(1):3-19. doi: 10.1055/s-0032-1330856. Epub 2013 Jan 9.'}, {'pmid': '26521123', 'type': 'BACKGROUND', 'citation': 'Brodsky JR, Cusick BA, Zhou G. Evaluation and management of vestibular migraine in children: Experience from a pediatric vestibular clinic. Eur J Paediatr Neurol. 2016 Jan;20(1):85-92. doi: 10.1016/j.ejpn.2015.09.011. Epub 2015 Oct 22.'}, {'pmid': '19835236', 'type': 'BACKGROUND', 'citation': 'Chan VW, McCabe EJ, MacGregor DL. Botox treatment for migraine and chronic daily headache in adolescents. J Neurosci Nurs. 2009 Oct;41(5):235-43. doi: 10.1097/jnn.0b013e3181aaa98f.'}, {'pmid': '7596620', 'type': 'BACKGROUND', 'citation': 'Hermann C, Kim M, Blanchard EB. Behavioral and prophylactic pharmacological intervention studies of pediatric migraine: an exploratory meta-analysis. Pain. 1995 Mar;60(3):239-55. doi: 10.1016/0304-3959(94)00210-6.'}, {'pmid': '23594025', 'type': 'BACKGROUND', 'citation': 'Hershey AD, Powers SW, Coffey CS, Eklund DD, Chamberlin LA, Korbee LL; CHAMP Study Group. Childhood and Adolescent Migraine Prevention (CHAMP) study: a double-blinded, placebo-controlled, comparative effectiveness study of amitriptyline, topiramate, and placebo in the prevention of childhood and adolescent migraine. Headache. 2013 May;53(5):799-816. doi: 10.1111/head.12105. Epub 2013 Apr 17.'}, {'pmid': '22288433', 'type': 'BACKGROUND', 'citation': 'Jacobs H, Gladstein J. Pediatric headache: a clinical review. Headache. 2012 Feb;52(2):333-9. doi: 10.1111/j.1526-4610.2011.02086.x. Epub 2012 Jan 30.'}, {'pmid': '22274570', 'type': 'BACKGROUND', 'citation': "Kabbouche M, O'Brien H, Hershey AD. OnabotulinumtoxinA in pediatric chronic daily headache. Curr Neurol Neurosci Rep. 2012 Apr;12(2):114-7. doi: 10.1007/s11910-012-0251-1."}, {'pmid': '24760491', 'type': 'BACKGROUND', 'citation': 'Kacperski J, Hershey AD. Preventive drugs in childhood and adolescent migraine. Curr Pain Headache Rep. 2014 Jun;18(6):422. doi: 10.1007/s11916-014-0422-7.'}, {'pmid': '25772998', 'type': 'BACKGROUND', 'citation': 'Yonker M, Mangum T. Migraine management in children. Curr Neurol Neurosci Rep. 2015 May;15(5):20. doi: 10.1007/s11910-015-0540-6.'}, {'pmid': '26695061', 'type': 'BACKGROUND', 'citation': 'Tajti J, Szok D, Csati A, Vecsei L. Prophylactic Drug Treatment of Migraine in Children and Adolescents: An Update. Curr Pain Headache Rep. 2016 Jan;20(1):1. doi: 10.1007/s11916-015-0536-6.'}, {'pmid': '33106278', 'type': 'DERIVED', 'citation': 'Shah S, Calderon MD, Crain N, Pham J, Rinehart J. Effectiveness of onabotulinumtoxinA (BOTOX) in pediatric patients experiencing migraines: a randomized, double-blinded, placebo-controlled crossover study in the pediatric pain population. Reg Anesth Pain Med. 2021 Jan;46(1):41-48. doi: 10.1136/rapm-2020-101605. Epub 2020 Oct 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the research is to examine the outcomes of pediatric patients receiving Botulinum toxin type A (Botox ®) for the treatment of migraine. There is limited literature on the effectiveness of Botox ® in the treatment of chronic neurological pain in pediatric patients, specifically in the treatment of migraines.', 'detailedDescription': "Medical Literature approximates one in three children will experience chronic headaches in their lifetime, which increases as children reach adolescence. Migraines make up nearly 60% of all visits to a pediatric headache specialist. Studies have demonstrated the negative impact of having childhood migraine on overall quality of life is similar to pediatric cancer, heart disease and rheumatic disease. As the frequency of migraine attacks increase, so does proportionally the child's disability in lost school time and family and social interactions, all of which may lead in turn to economic disability. Studies estimate the health care costs are 70% higher for a family with a migraine than a non-migraine affected family, and direct medical costs for children with migraine are reported to be similar to those for adults. A study published in JAMA 2003 found that health care costs, work-related disability for parents and lost educational opportunity for the child leads to an annual economic impact in the US of approximately $36 billion due to both direct medical costs and lost productivity into adulthood.\n\nOnaboutlinum (BOTOX) is currently FDA approved as a very successful treatment to prevent migraines in adults, however not yet children. Current treatments for migraine in children appear to be insufficient. No trials currently exist in literature prospectively studying onabotulinumtoxinA for efficacy and/or safety for indication of pediatric migraine, although significant contributions have been made by retrospective case series over the last 10 years.\n\nThis research will be the first investigator-initiated study to study BOTOX (R) in children prospectively in a randomized controlled placebo, cross-over study. The overriding rationale is to demonstrate efficacy, tolerability and safety of onabotulinumtoxinA for pediatric migraine and thereby potentially hasten the lengthy process to evaluate BOTOX® for approval in the pediatric population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 8 - 17 years of age with a history of migraine meeting the criteria established in ICHD-II (2004), Section 1. Patients will provide at least 28-day baseline data in the form in the daily diary and must have at least 15 days of reported headache during this period, with at least 4 distinct episodes lasting at least 4 hours each.\n\nExclusion Criteria:\n\n* Previous use of botulinum toxin of any serotype for any reason\n* Pregnancy.\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 of screening visit'}, 'identificationModule': {'nctId': 'NCT03055767', 'briefTitle': 'Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Study in the Pediatric Pain Population', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Randomized Double Blinded Placebo Cross-over Study in the Pediatric Pain Population', 'orgStudyIdInfo': {'id': '20163108'}, 'secondaryIdInfos': [{'id': 'UCIANES09', 'type': 'OTHER', 'domain': 'University of California, Irvine'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'OnabotulinumtoxinA/Saline Placebo', 'description': 'The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.', 'interventionNames': ['Drug: OnabotulinumtoxinA', 'Other: Placebo (Saline)']}, {'type': 'OTHER', 'label': 'Saline Placebo/OnabotulinumtoxinA', 'description': 'The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.', 'interventionNames': ['Drug: OnabotulinumtoxinA', 'Other: Placebo (Saline)']}], 'interventions': [{'name': 'OnabotulinumtoxinA', 'type': 'DRUG', 'otherNames': ['Botox'], 'description': 'The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.', 'armGroupLabels': ['OnabotulinumtoxinA/Saline Placebo', 'Saline Placebo/OnabotulinumtoxinA']}, {'name': 'Placebo (Saline)', 'type': 'OTHER', 'description': 'The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.', 'armGroupLabels': ['OnabotulinumtoxinA/Saline Placebo', 'Saline Placebo/OnabotulinumtoxinA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Gottschalk Medical Plaza', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'Shalini S Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Clinical Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Society of Regional Anesthesia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Chair, Pain Management', 'investigatorFullName': 'Shalini Suresh Shah', 'investigatorAffiliation': 'University of California, Irvine'}}}}