Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT05342493
Status:
RECRUITING
Last Update Posted:
2025-03-21
First Post:
2022-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-06-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2022-04-17', 'studyFirstSubmitQcDate': '2022-04-17', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety information (Adverse Event)', 'timeFrame': '2 years from the start date of treatment', 'description': 'Any untoward medicinal occurrence in a patient or clinical study subject administered a Medicinal Product and which does not necessarily have a causal relationship with this treatment (see Annex Ⅳ, ICH-E2A Guideline).\n\nAn Adverse Event can therefore be any unfavorable and unintended sign (e.g. abnormal laboratory finding), symptom, or disease temporally associated with the use of a Medicinal Product, whether or not it is considered causally related to the Medicinal Product.'}, {'measure': 'Number of Special Situations', 'timeFrame': '2 years from the start date of treatment', 'description': "Collecting any Situations related to the use of an Otsuka product which may or may not be associated with an adverse event:\n\n* Maternal (pregnancy and breastfeeding) or paternal (via semen) exposure;\n* Exposure during breastfeeding;\n* Overdose/Incorrect dosage, misuse, abuse (e.g. patient sharing products);\n* Medication errors (e.g. patient took wrong dose);\n* Lack of therapeutic efficacy (e.g. the product doesn't work);\n* Occupational exposure (e.g.: nurse administering the product is exposed);\n* Cases of suspected transmission of infectious agents;\n* Use of suspected or confirmed falsified product(s) or quality defect of the product(s);\n* Withdrawal reactions;\n* Accidental exposure (e.g.: child takes parent's product);\n* Drug-drug/drug-food interactions;\n* Unintentional use of product in a non-approved population (e.g.: pediatric or geriatric population);\n* Disease progression/exacerbation of existing disease"}, {'measure': 'Number of off-Label Use', 'timeFrame': '2 years from the start date of treatment', 'description': 'Collecting any type of off-Label Use that refers to situations where a product is intentionally used for a medical purpose not in accordance with the authorized product information. Off-label use also includes the intentional use in non-authorized population categories not indicated in the label.'}, {'measure': 'Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening)', 'timeFrame': '2 years from the start date of treatment', 'description': 'Collecting the number of any adverse drug experience/event occurring at any dose which\n\n* results in death\n* is life-threatening\n* requires inpatient hospitalization or prolonged of existing hospitalization\n* results in persistent or significant disability or incapacity\n* is a congenital anomaly/birth defect\n* is medically significant.'}, {'measure': 'Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event)', 'timeFrame': '2 years from the start date of treatment', 'description': 'Collecting the number of non-serious Adverse Events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine Disorders']}, 'descriptionModule': {'briefSummary': 'To evaluate the long-term safety of AJOVY in patients under actual use conditions and to specifically evaluate cardiovascular events. In addition, information on efficacy will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in Japan who are planned to be newly started on Ajovy syringe for SC injection 225 mg therapy for the suppression of migraine attacks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* patients with a known hypersensitivity to components of AJOVY'}, 'identificationModule': {'nctId': 'NCT05342493', 'briefTitle': 'Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': 'AJOVY Subcutaneous Injection Long-term Specified Use-results Survey', 'orgStudyIdInfo': {'id': '406-101-00013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Drug', 'description': 'Ajovy syringe for SC injection 225 mg.', 'interventionNames': ['Drug: Fremanezumab 225 Mg/1.5 mL Subcutaneous Solution']}], 'interventions': [{'name': 'Fremanezumab 225 Mg/1.5 mL Subcutaneous Solution', 'type': 'DRUG', 'description': 'The usual adult dose is 225 mg of fremanezumab (genetical recombination) administered subcutaneously as a single dose once every 4 weeks or 675 mg administered subcutaneously as a single dose once every 12 weeks.', 'armGroupLabels': ['Drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '540-0021', 'city': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Satoshi Komaniwa, PhD', 'role': 'CONTACT'}], 'facility': 'Pharmacovigilance Department', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'centralContacts': [{'name': 'Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd', 'role': 'CONTACT', 'email': 'komaniwa.satoshi@otsuka.jp', 'phone': '+81-6-6943-7722'}], 'overallOfficials': [{'name': 'Yasuhiko Fukuta, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Otsuka Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}