Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:39 PM
Study NCT ID:
NCT03585894
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2018-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Inflammation and Vasodilatation in PACAP38-induced Headache Using MRI on Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018170', 'term': 'Sumatriptan'}, {'id': 'D020910', 'term': 'Ketorolac'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007213', 'term': 'Indomethacin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each participant will receive PACAP28 intravenous infusion over 20 min in both experiment days but treated in randomized order with sumatriptan or ketorolac.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-29', 'studyFirstSubmitDate': '2018-06-28', 'studyFirstSubmitQcDate': '2018-07-12', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra-extra cerebral arteries vasodilatation', 'timeFrame': '120 minutes', 'description': 'PACAP38 vasodilatation reverse by sumatriptan but not ketorolac. A single-slab 3D time-of-flight (3D TOF) MRA of extra- and intracranial arteries will be acquired as described in previous studies (Amin et al., 2013, 2014). MRA data will be analyzed by LKEB-MRA vessel wall analysis software program. We will measure the circumference of vessels in millimeter in 4 predefined time points (0, 20, 60 and 110 min)'}, {'measure': 'Headache score', 'timeFrame': '6 hours', 'description': 'Visual analog Scale'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '2 hours', 'description': 'vital parameters recorded at hospital phase'}, {'measure': 'Headache characteristics', 'timeFrame': '24 hours', 'description': 'Standard headache questionnaire will be used to record headache localization, nausea, photo and phonophobia.'}, {'measure': 'Heart rate', 'timeFrame': '2 hours', 'description': 'vital parameters recorded at hospital phase'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Headache']}, 'referencesModule': {'references': [{'pmid': '32093617', 'type': 'DERIVED', 'citation': 'Ghanizada H, Al-Karagholi MA, Arngrim N, Morch-Rasmussen M, Metcalf-Clausen M, Larsson HBW, Amin FM, Ashina M. Investigation of sumatriptan and ketorolac trometamol in the human experimental model of headache. J Headache Pain. 2020 Feb 24;21(1):19. doi: 10.1186/s10194-020-01089-3.'}]}, 'descriptionModule': {'briefSummary': 'Studying Pituitary adenylate cyclase-activating peptide 38 (PACAP38) induced headache effects on extra- and intracerebral arteries and pre-posttreated by sumatriptan and ketorolac assessed by magnetic resonance imaging (MRI) on healthy volunteers.', 'detailedDescription': "The purpose of this research project is to investigate the importance of blood vessel (vasodilatation), vessel wall inflammation and blood flow in arteries of headaches triggered by PACAP38 and for headache treated with sumatriptan (migraine medicine) and ketorolac (NSAID). In addition, we will investigate headache-related changes in the brain's network connectivity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* Aged 18-50\n* 50-100 kg\n\nExclusion Criteria:\n\n* Tension type headache more than 5 dag /month\n* Other primary headaches\n* Daily medication except contraceptives\n* Drug taken within 4 times the half-life for the specific drug except contraceptives\n* Pregnant or lactating women\n* Exposure to radiation within the last year\n* Headache within the last 24 hours before start of trial\n* Hypertension\n* Hypotension\n* Respiratory or cardiac disease\n* Primary relatives with current or previous migraine'}, 'identificationModule': {'nctId': 'NCT03585894', 'briefTitle': 'The Role of Inflammation and Vasodilatation in PACAP38-induced Headache Using MRI on Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'The Role of Inflammation and Vasodilatation in PACAP38-induced Headache Using MRI on Healthy Subjects', 'orgStudyIdInfo': {'id': 'H-18008313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sumatriptan', 'description': 'Sumatriptan 4 mg/mL I.V will be administrated over 10 min', 'interventionNames': ['Other: Sumatriptan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketorolac', 'description': 'Ketorolac 30 mg/mL I.V will be administrated over 10 min', 'interventionNames': ['Other: Ketorolac']}], 'interventions': [{'name': 'Sumatriptan', 'type': 'OTHER', 'description': 'Receive intravenous infusion of sumatriptan', 'armGroupLabels': ['Sumatriptan']}, {'name': 'Ketorolac', 'type': 'OTHER', 'description': 'Receive intravenous infusion of ketorolac', 'armGroupLabels': ['Ketorolac']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Danish Headache Center', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Hashmat Ghanizada', 'investigatorAffiliation': 'Danish Headache Center'}}}}