Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-02-25 @ 6:56 PM
Study NCT ID:
NCT04406259
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2020-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrioventricular Block and Cluster Headache (SEVA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003027', 'term': 'Cluster Headache'}], 'ancestors': [{'id': 'D051303', 'term': 'Trigeminal Autonomic Cephalalgias'}, {'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': 'D014700', 'term': 'Verapamil'}], 'ancestors': [{'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'prospective cohort, interventional , multicentric study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-09-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2020-05-14', 'studyFirstSubmitQcDate': '2020-05-22', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the atrioventricular block when verapamil is used in prevention of Cluster Headache.', 'timeFrame': '27 months', 'description': 'Occurrence of the ratio of patients presenting a first degree atrioventricular block'}], 'secondaryOutcomes': [{'measure': 'Description of the different atrioventricular conduction abnormities and their incidence', 'timeFrame': '27 months', 'description': 'Study of ECG results'}, {'measure': 'Evaluation of the plasmatic concentration of verapamil and its metabolite (nor verapamil) in parallel with the occurrence of conduction abnormalities detected by electrocardiogram', 'timeFrame': '27 months', 'description': 'Plasmatic concentration of verapamil and its metabolite (nor verapamil) dosed at each visit'}, {'measure': 'Relation between pharmacokinetic/ pharmacodynamics of verapamil and the appearance of conduction abnormalities to determinate the maximal tolerated dose of verapamil.', 'timeFrame': '27 months', 'description': 'The maximal tolerated dose of verapamil will be determined thanks to correlation between ECG results and Pharmacocinetics and pharmacodynamics'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cluster Headache']}, 'descriptionModule': {'briefSummary': 'Verapamil is a calcium channel blocker widely used to treat cardiovascular diseases however it is also the first line treatment in the prevention of cluster headaches. In France, its prescription in that indication is based on compliance with the Temporary Recommendation for Use (RTU) that insists on the possible the cardiac side effects that can occur as the doses required for cluster headache are significantly higher than the doses used in cardiology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patient 18 years old, and older\n* patient suffering from Cluster Headache (according to the l'ICHD-3 diagnostic criterias)\n* patients affiliated to the social security\n* patient that has given his full written consent to participate in the study\n* female patients participating in the study must be using an efficient contraception for more than 1 month prior to the beginning of the study\n\nExclusion Criteria:\n\n* patient presenting contraindications to the use of verapamil\n* patient observing a treatment with ivabradine (Procoralan®), bétablockers, colchicine, l'esmolol, triazolam, quinidine.\n* patient under justicial protection\n* patient breastfeeding, or pregnant\n* patient suffering from a neuromuscular transmisson disease\n* patient with a pacemaker"}, 'identificationModule': {'nctId': 'NCT04406259', 'acronym': 'SEVA', 'briefTitle': 'Atrioventricular Block and Cluster Headache (SEVA)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Atrioventricular Block and Cluster Headache', 'orgStudyIdInfo': {'id': '18-API-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Verapamil', 'description': 'administration of verapamil to treat cluster headache', 'interventionNames': ['Drug: Verapamil']}], 'interventions': [{'name': 'Verapamil', 'type': 'DRUG', 'description': 'Patients in groupe A require verapamil initiation as a preventive treatment and patients in group B are patients already undergoing a verapamil treatment for their Cluster Headache.\n\nThe doses of verapamil are increased for the patients in group A, after a clinical examination an electrocardiogram, and a blood test.', 'armGroupLabels': ['Verapamil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06003', 'city': 'Nice', 'state': 'CHUN', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'AP-HP Hôpital la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data sharing plan ahs been established'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}