Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-30 @ 6:07 PM
Study NCT ID:
NCT00804895
Status:
COMPLETED
Last Update Posted:
2012-11-27
First Post:
2008-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cluster Headache Cortivazol Injection (CHCI)
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-23', 'studyFirstSubmitDate': '2008-12-08', 'studyFirstSubmitQcDate': '2008-12-08', 'lastUpdatePostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with a daily attack frequency equal or inferior to two for the period going from two days after third injection to four days after the third injection', 'timeFrame': '2009'}], 'secondaryOutcomes': [{'measure': 'total number of attacks on the J1-J15 period', 'timeFrame': '2009'}, {'measure': 'percentage of patients with a 50% or more decrease in attacks frequency at J15', 'timeFrame': '2009'}, {'measure': 'percentage of patients reaching a remission at J30 defined as an absence of attacks for seven days or more', 'timeFrame': '2009'}, {'measure': 'interval between the first injection and appearance of a remission', 'timeFrame': '2009'}, {'measure': 'percentage of patients suffering from chronic CH, having reached a daily attack frequency equal or inferior to two, presenting a recurrence of attacks after J15, defined as more than two attacks per day', 'timeFrame': '2009'}, {'measure': 'number of patients (episodic or chronic) presenting a daily attack frequency equal or inferior to two at J30', 'timeFrame': '2009'}, {'measure': 'number of chronic patients presenting a daily attack frequency equal or inferior to two at J90', 'timeFrame': '2009'}, {'measure': 'HIT-6 scores, comparison between groups at J0 and J30', 'timeFrame': '2009'}, {'measure': 'tolerance of treatment : percentage of patients showing side effects', 'timeFrame': '2009'}, {'measure': 'safety of treatment: percentage of patients with serious adverse events', 'timeFrame': '2009'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cluster headache', 'greater occipital nerve block', 'cortivazol'], 'conditions': ['Cluster Headache']}, 'referencesModule': {'references': [{'pmid': '21903477', 'type': 'RESULT', 'citation': 'Leroux E, Valade D, Taifas I, Vicaut E, Chagnon M, Roos C, Ducros A. Suboccipital steroid injections for transitional treatment of patients with more than two cluster headache attacks per day: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2011 Oct;10(10):891-7. doi: 10.1016/S1474-4422(11)70186-7. Epub 2011 Sep 6.'}]}, 'descriptionModule': {'briefSummary': 'the aim of tis study is to demonstrate the efficacy of cortivazol injections at the level of the greater occipital nerve to diminish the frequency of cluster headache (episodic or chronic) attacks during an active period. Injections will be used in adjunct with oral verapamil.', 'detailedDescription': 'Cluster headache is characterized by unilateral attacks of severe periorbital pain accompanied by autonomic symptoms and restlessness. Though patients may respond to the standard prophylactic treatment of verapamil, some are refractory and continue to suffer from numerous attacks, with a limit of two doses of subcutaneous sumatriptan per day. Some patients also have contra-indications to standard prophylactic or acute treatments. Other preventive treatments like systemic steroids, lithium and methysergide may cause significant side effects. We intend to show the efficacy of occipital nerve injections with cortivazol, in adjunct to verapamil, in cluster headache patients. We expect a diminution of attack frequency over two weeks, with a protocol of three injections separated by two or three days each. Tolerance and safety will be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient age, man or woman whose age is between 18 and 65 included\n* patient who signed a free express and informed consent\n* patient with cluster headache, episodic or chronic according to the criteria of International Headache Society (ICHD-II)\n* patient with more than two episodes of CH per day\n* patient with a normal medical examination\n\nExclusion Criteria:\n\n* patient not affiliated with a social security scheme (or beneficiary entitled)\n* patient with another diagnosis ICHD-II,and being unable to differentiate CH attacks from its other cranial pain\n* patient of CH having started his episodic active period more than 30 days ago\n* patient with a contra-indication to verapamil\n* patient with a known allergy to cortivazol\n* patient with anticoagulant therapy or having a bleeding disorder\n* patient unable to complete the schedule crisis\n* patient non-compliant or unable to follow the research protocol\n* women without contraception, pregnant, or nursing'}, 'identificationModule': {'nctId': 'NCT00804895', 'acronym': 'CHCI', 'briefTitle': 'Cluster Headache Cortivazol Injection (CHCI)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache', 'orgStudyIdInfo': {'id': 'P080602'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'subcutaneous injection of Cortivazol ALTIM, 3,375mg', 'interventionNames': ['Drug: ALTIM, cortivazol injections', 'Drug: Verapamil']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'PROAMP, subcutaneous serum physiological saline', 'interventionNames': ['Drug: PROAMP, subcutaneous serum physiological saline', 'Drug: Verapamil']}], 'interventions': [{'name': 'ALTIM, cortivazol injections', 'type': 'DRUG', 'otherNames': ['ALTIM, cortivazol injections greater occipital'], 'description': 'ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each.', 'armGroupLabels': ['1']}, {'name': 'PROAMP, subcutaneous serum physiological saline', 'type': 'DRUG', 'description': 'Three injections will be performed at the level of the greater occipital nerve with a suboccipital approach. Injection will be separated by two or three days each.', 'armGroupLabels': ['2']}, {'name': 'Verapamil', 'type': 'DRUG', 'description': 'standard prophylactic treatment', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Dominique VALADE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Lariboisière, AP-HP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}