Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-01-08 @ 3:40 PM
Study NCT ID:
NCT00291395
Status:
TERMINATED
Last Update Posted:
2006-10-26
First Post:
2006-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}, {'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 12}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'lastUpdateSubmitDate': '2006-10-25', 'studyFirstSubmitDate': '2006-02-13', 'studyFirstSubmitQcDate': '2006-02-13', 'lastUpdatePostDateStruct': {'date': '2006-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache'}], 'secondaryOutcomes': [{'measure': 'rCBF, blood flow, diameter of STA/RA, HR, BP'}]}, 'conditionsModule': {'conditions': ['Headache', 'Migraine']}, 'descriptionModule': {'briefSummary': 'Before , during and after intravenous administration of PGI2 we score/measure headache, rCBF, blood flow in middle cerebral artery and diameter of superficial temporal artery/radial artery and correlate that to known patophysiology of headache to see if PGI2 is involved in headache pathophysiology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers,\n\nExclusion Criteria:\n\n* Primary headache,\n* headache on the day of investigation,\n* Hypertension,\n* hypotension,\n* pregnant/nursing\n* Daily intake of medication (except oral contraceptives)\n* Cardiovascular or CNS disease\n* Drug/Alcohol abuse\n* Psychiatric disease'}, 'identificationModule': {'nctId': 'NCT00291395', 'briefTitle': 'PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'orgStudyIdInfo': {'id': 'KA05055'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PGI2', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2600', 'city': 'Glostrup Municipality', 'state': 'Glostrup', 'country': 'Denmark', 'facility': 'Danish Headache Center', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Troels Wienecke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Headache Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}}}}