Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-18 @ 1:34 AM
Study NCT ID:
NCT06603558
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2024-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Marketing Study to Assess the Safety and Effectiveness of Oral Atogepant in Korean Adult Participants for the Prevention of Chronic or Episodic Migraine
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': 'C000718987', 'term': 'atogepant'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2024-09-17', 'studyFirstSubmitQcDate': '2024-09-17', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage (%) of participants who reported serious adverse event (SAE)/drug reaction (SADR)', 'timeFrame': 'Up to approximately 16 Weeks', 'description': 'Percentage (%) of participants who reported serious adverse event (SAE)/drug reaction (SADR)'}, {'measure': 'Percentage (%) of participants who reported unexpected (not reflected in the latest approved label) adverse event (AE)/drug reaction (ADR)', 'timeFrame': 'Up to approximately 16 Weeks', 'description': 'Percentage (%) of participants who reported unexpected (not reflected in the latest approved label) adverse event (AE)/drug reaction (ADR)'}, {'measure': 'Percentage (%) of participants who reported known (labeled) ADR', 'timeFrame': 'Up to approximately 16 Weeks', 'description': 'Percentage (%) of participants who reported known (labeled) ADR'}, {'measure': 'Percentage (%) of participants who reported non-serious AE/ADR', 'timeFrame': 'Up to approximately 16 Weeks', 'description': 'Percentage (%) of participants who reported non-serious AE/ADR'}, {'measure': 'Percentage (%) of participants who reported the events related to important potential risks and missing information defined in the Risk Management Plan (RMP)', 'timeFrame': 'Up to approximately 16 Weeks', 'description': 'Percentage (%) of participants who reported the events related to important potential risks and missing information defined in the RMP'}, {'measure': 'Percentage (%) of participants with AE: overall summary', 'timeFrame': 'Up to approximately 16 Weeks', 'description': 'Percentage (%) of participants with AE: overall summary'}, {'measure': 'Percentage (%) of participants with common (>=5%) AE', 'timeFrame': 'Up to approximately 16 Weeks', 'description': 'Percentage (%) of participants with common (\\>=5%) AE'}, {'measure': 'Percentage (%) of participants with AE leading to treatment discontinuation', 'timeFrame': 'Up to approximately 16 Weeks', 'description': 'Percentage (%) of participants with AE leading to treatment discontinuation'}, {'measure': 'Percentage (%) of participants who reported treatment-related AE per the investigator causality assessment', 'timeFrame': 'Up to approximately 16 Weeks', 'description': 'Percentage (%) of participants who reported treatment-related AE per the investigator causality assessment'}, {'measure': 'Percentage (%) of participants who reported treatment-related serious AE per the investigator causality assessment', 'timeFrame': 'Up to approximately 16 Weeks', 'description': 'Percentage (%) of participants who reported treatment-related serious AE per the investigator causality assessment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Migraine', 'Episodic Migraine', 'Migraine', 'Atogepant', 'Qulipta', 'Aquipta'], 'conditions': ['Chronic Migraine', 'Episodic Migraine', 'Migraine']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=P24-480', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The study will assess the safety and effectiveness of atogepant for the preventive treatment of migraine in Korean adult patients with chronic migraine or episodic migraine under routine clinical practice.\n\nAtogepant is an approved drug for preventive treatment of migraine in adults. Approximately 3000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study in Korea.\n\nParticipants will receive atogepant oral tablets as prescribed by their physician. Participants will be followed for up to week 12.\n\nThere is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants who have been prescribed atogepant for preventive treatment migraine according to the latest approved local label in routine clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with migraine suitable for the treatment with atogepant according to the latest approved local label.\n* Participants prescribed atogepant in accordance with the approved local label.\n\nExclusion Criteria:\n\n* Participants with any contraindication to atogepant as listed on the latest approved local label.\n* Participants currently participating in another clinical research except observational study.'}, 'identificationModule': {'nctId': 'NCT06603558', 'acronym': 'Atogepant PMSS', 'briefTitle': 'Post-Marketing Study to Assess the Safety and Effectiveness of Oral Atogepant in Korean Adult Participants for the Prevention of Chronic or Episodic Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Post-marketing Surveillance Study to Evaluate the Safety and Effectiveness of Atogepant for the Prevention of Migraine in Korean Adult Patients', 'orgStudyIdInfo': {'id': 'P24-480'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atogepant', 'description': 'Participants will receive atogepant as prescribed by their physician according to the local label.', 'interventionNames': ['Drug: Atogepant']}], 'interventions': [{'name': 'Atogepant', 'type': 'DRUG', 'otherNames': ['Qulipta', 'Aquipta'], 'description': 'Oral Tablet', 'armGroupLabels': ['Atogepant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18450', 'city': 'Hwaseong', 'state': 'Gyeonggido', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Hallym University Dongtan Sacred Heart Hospital /ID# 273581', 'geoPoint': {'lat': 35.24246, 'lon': 126.59882}}, {'zip': '03080', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Hospital /ID# 271892', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03181', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital /ID# 271893', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Yonsei University Health System Severance Hospital /ID# 272639', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Celine Im', 'role': 'CONTACT', 'email': 'celine.im@abbvie.com', 'phone': '+82-10-2230-3629'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}