Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-03-09 @ 9:19 AM
Study NCT ID:
NCT03303105
Status:
COMPLETED
Last Update Posted:
2023-02-17
First Post:
2017-10-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000604315', 'term': 'fremanezumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CL_OPCJ_RDA_Team@otsuka.jp', 'phone': '+81-3-6361-7366', 'title': 'Director of Clinical Trials', 'organization': 'Otsuka Pharmaceutical Co., LTD.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline (Day 0) up to follow-up visit (Day 562)', 'description': 'Safety Set (SS): Newly enrolled subjects who received the IMP at least once', 'eventGroups': [{'id': 'EG000', 'title': 'TEV-48125 (225 mg/1 Month) Group', 'description': 'TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly \\[except for a loading dose of 675 mg in subjects with chronic migraine).', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 20, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TEV-48125 (675 mg/3 Month) Group', 'description': 'TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 16, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}], 'seriousEvents': [{'term': 'Rhegmatogenous retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With at Least One Treatment-Emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 (225 mg/1 Month) Group', 'description': 'TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly \\[except for a loading dose of 675 mg in subjects with chronic migraine).'}, {'id': 'OG001', 'title': 'TEV-48125 (675 mg/3 Month) Group', 'description': 'TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '92.0', 'groupId': 'OG000'}, {'value': '88.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 0) up to follow-up visit (Day 562)', 'description': '* TEAEs are defined as the AEs that started after trial investigational medicinal product (IMP) treatment. Multiple occurrences of TEAEs are counted once per MedDRA preferred term.\n* Specific AE terms are provided in the Adverse Event section.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set (SS): Newly enrolled subjects who received the IMP at least once'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Monthly (28 Day) Average Number of Migraine Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 (225 mg/1 Month) Group', 'description': 'TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly \\[except for a loading dose of 675 mg in subjects with chronic migraine).'}, {'id': 'OG001', 'title': 'TEV-48125 (675 mg/3 Month) Group', 'description': 'TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.9', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe.\n\nSubjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.', 'unitOfMeasure': 'days/month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis set (FAS): Newly enrolled subjects for whom electronic headache diary efficacy assessment data at baseline and after the first dose of IMP were available'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Least Moderate Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 (225 mg/1 Month) Group', 'description': 'TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly \\[except for a loading dose of 675 mg in subjects with chronic migraine).'}, {'id': 'OG001', 'title': 'TEV-48125 (675 mg/3 Month) Group', 'description': 'TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.3', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe.\n\nSubjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.', 'unitOfMeasure': 'days/month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis set (FAS): Newly enrolled subjects for whom electronic headache diary efficacy assessment data at baseline and after the first dose of IMP were available'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TEV-48125 (225 mg/1 Month) Group', 'description': 'TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly \\[except for a loading dose of 675 mg in subjects with chronic migraine).'}, {'id': 'FG001', 'title': 'TEV-48125 (675 mg/3 Month) Group', 'description': 'TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TEV-48125 (225 mg/1 Month) Group', 'description': 'TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly \\[except for a loading dose of 675 mg in subjects with chronic migraine).'}, {'id': 'BG001', 'title': 'TEV-48125 (675 mg/3 Month) Group', 'description': 'TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.8', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '45.8', 'spread': '7.0', 'groupId': 'BG001'}, {'value': '46.3', 'spread': '7.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-08', 'size': 901341, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-27T20:51', 'hasProtocol': True}, {'date': '2019-12-11', 'size': 395196, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-27T20:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2017-10-02', 'resultsFirstSubmitDate': '2021-06-27', 'studyFirstSubmitQcDate': '2017-10-02', 'lastUpdatePostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-27', 'studyFirstPostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With at Least One Treatment-Emergent Adverse Event (TEAE)', 'timeFrame': 'Baseline (Day 0) up to follow-up visit (Day 562)', 'description': '* TEAEs are defined as the AEs that started after trial investigational medicinal product (IMP) treatment. Multiple occurrences of TEAEs are counted once per MedDRA preferred term.\n* Specific AE terms are provided in the Adverse Event section.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in the Monthly (28 Day) Average Number of Migraine Days', 'timeFrame': 'Baseline, Month 12', 'description': 'Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe.\n\nSubjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.'}, {'measure': 'Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Least Moderate Severity', 'timeFrame': 'Baseline, Month 12', 'description': 'Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe.\n\nSubjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '34687446', 'type': 'DERIVED', 'citation': 'Sakai F, Suzuki N, Ning X, Ishida M, Usuki C, Iba K, Isogai Y, Koga N. Long-Term Safety and Tolerability of Fremanezumab for Migraine Preventive Treatment in Japanese Outpatients: A Multicenter, Randomized, Open-Label Study. Drug Saf. 2021 Dec;44(12):1355-1364. doi: 10.1007/s40264-021-01119-2. Epub 2021 Oct 23.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the long-term safety and tolerability of subcutaneous (SC) administration of TEV-48125 (at 225 mg once monthly \\[except for a loading dose of 675 mg for CM patients\\] or at 675 mg every 3 months) for the preventive treatment of Chronic Migraine and Episodic Migraine patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has a history of migraine (according to The International Classification of Headache Disorders, third edition \\[beta version\\] criteria) or clinical judgment suggests a migraine diagnosis\n* Patient fulfills the criteria for Chronic migraine or Episodic migraine in baseline information collected during the 28 day screening period\n* Not using preventive migraine medications for migraine or other medical conditions or using no more than 2 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent.\n* Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator.\n\nExclusion Criteria:\n\n\\- Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator'}, 'identificationModule': {'nctId': 'NCT03303105', 'briefTitle': 'Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Open-label Trial Evaluating the Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine', 'orgStudyIdInfo': {'id': '406-102-00003'}, 'secondaryIdInfos': [{'id': 'JapicCTI-173726', 'type': 'OTHER', 'domain': 'Japic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TEV-48125 (225 mg/1 month) group', 'description': 'TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly \\[except for a loading dose of 675 mg in subjects with CM\\]).', 'interventionNames': ['Drug: TEV-48125']}, {'type': 'EXPERIMENTAL', 'label': 'TEV-48125 (675 mg/3 month) group', 'description': 'TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).', 'interventionNames': ['Drug: TEV-48125']}], 'interventions': [{'name': 'TEV-48125', 'type': 'DRUG', 'description': 'TEV-48125 will be administered subcutaneously once every 4 weeks.', 'armGroupLabels': ['TEV-48125 (225 mg/1 month) group']}, {'name': 'TEV-48125', 'type': 'DRUG', 'description': 'TEV-48125 will be administered subcutaneously once every 12 weeks.', 'armGroupLabels': ['TEV-48125 (675 mg/3 month) group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Iruma', 'country': 'Japan', 'facility': 'Saitama Medical University Hospital', 'geoPoint': {'lat': 35.818, 'lon': 139.368}}], 'overallOfficials': [{'name': 'Takehisa Matsumaru', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Otsuka Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}