Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-01 @ 3:13 PM
Study NCT ID:
NCT04960657
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2021-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D010146', 'term': 'Pain'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005905', 'term': 'Glyburide'}, {'id': 'D051219', 'term': 'Pituitary Adenylate Cyclase-Activating Polypeptide'}], 'ancestors': [{'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009414', 'term': 'Nerve Growth Factors'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-02', 'studyFirstSubmitDate': '2021-05-24', 'studyFirstSubmitQcDate': '2021-07-02', 'lastUpdatePostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache', 'timeFrame': 'Time of headache measurements is from before (-20 minutes) and up to 12 hours after PACAP38 infusion', 'description': 'Headache intensity will be recorded by numerical rating scale (NRS) from 0 to 10 (0, no headache; 1, a feeling of pressure; 10, worst imaginable headache).'}], 'secondaryOutcomes': [{'measure': 'Changes in the arterial radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA).', 'timeFrame': 'Time of measurements is baseline and repeatedly every 20 minutes for 260 minutes.', 'description': 'Repeated measurements covering the diameter of RA, STA and MCA before and after PACAP38 infusion and glibenclamide/placebo administration measured by centimeter (cm)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glyburide', 'Physiological Effects of Drugs', 'Hypoglycemic Agents'], 'conditions': ['Migraine', 'Headache', 'Pain']}, 'descriptionModule': {'briefSummary': 'To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.', 'detailedDescription': '22 healthy participants will randomly be allocated to receive PACAP38 infusion followed by glibenclamide or placebo on two different days.\n\nThe aim of the study is to investigate the vascular effect of PACAP38 after glibenclamide administration.\n\nRepeated measurements covering the arteria radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after PACAP38 infusion and glibenclamide/placebo administration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers of both sexes.\n* 18-60 years.\n* 50-100 kg.\n* Women of childbearing age must use adequate contraception\n\nExclusion Criteria:\n\n* A history of serious somatic or psychiatric disease\n* Migraine or any other type of headache (except episodic tension-type headache less than 5 days per month)\n* Daily intake of any medication except contraceptives'}, 'identificationModule': {'nctId': 'NCT04960657', 'briefTitle': 'The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'H19065735'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PACAP38 and glibenclamide', 'description': 'Participants will receive glibenclamide after PACAP38 infusion', 'interventionNames': ['Drug: glibenclamide', 'Drug: PACAP38']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PACAP38 and placebo', 'description': 'Participants will receive placebo after PACAP38 infusion', 'interventionNames': ['Drug: glibenclamide', 'Drug: PACAP38']}], 'interventions': [{'name': 'glibenclamide', 'type': 'DRUG', 'description': 'Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration .', 'armGroupLabels': ['PACAP38 and glibenclamide', 'PACAP38 and placebo']}, {'name': 'PACAP38', 'type': 'DRUG', 'otherNames': ['Pituitary adenylate cyclase activating polypeptide-38'], 'description': 'PACAP38 infusion', 'armGroupLabels': ['PACAP38 and glibenclamide', 'PACAP38 and placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Copenhagen', 'state': 'Capital Region', 'country': 'Denmark', 'facility': 'Danish Headache Center', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD student, Principal investigator', 'investigatorFullName': 'Lili Kokoti', 'investigatorAffiliation': 'Danish Headache Center'}}}}