Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 5:12 PM
Study NCT ID:
NCT04014634
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2019-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GON-injection for a Sooner and Better Treatment of Cluster Headache
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': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2019-07-08', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Use of attack medication', 'timeFrame': '12 weeks', 'description': 'The total use of attack medication (stratified for oxygen and sumatriptan)'}, {'measure': 'Daily attack severity and duration', 'timeFrame': 'For the total study period and each of the three consecutive 4-week time periods', 'description': 'Mean number, severity (1-10) and duration of attack per day.'}, {'measure': 'Attack-freedom', 'timeFrame': 'days 7, 14 and 28', 'description': 'Percentage of patients that are attack-free at days 7, 14 and 28'}, {'measure': 'Non-cluster headache', 'timeFrame': '12 weeks', 'description': "Occurrence of 'non-cluster' headache (number of days and mean intensity per affected day)"}, {'measure': 'Adverse events', 'timeFrame': '12 weeks', 'description': 'Percentage of subjects with adverse-events (stratified for type of side effect (AE, SAE, SUSAR))'}, {'measure': 'Subjective feeling', 'timeFrame': 'Days 7, 14 and 28', 'description': 'Subjective feeling at days 7, 14 and 28 (visual analogue scale, VAS. Scale from 0 to 10 where 0 is worst imaginable and 10 best imaginable)'}, {'measure': 'Satisfaction score', 'timeFrame': '12 weeks', 'description': 'Satisfaction score (7 point scale, 0 to 6. 0 is completely unsatisfied and 6 completely satisfied)'}, {'measure': 'Recommendation', 'timeFrame': 'Days 7, 14 and 28', 'description': 'Would the patient recommend this treatment to others'}, {'measure': 'Blinding participants', 'timeFrame': 'Days 7, 14 and 28', 'description': 'What treatment does the patient think he/she received (placebo/GON/uncertain)'}, {'measure': 'Blinding investigators', 'timeFrame': 'Days 7, 14 and 28', 'description': 'What treatment do the investigators think the patient has had'}], 'primaryOutcomes': [{'measure': 'Verapamil mean total dose', 'timeFrame': '12 week period', 'description': 'Difference in mean total dose of verapamil used during the study period'}], 'secondaryOutcomes': [{'measure': 'Days to remission', 'timeFrame': '12 weeks', 'description': 'Median number of days to remission (7 consecutive days without attack)'}, {'measure': 'Daily attacks', 'timeFrame': '12 weeks', 'description': 'Mean number of attacks per day during the study period'}, {'measure': 'Peak dose verapamil', 'timeFrame': '12 weeks', 'description': 'Peak dose verapamil'}, {'measure': 'Preamature termination', 'timeFrame': '12 weeks', 'description': 'Premature termination of study due to need for escape medication'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cluster Headache, Episodic', 'Greater Occipital Nerve Injection']}, 'referencesModule': {'references': [{'pmid': '40990636', 'type': 'DERIVED', 'citation': 'Brandt RB, Mulleners WM, Couturier E, Carpay JA, Gerlach OHH, Niesters M, Haan J, van Zwet EW, Ferrari MD, Fronczek R. Greater occipital nerve injection with methylprednisolone as transitional therapy in episodic cluster headache: Results from an RCT. Cephalalgia. 2025 Sep;45(9):3331024251370324. doi: 10.1177/03331024251370324. Epub 2025 Sep 24.'}]}, 'descriptionModule': {'briefSummary': "Cluster headache is a very severe primary headache disorder. In episodic cluster headache, attacks occur in 'bouts' (clusters) lasting weeks to months. Management of cluster headache entails a combination of attack and prophylactic treatment. Current first choice prophylactic treatment (verapamil) has considerable side effects which can be serious and include possibly fatal cardiac arrhythmias; and it can take weeks to titrate to an effective dose. Evidence has emerged that local steroid injection of the greater occipital nerve (GON) may be effective in cluster headache, but this method has not been investigated as a first line prophylactic treatment in a large, well-documented group of episodic cluster headache patients who are still free of prophylactic medication and just entered a new cluster headache episode. As such, GON-injection has not yet found its way into current treatment protocols. The investigators plan to perform this multicentre double-blind randomized controlled trial to investigate whether GON-injection is efficacious as a first-line prophylactic treatment, aiming to remove the need for high doses of daily medication - such as verapamil - with associated side effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients have to be diagnosed with episodic cluster headache according to the international classification of headache disorders - third edition, ICHD-3\n* Patients have to be aged 18-65 years\n* Patients need to be newly diagnosed and treatment naïve, or already diagnosed and currently free from prophylactic treatment\n* Patients need to have a mean of 1 or more attacks per day in the 3 days preceding inclusion.\n* Patients should be in their cluster period for shorter than 4 weeks before inclusion.\n\nExclusion Criteria:\n\n* A contraindication for treatment with steroids or verapamil\n* The use of anticoagulants or known bleeding disorder.\n* Use of any prophylactic medication for cluster headache\n* Patients with a history of other primary headache who are currently using prophylactic medication for this headache\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04014634', 'acronym': 'CHIANTI', 'briefTitle': 'GON-injection for a Sooner and Better Treatment of Cluster Headache', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'GON-injection for a Sooner and Better Treatment of Cluster Headache: a Double-blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NL6719705818'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Injection of NaCl', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Verum', 'interventionNames': ['Drug: Methylprednisolone']}], 'interventions': [{'name': 'Methylprednisolone', 'type': 'DRUG', 'description': 'Single GON injection with methylprednisolone', 'armGroupLabels': ['Verum']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Single GON-injection with NaCl', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Boerhaave Clinics', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Leiden', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'LUMC', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Leiderdorp', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Alrijne Ziekenhuis', 'geoPoint': {'lat': 52.15833, 'lon': 4.52917}}, {'city': 'Blaricum', 'country': 'Netherlands', 'facility': 'Tergooi Ziekenhuis', 'geoPoint': {'lat': 52.2725, 'lon': 5.24167}}, {'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Zuyderland Medisch Centrum', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Canisius-Wilhelmina Hospital', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Rolf Fronczek, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LUMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All Data will be stored using Castor EDC. All hard copies will be stored in the individual centers. If requested, after study completion, data can be shared with de PIs in participating centers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Netherlands Brain Foundation', 'class': 'OTHER'}, {'name': 'Innovatiefonds Zorgverzekeraars', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'RolfFronczek', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}