Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-30 @ 2:18 AM
Study NCT ID:
NCT06446804
Status:
COMPLETED
Last Update Posted:
2024-11-01
First Post:
2024-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up of Migraine Patients on Eptinezumab
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-06-05', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headaches and migraines per month', 'timeFrame': '6 months', 'description': 'Number of headache and migraine days per month.'}, {'measure': 'Responders', 'timeFrame': '6 months', 'description': 'Rate of responders (30%, 50% and super responders \\> 75%)'}, {'measure': 'Duration', 'timeFrame': '6 months', 'description': 'Duration of effect of eptinezumab infusion (Numbers of weeks)'}, {'measure': 'HIT6 scores (disability score)', 'timeFrame': '6 months', 'description': 'Evaluation of HIT6 scores (disability score),\n\n≤ 49 headaches have little impact on daily life; between 50 and 55: headaches have some impact on daily life; 56 to 59: headaches have a significant impact on daily life; ≥ 60'}, {'measure': 'HAD (anxiety/depression score)', 'timeFrame': '6 months', 'description': 'Evaluation of HAD score. From 0 to 7: absence of anxiety and/or depressive disorders, from 8 to 10: doubtful symptomatology, 11 to 21: proven anxiety and/or depression disorders of varying severity.'}, {'measure': 'Concomitant treatments', 'timeFrame': '6 months', 'description': 'Use of concomitant crisis and background treatments (description)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'The October 2022 Transparency Commission considers that VYEPTI (eptinezumab) is a treatment option for patients suffering from severe migraine with at least 8 migraine days per month, who have failed at least two prophylactic treatments and have no cardiovascular impairment.\n\nSince the beginning of 2023, eptinezumab has been available in France as an inpatient treatment prescribed by a migraine neurologist in a growing number of centres. The Saint-Denis Hospital and the Nîmes University Hospital are among the first centres to have started. The investigators from these 2 centres have therefore decided to pool their data to provide the first French feedback on its effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with severe migraine with at least 8 migraine days per month and failure of at least 2 disease-modifying therapies, treated with quarterly infusions of eptinezumab since March 2023 in a day hospital at the Saint-Denis hospital and the Nîmes university hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients suffering from severe migraine with at least 8 migraine days per month\n\n * Patients who have failed at least 2 disease-modifying treatments,\n * Patients treated with quarterly infusions of eptinezumab since March 2023 in a day hospital at Saint-Denis Hospital and Nîmes University Hospital.\n\nExclusion Criteria:\n\n* Patient refusing to participate'}, 'identificationModule': {'nctId': 'NCT06446804', 'acronym': 'EPTI-CO', 'briefTitle': 'Follow-up of Migraine Patients on Eptinezumab', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Feedback on the Use of Eptinezumab: Efficacy at 6 Months in Severe Migraine', 'orgStudyIdInfo': {'id': 'LOCAL/2024/AL-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Migraine patients', 'description': 'Patients with severe migraine, with at least 8 migraine days per month and at least 2 failed background treatments.', 'interventionNames': ['Other: None, pure observationnal study']}], 'interventions': [{'name': 'None, pure observationnal study', 'type': 'OTHER', 'description': 'Pure observatonnal study', 'armGroupLabels': ['Migraine patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30900', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '93200', 'city': 'Saint-Denis', 'country': 'France', 'facility': 'CH de Saint Denis', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}], 'overallOfficials': [{'name': 'Anissa MEGZARI', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire de Nīmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}