Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT00399633
Status:
COMPLETED
Last Update Posted:
2008-05-14
First Post:
2006-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuropeptides in the Humane Intra- og Extracerebral Circulation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'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': 'D018170', 'term': 'Sumatriptan'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-13', 'studyFirstSubmitDate': '2006-11-14', 'studyFirstSubmitQcDate': '2006-11-14', 'lastUpdatePostDateStruct': {'date': '2008-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood concentration of vasoactive intestinal polypeptide (VIP),'}, {'measure': 'calcitonin gene-related protein (CGRP), pituitary adenylate cyclase'}, {'measure': 'activating peptide (PACAP,) and the prostanoids'}, {'measure': '6-keto-PGF1α, PGE2, PGD2 and PGF2α, sampled from different'}, {'measure': 'venous catheters.'}]}, 'conditionsModule': {'keywords': ['VIP', 'PACAP', 'CGRP', 'Prostanoids'], 'conditions': ['Healthy', 'Migraine']}, 'descriptionModule': {'briefSummary': 'The study aim at examining whether Sumatriptan changes the plasma values of the neuropeptides vasoactive intestinal polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2 og PGF2α.', 'detailedDescription': 'The study is meant to give a better understanding of the basic mechanisms behind migraine, and a better understanding of the effects of sumatriptan on the trigemino vascular system.\n\nThe endpoints are changes in the plasma values of the neuropeptides vasoactive intestinal polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2 og PGF2α.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n* 18-50 years,\n* 50-100 kg.\n* Fertile women must use birth control.\n\nExclusion Criteria:\n\n* All primary types of headache\n* Daily intake of medicine except birth control\n* Pregnancy\n* Hypertension\n* Hypotension\n* other chronic disease'}, 'identificationModule': {'nctId': 'NCT00399633', 'briefTitle': 'Neuropeptides in the Humane Intra- og Extracerebral Circulation.', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Neuropeptides in the Humane Intra- og Extracerebral Circulation - in Relation to Sumatriptan in Healthy Volunteers.', 'orgStudyIdInfo': {'id': 'Neuropeptide2007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sumatriptan', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup, Copenhagen', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Danish Headache Center'}], 'overallOfficials': [{'name': 'Jakob Møller Hansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Headache Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}]}}}