Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-30 @ 11:46 PM
Study NCT ID:
NCT04232605
Status:
UNKNOWN
Last Update Posted:
2020-01-18
First Post:
2020-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon Like Peptide-1 in Humans
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': 'C000623226', 'term': 'glucagon-like peptide 1 (7-37)-proline, glycyl(2)-'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Phase one: In a randomized, single-blind, multiple-ascending-dose finding pilot study we investigate the safety and tolerability of GLP-1 on three healthy volunteers. The following GLP-1 doses will be given intravenously ( 1.5, 2.0 and 2.5 picomol/kg/min) over 20 min. The dose with considerable dilatory effect will be chosen for main study.\n\nPhase 2 and 3:The study is a double-blinded, placebo-controlled, randomized crossover study. It involves two arms, GLP-1 and placebo. Each participant will in a randomized order receive placebo or GLP-1 intravenous infusion over 20 min on the two experiment days.\n\nThe study consists of two separate substudies, one for healthy volunteers and one for migraine patients. The substudies are otherwise identical.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-15', 'studyFirstSubmitDate': '2020-01-09', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vasodilation', 'timeFrame': '120 minutes', 'description': 'Difference in circumference (in millimeter) of intra - and extracranial blood vessels before and after GLP-1 or placebo infusion, measured by transcranial doppler and ultrasound (Derma scan) at 10 specific time points (-10, 10, 20, 30, 40, 50, 60, 80, 100, and 120 minutes)'}, {'measure': 'Headache intensity', 'timeFrame': '12 hours', 'description': 'Headache intensity will be measured using Numerical rating scale (NRS) from ( 0 to 10 )'}], 'secondaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': '120 minutes', 'description': 'Blood pressure (systolic and diastolic) in mmhg will be measured every 10 minutes'}, {'measure': 'Facial skin perfusion', 'timeFrame': '120 minutes', 'description': 'Non-invasive measuring of facial skin perfusion by laser speckle contrast imager.'}, {'measure': 'Heart rate', 'timeFrame': '120 minutes', 'description': 'heart rate will be measured every 10 minutes'}, {'measure': 'Plasma glucose', 'timeFrame': '120 minutes', 'description': 'Plasma glucose will be measured using (mmol/L) a ABL Radiometer, Denmark Blood-gas analyser'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Headache, Migraine']}, 'descriptionModule': {'briefSummary': 'Studying glucagon-like peptide-1 (GLP-1) induced vasodilatory effects on extra - and intracerebral arteries and headache in healthy volunteers and migraine patients without aura.', 'detailedDescription': 'The purpose of this study is to examine the association between vasodilation and intensity of headache triggered by glucagon-like peptide 1 (GLP-1) in healthy volunteers and migraine patients without aura.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Criteria for the healthy volunteers group\n\nInclusion Criteria:\n\n* Healthy men/women.\n* Age 18 to 60 years old.\n* Weight 50 to 100 kg.\n\nExclusion Criteria:\n\n* Tension headache more than 5 days a month in the preceding year.\n* All other primary headache types.\n* Headache on the examination day or within 48 hours before infusion of the study drug.\n* Smoking.\n* Daily intake of medicine of any kind except for peroral contraceptives.\n* Women, who on the day of examination is 2 days before or 3 days from the first day of bleeding.\n* Hypertension or hypotension.\n* Coronary heart disease of any kind, as well as cerebrovascular disease.\n* Pulmonary disease.\n* Allergy to contents in the study drug.\n* Psychiatric disease or substance abuse.\n* Disease of any kind which the examining doctor deems relevant for participation in the study.\n* Renouncing the right to information concerning own health.\n\nCriteria for the migraine patients group\n\nInclusion Criteria:\n\n* Migraine patients, who fulfill the ICHD-3 criteria for migraine without aura.\n* Age 18 to 60 years old.\n* Weight 50 to 100 kg.\n\nExclusion Criteria:\n\n* Tension headache more than 5 days a month in the preceding year.\n* All other primary headache types.\n* Headache on the examination day or within 48 hours before infusion of the study drug.\n* Smoking.\n* Daily intake of medicine of any kind except for peroral contraceptives.\n* Women, who on the day of examination is 2 days before or 3 days from the first day of bleeding.\n* Hypertension or hypotension.\n* Coronary heart disease of any kind, as well as cerebrovascular disease.\n* Pulmonary disease.\n* Allergy to contents in the study drug.\n* Psychiatric disease or substance abuse.\n* Disease of any kind which the examining doctor deems relevant for participation in the study.\n* Renouncing the right to information concerning own health.'}, 'identificationModule': {'nctId': 'NCT04232605', 'briefTitle': 'Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon Like Peptide-1 in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon-like Peptide-1 in Healthy Volunteers and Migraine Patients', 'orgStudyIdInfo': {'id': 'H-19037051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GLP-1', 'description': 'Receive intravenous infusion of GLP-1.', 'interventionNames': ['Other: GLP-1 peptide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Receive intravenous infusion of saline.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'GLP-1 peptide', 'type': 'OTHER', 'description': 'Receive intravenous infusion of GLP-1. The dosage will be determined after a dose finding pilot study.', 'armGroupLabels': ['GLP-1']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Receive intravenous infusion saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Dansk Hovedpinecenter', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'centralContacts': [{'name': 'Hashmat Ghanizada, MD', 'role': 'CONTACT', 'email': 'hashmat.ghanizada@regionh.dk', 'phone': '38633470'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Hashmat Ghanizada', 'investigatorAffiliation': 'Danish Headache Center'}}}}