Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT00255320
Status:
COMPLETED
Last Update Posted:
2005-12-09
First Post:
2005-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Experimental Headache Induced by Vasoactive Intestinal Polypeptide
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-12', 'completionDateStruct': {'date': '2004-06'}, 'lastUpdateSubmitDate': '2005-12-07', 'studyFirstSubmitDate': '2005-11-16', 'studyFirstSubmitQcDate': '2005-11-16', 'lastUpdatePostDateStruct': {'date': '2005-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache intensity, Mean velocity of blood flow in the middle cerebral artery (VmeanMCA), superfical temporal artery diameter, PetCO2, adverse events and vital signs were recorded at T-10, T0 and then every 10 min until 120 min after start of infusion.'}], 'secondaryOutcomes': [{'measure': 'All subjects were asked to complete a headache diary every hour until 10 h after the discharge. The diary included headache characteristics and accompanying symptoms according to the International Headache Society (IHS 2004)'}]}, 'conditionsModule': {'keywords': ['healthy volunteers, headache, migraine, hemodynamics, VIP, SPECT, ultrasound'], 'conditions': ['Healthy Volunteers, Headache, Migraine, Hemodynamics, VIP, SPECT, Ultrasound']}, 'descriptionModule': {'briefSummary': 'We hypothesized that infusion of VIP may induce headache in healthy subjects and that VIP induced headache may be associated with dilatation of intra- and extracerebral blood vessels. To test this hypothesis, we performed a double blind placebo controlled crossover study in normal human volunteers and studied the effect on headache and cerebral as well as hemodynamic parameters.', 'detailedDescription': 'We hypothesized that infusion of VIP may induce headache in healthy subjects and that VIP induced headache may be associated with dilatation of intra- and extracerebral blood vessels. To test this hypothesis, we performed a double blind placebo controlled crossover study in normal human volunteers and studied the effect on headache and cerebral as well as hemodynamic parameters. In a double-blind, placebo-controlled, crossover design, the subjects were randomly allocated to receive 8 pmol/kg/min VIP or placebo (isotonic saline) over 25 min. Headache intensity, Mean velocity of blood flow in the middle cerebral artery (VmeanMCA), superfical temporal artery diameter, PetCO2, adverse events and vital signs were recorded at T-10, T0 and then every 10 min until 120 min after start of infusion. Single photon emission computerized tomography (SPECT) was performed at T-0, T20 and T60.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- healthy volunteers\n\nExclusion Criteria:\n\n\\- migraine cerebrovascular disorders pregnancy'}, 'identificationModule': {'nctId': 'NCT00255320', 'briefTitle': 'Experimental Headache Induced by Vasoactive Intestinal Polypeptide', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Experimental Headache Induced by Vasoactive Intestinal Polypeptide', 'orgStudyIdInfo': {'id': 'VIP-KASGlo2004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'VIP', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup, Copenhagen', 'country': 'Denmark', 'facility': 'Danish Headache Center , KAS Glostrup'}], 'overallOfficials': [{'name': 'Jakob Møller Hansen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Danish Headache Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}}}}