Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-30 @ 2:16 AM
Study NCT ID:
NCT04458857
Status:
COMPLETED
Last Update Posted:
2025-06-22
First Post:
2020-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-14', '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': 'C000604315', 'term': 'fremanezumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'USMedInfo@tevapharm.com', 'phone': '888-483-8279', 'title': 'Director, Clinical Research', 'organization': 'Teva Branded Pharmaceutical Products, R&D Inc.'}, 'certainAgreement': {'otherDetails': "Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Month 3', 'description': 'The safety analysis set included all randomized participants who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).', 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 26, 'seriousNumAtRisk': 112, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Fremanezumab Dose A', 'description': 'Participants weighing \\<threshold weight received fremanezumab SC at dose A for 3 months (Days 1, 29, and 57).', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 8, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Fremanezumab Dose B', 'description': 'Participants weighing ≥threshold weight received fremanezumab SC at dose B for 3 months (Days 1, 29, and 57).', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 29, 'seriousNumAtRisk': 87, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 18, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vaccination site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Immune thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hepatitis infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Monthly Average Number of Migraine Days During 12-Week Period After the First Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'OG001', 'title': 'Fremanezumab', 'description': 'Participants received fremanezumab SC for 3 months (Days 1, 29, and 57).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0210', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.90', 'ciUpperLimit': '-0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -28 to Day -1), up to Week 12', 'description': 'A migraine day was defined as a day with any of the following: A day (0:00 to 23:59) with at least 2 hours of headache with ≥2 migraine symptom(s) or day (0:00 to 23:59) demonstrating a headache treated with migraine medications (e.g., non-steroidal anti-inflammatory drugs \\[NSAIDs\\], paracetamol etc.), or a headache associated with aura. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in electronic diary (e-diary) for 12-week period) \\* 28. Least square (LS) mean was calculated using analysis of covariance (ANCOVA). The full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug and had at least 10 days of diary entries postbaseline for efficacy assessments on primary endpoint. Efficacy analysis was planned to be collected and evaluated combined for both fremanezumab dose treatment groups.', 'unitOfMeasure': 'days/month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug and had at least 10 days of diary entries postbaseline for efficacy assessments on the primary endpoint. Efficacy analysis was planned to be evaluated combined for both fremanezumab dose treatment groups.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'OG001', 'title': 'Fremanezumab Dose A', 'description': 'Participants weighing \\<threshold weight received fremanezumab SC at dose A for 3 months (Days 1, 29, and 57).'}, {'id': 'OG002', 'title': 'Fremanezumab Dose B', 'description': 'Participants weighing ≥threshold weight received fremanezumab SC at dose B for 3 months (Days 1, 29, and 57).'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Month 3', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Shift From Baseline to Last Assessment in Electrocardiogram (ECG) Findings (Assessed by Investigator)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'OG001', 'title': 'Fremanezumab Dose A', 'description': 'Participants weighing \\<threshold weight received fremanezumab SC at dose A for 3 months (Days 1, 29, and 57).'}, {'id': 'OG002', 'title': 'Fremanezumab Dose B', 'description': 'Participants weighing ≥threshold weight received fremanezumab SC at dose B for 3 months (Days 1, 29, and 57).'}], 'classes': [{'categories': [{'title': 'Normal/Normal', 'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}, {'title': 'Abnormal NCS/Normal', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Abnormal CS/Normal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Normal/Abnormal NCS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'Abnormal NCS/Abnormal NCS', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Abnormal CS/Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Normal/Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Abnormal NCS/Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Abnormal CS/Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to last assessment (up to Month 3)', 'description': "The number of participants with a shift from Baseline (Normal, Abnormal CS \\[Clinically Significant\\], or Abnormal NCS \\[Not Clinically Significant\\]) in any of the following ECG parameters is reported by treatment group: Heart rate, PR interval, QRS interval, RR interval, QT interval, QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF). Last assessment was defined as the last observed postbaseline interpretation. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Shift From Baseline to Last Assessment in ECG Findings (Assessed by Cardiologist)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'OG001', 'title': 'Fremanezumab Dose A', 'description': 'Participants weighing \\<threshold weight received fremanezumab SC at dose A for 3 months (Days 1, 29, and 57).'}, {'id': 'OG002', 'title': 'Fremanezumab Dose B', 'description': 'Participants weighing ≥threshold weight received fremanezumab SC at dose B for 3 months (Days 1, 29, and 57).'}], 'classes': [{'categories': [{'title': 'Normal/Normal', 'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}, {'title': 'Abnormal/Normal', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Normal/Abnormal', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Abnormal/Abnormal', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to last assessment (up to Month 3)', 'description': 'The number of participants with a shift from Baseline (Normal or Abnormal) in any of the following ECG parameters is reported by treatment group: Heart rate, PR interval, QRS interval, RR interval, QT interval, QTcB, and QTcF. Last assessment was defined as the last observed postbaseline interpretation. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any One or More Potentially Clinically Significant Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'OG001', 'title': 'Fremanezumab Dose A', 'description': 'Participants weighing \\<threshold weight received fremanezumab SC at dose A for 3 months (Days 1, 29, and 57).'}, {'id': 'OG002', 'title': 'Fremanezumab Dose B', 'description': 'Participants weighing ≥threshold weight received fremanezumab SC at dose B for 3 months (Days 1, 29, and 57).'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Month 3', 'description': 'Potentially clinically significant abnormal vital signs findings included any one of the following: Pulse rate ≥120 beats per minute (bpm) and increase from baseline of ≥15 bpm, or ≤50 bpm and decrease from baseline of ≥15 bpm; Systolic blood pressure ≤85 millimeters of mercury (mmHg) and decrease from baseline of ≥20 mmHg; Diastolic blood pressure ≥100 mmHg and increase from baseline of ≥15 mmHg; Respiratory rate \\<15 breaths/minute. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants with at least one Baseline and post-baseline vital sign assessment."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Significant Abnormal Laboratory (Serum Chemistry, Hematology, Coagulation, and Urinalysis) Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'OG001', 'title': 'Fremanezumab Dose A', 'description': 'Participants weighing \\<threshold weight received fremanezumab SC at dose A for 3 months (Days 1, 29, and 57).'}, {'id': 'OG002', 'title': 'Fremanezumab Dose B', 'description': 'Participants weighing ≥threshold weight received fremanezumab SC at dose B for 3 months (Days 1, 29, and 57).'}], 'classes': [{'title': 'With at least 1 serum chemistry abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'With at least 1 hematology abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'With at least 1 coagulation abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'With at least 1 urinalysis abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Month 3', 'description': 'Serum chemistry tests with potentially clinically significant abnormal findings included: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) both ≥2\\*upper limit of normal (ULN); and bilirubin ≥34.2 micromole/liter (umol/L). Hematology tests with potentially clinically significant abnormal findings included: hemoglobin ≤100 grams (g)/L, leukocytes ≤3\\*10\\^9 cells/L, neutrophils ≤1\\*10\\^9 cells/L, eosinophils/leukocytes ≥10%, and platelets ≥700\\*10\\^9 cells/L or ≤75\\*10\\^9 cells/L. Coagulation parameter test with potentially clinically significant abnormal findings included: prothrombin international normalized ratio (INR) \\>1.5. Urinalysis laboratory tests with potentially clinically significant abnormal findings included: urine protein ≥2 units (U) increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' and 'Number analyzed'= participants with at least one Baseline and post-baseline assessment of the specified laboratory parameters."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Physical Examination Findings as Identified by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'OG001', 'title': 'Fremanezumab Dose A', 'description': 'Participants weighing \\<threshold weight received fremanezumab SC at dose A for 3 months (Days 1, 29, and 57).'}, {'id': 'OG002', 'title': 'Fremanezumab Dose B', 'description': 'Participants weighing ≥threshold weight received fremanezumab SC at dose B for 3 months (Days 1, 29, and 57).'}], 'classes': [{'title': 'General Appearance', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'HEENT', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Skin', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Neurological', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Extremities/Back', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Month 3', 'description': 'A complete physical examination included the following organ systems: general appearance; head, eyes, ears, nose, and throat (HEENT); chest and lungs; heart; abdomen; musculoskeletal; skin; lymph nodes; and neurological. Only the organ systems with abnormal physical findings in at least one treatment group have been reported. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants with at least one Baseline and post-baseline physical examination."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'OG001', 'title': 'Fremanezumab Dose A', 'description': 'Participants weighing \\<threshold weight received fremanezumab SC at dose A for 3 months (Days 1, 29, and 57).'}, {'id': 'OG002', 'title': 'Fremanezumab Dose B', 'description': 'Participants weighing ≥threshold weight received fremanezumab SC at dose B for 3 months (Days 1, 29, and 57).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Month 3', 'description': 'C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants with both Baseline and Month 3 assessment."}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During 12-Week Period After the First Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'OG001', 'title': 'Fremanezumab', 'description': 'Participants received fremanezumab SC for 3 months (Days 1, 29, and 57).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -28 to Day -1), up to Week 12', 'description': 'A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the participant reported either of the following: A day with headache pain that lasted ≥2 hours with a peak severity of at least moderate severity or a day where the participant used acute medication (triptans, ergots, NSAIDs or paracetamol) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \\* 28. LS mean was calculated using ANCOVA.', 'unitOfMeasure': 'days/month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of study drug and had at least 10 days of diary entries postbaseline for efficacy assessments on the primary endpoint. Efficacy analysis was planned to be evaluated combined for both fremanezumab dose treatment groups.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reaching at Least 50% Reduction in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'OG001', 'title': 'Fremanezumab', 'description': 'Participants received fremanezumab SC for 3 months (Days 1, 29, and 57).'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day -28 to Day -1) up to Week 12', 'description': 'A migraine day was defined as a calendar day where the participant reported either of the following: A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache that was accompanied by ≥1 migraine symptom(s) or a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (NSAIDs, paracetamol or triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \\* 28.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of study drug and had at least 10 days of diary entries postbaseline for efficacy assessments on the primary endpoint. Efficacy analysis was planned to be evaluated combined for both fremanezumab dose treatment groups.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Monthly Average Number of Days of Use of Any Acute Headache Medications During 12-Week Period After the First Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'OG001', 'title': 'Fremanezumab', 'description': 'Participants received fremanezumab SC for 3 months (Days 1, 29, and 57).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -28 to Day -1), up to Week 12', 'description': 'Participants recorded any headache medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken each day in their electronic headache diary device. Acute headache medication included triptans and ergot compounds, NSAIDs or paracetamol. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \\* 28. LS mean was calculated using ANCOVA.', 'unitOfMeasure': 'days/month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of study drug and had at least 10 days of diary entries postbaseline for efficacy assessments on the primary endpoint. Efficacy analysis was planned to be evaluated combined for both fremanezumab dose treatment groups.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Migraine-related Disability Score at Week 12, as Measured by the Pediatric Migraine Disability Assessment (PedMIDAS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'OG001', 'title': 'Fremanezumab', 'description': 'Participants received fremanezumab SC for 3 months (Days 1, 29, and 57).'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.3', 'spread': '3.37', 'groupId': 'OG000'}, {'value': '-21.6', 'spread': '3.29', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The PedMIDAS is a scale developed to assess headache-related disability which can be self-administered by the participant or administered by a caregiver. It has been validated in participants aged 4 to 18 years and includes 3 subscales: the impact of headache on school performance (range of scores 0-92), disability at home (range of scores 0-92), social/sport functioning (range of scores 0-92). The subscales are added to get the total score with a range 0 to 276. The total score was used for grading of disability, with 4 score categories of 0 to 10, 11 to 30, 31 to 50, and 51-276 interpreted as disability grades 1 (little or no disability), 2 (mild disability), 3 (moderate disability), and 4 (severe disability), respectively. Higher total scores indicated severe disability. LS mean was calculated using ANCOVA. The change from baseline score is reported with a range of -276 to 276 with higher scores indicating more severe disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of study drug and had at least 10 days of diary entries postbaseline for efficacy assessments on the primary endpoint. Efficacy analysis was planned to be evaluated combined for both fremanezumab dose treatment groups.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Quality of Life at Week 12, as Measured by Pediatric Quality of Life Inventory (PedsQL) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'OG001', 'title': 'Fremanezumab', 'description': 'Participants received fremanezumab SC for 3 months (Days 1, 29, and 57).'}], 'classes': [{'title': 'Child-Physical Health Summary Score', 'categories': [{'measurements': [{'value': '8.3', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Child-Psychosocial Health Summary Score', 'categories': [{'measurements': [{'value': '5.3', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': 'Child-Total Scale Score', 'categories': [{'measurements': [{'value': '6.2', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': 'Parent-Physical Health Summary Score', 'categories': [{'measurements': [{'value': '7.3', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '2.35', 'groupId': 'OG001'}]}]}, {'title': 'Parent-Psychosocial Health Summary Score', 'categories': [{'measurements': [{'value': '6.8', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.96', 'groupId': 'OG001'}]}]}, {'title': 'Parent-Total Scale Score', 'categories': [{'measurements': [{'value': '7.2', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '1.97', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'PedsQL 4.0 is a brief 23-item health-related quality of life (QoL) instrument that evaluates QoL in 4 areas of functioning: physical, emotional, social, and school functioning. For child and adolescent self-report (8 - 18 years) and parent report forms, respondents used a 5-point Likert scale to rate item severity (0=never a problem;1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem). For younger children (5 - 7 years), a simplified 3-point Likert scale, anchored with a happy and a sad face, was used (0=not at all a problem; 2=sometimes a problem; 4=a lot of a problem). PedsQL yields a total QoL score and 2 summary scores: Physical Health Summary Score and Psychosocial Health Summary Score. To obtain scores, items were reverse scored, transformed to a 0 through 100 scale (0=100, 1=75, 2=50, 3=25, 4=0), and averaged; total scores near 0 indicated lower QoL, while scores approaching 100 indicated higher QoL. LS mean was calculated using ANCOVA.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of study drug and had at least 10 days of diary entries postbaseline for efficacy assessments on the primary endpoint. Efficacy analysis was planned to be evaluated combined for both fremanezumab dose treatment groups.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Developing Anti-drug Antibodies (ADAs) Throughout the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fremanezumab Dose A', 'description': 'Participants weighing \\<threshold weight received fremanezumab SC at dose A for 3 months (Days 1, 29, and 57).'}, {'id': 'OG001', 'title': 'Fremanezumab Dose B', 'description': 'Participants weighing ≥threshold weight received fremanezumab SC at dose B for 3 months (Days 1, 29, and 57).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Month 3', 'description': 'Number of participants who developed ADAs were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all randomized participants who received at least 1 dose of study drug and had at least 10 days of diary entries postbaseline for efficacy assessments on the primary endpoint. Here, 'Overall number of participants analyzed' = Participants who had Baseline and at least 1 postbaseline ADA assessment."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'FG001', 'title': 'Fremanezumab Dose A', 'description': 'Participants weighing \\<threshold weight received fremanezumab SC at dose A for 3 months (Days 1, 29, and 57).'}, {'id': 'FG002', 'title': 'Fremanezumab Dose B', 'description': 'Participants weighing ≥threshold weight received fremanezumab SC at dose B for 3 months (Days 1, 29, and 57).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '87'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '86'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 411 participants were screened; of which 235 participants were randomized and included in the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '235', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57).'}, {'id': 'BG001', 'title': 'Fremanezumab Dose A', 'description': 'Participants weighing \\<threshold weight received fremanezumab SC at dose A for 3 months (Days 1, 29, and 57).'}, {'id': 'BG002', 'title': 'Fremanezumab Dose B', 'description': 'Participants weighing ≥threshold weight received fremanezumab SC at dose B for 3 months (Days 1, 29, and 57).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '2.99', 'groupId': 'BG000'}, {'value': '11.0', 'spread': '2.27', 'groupId': 'BG001'}, {'value': '14.2', 'spread': '2.34', 'groupId': 'BG002'}, {'value': '13.3', 'spread': '2.86', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '208', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Migraine Days Per Month', 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '2.84', 'groupId': 'BG000'}, {'value': '7.6', 'spread': '2.92', 'groupId': 'BG001'}, {'value': '7.9', 'spread': '3.21', 'groupId': 'BG002'}, {'value': '7.7', 'spread': '2.99', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'A migraine day was defined as a day with either of the following: A day (0:00 to 23:59) with at least 2 hours of headache with ≥2 migraine symptom(s) or day (0:00 to 23:59) demonstrating a headache treated with migraine medications (e.g., non-steroidal anti-inflammatory drugs \\[NSAIDs\\], paracetamol etc.). The number of migraine days during baseline was calculated using headache diary data collected in the run-in period and normalized to a 28-day equivalent using formula: (Total migraine days during run-in/Total days with assessments recorded in the diary for the run-in period) × 28.', 'unitOfMeasure': 'migraine days per month', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The intent-to-treat (ITT) analysis set included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-24', 'size': 2840073, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-24T09:17', 'hasProtocol': True}, {'date': '2024-04-17', 'size': 6052888, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-02T09:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 235}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2020-06-22', 'resultsFirstSubmitDate': '2025-02-24', 'studyFirstSubmitQcDate': '2020-07-02', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-31', 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Monthly Average Number of Migraine Days During 12-Week Period After the First Dose of Study Drug', 'timeFrame': 'Baseline (Day -28 to Day -1), up to Week 12', 'description': 'A migraine day was defined as a day with any of the following: A day (0:00 to 23:59) with at least 2 hours of headache with ≥2 migraine symptom(s) or day (0:00 to 23:59) demonstrating a headache treated with migraine medications (e.g., non-steroidal anti-inflammatory drugs \\[NSAIDs\\], paracetamol etc.), or a headache associated with aura. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in electronic diary (e-diary) for 12-week period) \\* 28. Least square (LS) mean was calculated using analysis of covariance (ANCOVA). The full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug and had at least 10 days of diary entries postbaseline for efficacy assessments on primary endpoint. Efficacy analysis was planned to be collected and evaluated combined for both fremanezumab dose treatment groups.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Baseline up to Month 3', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Number of Participants With Shift From Baseline to Last Assessment in Electrocardiogram (ECG) Findings (Assessed by Investigator)', 'timeFrame': 'Baseline to last assessment (up to Month 3)', 'description': "The number of participants with a shift from Baseline (Normal, Abnormal CS \\[Clinically Significant\\], or Abnormal NCS \\[Not Clinically Significant\\]) in any of the following ECG parameters is reported by treatment group: Heart rate, PR interval, QRS interval, RR interval, QT interval, QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF). Last assessment was defined as the last observed postbaseline interpretation. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section."}, {'measure': 'Number of Participants With Shift From Baseline to Last Assessment in ECG Findings (Assessed by Cardiologist)', 'timeFrame': 'Baseline to last assessment (up to Month 3)', 'description': 'The number of participants with a shift from Baseline (Normal or Abnormal) in any of the following ECG parameters is reported by treatment group: Heart rate, PR interval, QRS interval, RR interval, QT interval, QTcB, and QTcF. Last assessment was defined as the last observed postbaseline interpretation. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Number of Participants With Any One or More Potentially Clinically Significant Vital Signs Abnormalities', 'timeFrame': 'Baseline up to Month 3', 'description': 'Potentially clinically significant abnormal vital signs findings included any one of the following: Pulse rate ≥120 beats per minute (bpm) and increase from baseline of ≥15 bpm, or ≤50 bpm and decrease from baseline of ≥15 bpm; Systolic blood pressure ≤85 millimeters of mercury (mmHg) and decrease from baseline of ≥20 mmHg; Diastolic blood pressure ≥100 mmHg and increase from baseline of ≥15 mmHg; Respiratory rate \\<15 breaths/minute. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Number of Participants With Potentially Clinically Significant Abnormal Laboratory (Serum Chemistry, Hematology, Coagulation, and Urinalysis) Results', 'timeFrame': 'Baseline up to Month 3', 'description': 'Serum chemistry tests with potentially clinically significant abnormal findings included: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) both ≥2\\*upper limit of normal (ULN); and bilirubin ≥34.2 micromole/liter (umol/L). Hematology tests with potentially clinically significant abnormal findings included: hemoglobin ≤100 grams (g)/L, leukocytes ≤3\\*10\\^9 cells/L, neutrophils ≤1\\*10\\^9 cells/L, eosinophils/leukocytes ≥10%, and platelets ≥700\\*10\\^9 cells/L or ≤75\\*10\\^9 cells/L. Coagulation parameter test with potentially clinically significant abnormal findings included: prothrombin international normalized ratio (INR) \\>1.5. Urinalysis laboratory tests with potentially clinically significant abnormal findings included: urine protein ≥2 units (U) increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Number of Participants With Abnormal Physical Examination Findings as Identified by the Investigator', 'timeFrame': 'Baseline up to Month 3', 'description': 'A complete physical examination included the following organ systems: general appearance; head, eyes, ears, nose, and throat (HEENT); chest and lungs; heart; abdomen; musculoskeletal; skin; lymph nodes; and neurological. Only the organ systems with abnormal physical findings in at least one treatment group have been reported. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline and Month 3', 'description': 'C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent.'}, {'measure': 'Mean Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During 12-Week Period After the First Dose of Study Drug', 'timeFrame': 'Baseline (Day -28 to Day -1), up to Week 12', 'description': 'A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the participant reported either of the following: A day with headache pain that lasted ≥2 hours with a peak severity of at least moderate severity or a day where the participant used acute medication (triptans, ergots, NSAIDs or paracetamol) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \\* 28. LS mean was calculated using ANCOVA.'}, {'measure': 'Number of Participants Reaching at Least 50% Reduction in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of Study Drug', 'timeFrame': 'Baseline (Day -28 to Day -1) up to Week 12', 'description': 'A migraine day was defined as a calendar day where the participant reported either of the following: A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache that was accompanied by ≥1 migraine symptom(s) or a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (NSAIDs, paracetamol or triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \\* 28.'}, {'measure': 'Mean Change From Baseline in Monthly Average Number of Days of Use of Any Acute Headache Medications During 12-Week Period After the First Dose of Study Drug', 'timeFrame': 'Baseline (Day -28 to Day -1), up to Week 12', 'description': 'Participants recorded any headache medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken each day in their electronic headache diary device. Acute headache medication included triptans and ergot compounds, NSAIDs or paracetamol. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \\* 28. LS mean was calculated using ANCOVA.'}, {'measure': 'Mean Change From Baseline in Migraine-related Disability Score at Week 12, as Measured by the Pediatric Migraine Disability Assessment (PedMIDAS) Questionnaire', 'timeFrame': 'Baseline, Week 12', 'description': 'The PedMIDAS is a scale developed to assess headache-related disability which can be self-administered by the participant or administered by a caregiver. It has been validated in participants aged 4 to 18 years and includes 3 subscales: the impact of headache on school performance (range of scores 0-92), disability at home (range of scores 0-92), social/sport functioning (range of scores 0-92). The subscales are added to get the total score with a range 0 to 276. The total score was used for grading of disability, with 4 score categories of 0 to 10, 11 to 30, 31 to 50, and 51-276 interpreted as disability grades 1 (little or no disability), 2 (mild disability), 3 (moderate disability), and 4 (severe disability), respectively. Higher total scores indicated severe disability. LS mean was calculated using ANCOVA. The change from baseline score is reported with a range of -276 to 276 with higher scores indicating more severe disability.'}, {'measure': 'Mean Change From Baseline in Quality of Life at Week 12, as Measured by Pediatric Quality of Life Inventory (PedsQL) Questionnaire', 'timeFrame': 'Baseline, Week 12', 'description': 'PedsQL 4.0 is a brief 23-item health-related quality of life (QoL) instrument that evaluates QoL in 4 areas of functioning: physical, emotional, social, and school functioning. For child and adolescent self-report (8 - 18 years) and parent report forms, respondents used a 5-point Likert scale to rate item severity (0=never a problem;1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem). For younger children (5 - 7 years), a simplified 3-point Likert scale, anchored with a happy and a sad face, was used (0=not at all a problem; 2=sometimes a problem; 4=a lot of a problem). PedsQL yields a total QoL score and 2 summary scores: Physical Health Summary Score and Psychosocial Health Summary Score. To obtain scores, items were reverse scored, transformed to a 0 through 100 scale (0=100, 1=75, 2=50, 3=25, 4=0), and averaged; total scores near 0 indicated lower QoL, while scores approaching 100 indicated higher QoL. LS mean was calculated using ANCOVA.'}, {'measure': 'Number of Participants Developing Anti-drug Antibodies (ADAs) Throughout the Study', 'timeFrame': 'Baseline up to Month 3', 'description': 'Number of participants who developed ADAs were reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['episodic migraine'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM).\n\nSecondary objectives are to further demonstrate the efficacy of fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to fremanezumab.\n\nThe total duration of the study is planned to be up to 51 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant has a clinical history of recurrent headache consistent with the diagnosis of migraine for at least 6 months before screening, consistent with ICHD-3 criteria (Headache Classification Committee of the IHS 2013), and a history of ≤=14 headache days per month in each of the 3 months prior to screening (visit 1).\n* The participant or parent/caregiver maintain a prospectively collected headache diary\n* The participant does not have chronic daily headache. For the purposes of this study, chronic daily headache is operationally defined as \\<4 headache-free days during the 28-day baseline period.\n\nNOTE: Additional criteria apply; please contact the investigator for more information.\n\nExclusion Criteria:\n\n* The participant is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) for the treatment of migraine during the 3 months prior to the day of the screening visit.\n* The participant or parent/caregiver maintain a prospectively collected headache diary\n* The participant has used an intervention/device (eg, scheduled nerve block or transcranial magnetic stimulation) for the treatment of migraine or in the head or neck area for any condition during the 2 months prior to the day of the screening visit.\n* The participant has a current history of a clinically significant psychiatric condition, at the discretion of the investigator. Any prior history of a suicide attempt, or a history of suicidal ideation with a specific plan within the past 2 years, must be excluded.\n* The participant has an ongoing infection or a known history of human immunodeficiency virus infection, tuberculosis, Lyme disease, or chronic hepatitis B or C, or a known active infection of coronavirus disease 2019 (COVID-19).\n* The participant has a past or current history of cancer.\n* The participant is pregnant or nursing.\n* The participant has a history of hypersensitivity reactions to injected proteins, including mAbs, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or the participant is concomitantly using lamotrigine.\n* The participant received a live attenuated vaccine (eg, intranasal flu vaccine, and measles, mumps, and rubella vaccine) within the 12-week period prior to screening. Note: If a medical need arises during the study, the participant may receive a live attenuated vaccine.\n* The participant has a current or past medical history of hemiplegic migraine.\n\nNOTE: Additional criteria apply; please contact the investigator for more information.'}, 'identificationModule': {'nctId': 'NCT04458857', 'briefTitle': 'A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age', 'orgStudyIdInfo': {'id': 'TV48125-CNS-30083'}, 'secondaryIdInfos': [{'id': '2019-002055-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fremanezumab Dose A', 'description': 'Participants weighing \\<threshold weight will receive fremanezumab SC at dose A for 3 months.', 'interventionNames': ['Drug: Fremanezumab']}, {'type': 'EXPERIMENTAL', 'label': 'Fremanezumab Dose B', 'description': 'Participants weighing ≥threshold weight will receive fremanezumab SC at dose B for 3 months.', 'interventionNames': ['Drug: Fremanezumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Fremanezumab', 'type': 'DRUG', 'description': 'Dose A or Dose B subcutaneous', 'armGroupLabels': ['Fremanezumab Dose A', 'Fremanezumab Dose B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Teva Investigational Site 14281', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92220', 'city': 'Banning', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 14253', 'geoPoint': {'lat': 33.92557, 'lon': -116.87641}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 14370', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 14322', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 14361', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 14319', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 14368', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14244', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14325', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14250', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14255', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site 14243', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site 14258', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60169', 'city': 'Hoffman Estates', 'state': 'Illinois', 'country': 'United States', 'facility': 'Teva Investigational Site 14263', 'geoPoint': {'lat': 42.04281, 'lon': -88.0798}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Teva Investigational Site 14283', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '67206', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Teva Investigational Site 14245', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Teva Investigational Site 14327', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Teva Investigational Site 14360', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Teva Investigational Site 14365', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '26505', 'city': 'Silver Spring', 'state': 'Maryland', 'country': 'United States', 'facility': 'Teva Investigational Site 14317', 'geoPoint': {'lat': 38.99067, 'lon': -77.02609}}, {'zip': '02451', 'city': 'Waltham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 14246', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Teva Investigational Site 14251', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55402', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Teva Investigational Site 14270', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '39157', 'city': 'Ridgeland', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Teva Investigational Site 14376', 'geoPoint': {'lat': 32.42848, 'lon': -90.13231}}, {'zip': '63044-2513', 'city': 'Bridgeton', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 14256', 'geoPoint': {'lat': 38.767, 'lon': -90.41151}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Teva Investigational Site 14371', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '14226', 'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational Site 14276', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14377', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14248', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 14264', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Teva Investigational Site 14257', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73116', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Teva Investigational Site 14275', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Teva Investigational Site 14363', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '19104-4318', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site 14364', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Teva Investigational Site 14374', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 14252', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 14273', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 14274', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '75235-7701', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 14367', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77087', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 14312', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 14366', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 14241', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Teva Investigational Site 14375', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23510', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Teva Investigational Site 14323', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Teva Investigational Site 14277', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': 'L1Z 0M1', 'city': 'Ajax', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Teva Investigational Site 11180', 'geoPoint': {'lat': 43.85012, 'lon': -79.03288}}, {'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Teva Investigational Site 11182', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K2G 1W2', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Teva Investigational Site 11179', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Teva Investigational Site 11181', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '00380', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Teva Investigational Site 40053', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '70210', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Teva Investigational Site 40049', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '90100', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Teva Investigational Site 40054', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Teva Investigational Site 40052', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '61350', 'city': 'Bad Homburg', 'country': 'Germany', 'facility': 'Teva Investigational Site 32728', 'geoPoint': {'lat': 50.22683, 'lon': 8.61816}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Teva Investigational Site 32729', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Teva Investigational 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'Valladolid', 'country': 'Spain', 'facility': 'Teva Investigational Site 31265', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Teva Medical Expert, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}