Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-15 @ 2:39 AM
Study NCT ID:
NCT03075020
Status:
COMPLETED
Last Update Posted:
2017-12-21
First Post:
2017-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbon Monoxide Migraine-inducing Effects in Patients With Migraine Without Aura.
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': 'D002248', 'term': 'Carbon Monoxide'}, {'id': 'D000388', 'term': 'Air'}], 'ancestors': [{'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-20', 'studyFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2017-03-06', 'lastUpdatePostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache scores, 12 hours', 'timeFrame': '12 hours', 'description': 'Comparison between carbon monoxide and placebo (atmospheric air)'}], 'secondaryOutcomes': [{'measure': 'Facial blood flow', 'timeFrame': '[ Time Frame: 0-180 min ]', 'description': 'Carbon monoxide induced changes in facial blood flow before and after inhalation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Headache, Migraine']}, 'descriptionModule': {'briefSummary': 'To investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide.', 'detailedDescription': 'To investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide.\n\nWith transcranial Doppler imaging, c-scan and laser speckle the investigators will investigate changes in blood flow velocity of the middle cerebral artery (MCA), diameter of the superficial temporal artery (STA), the radial artery and facial skin perfusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* Aged 18-50\n* 50-100 kg\n\nExclusion Criteria:\n\n* Tension type headache more than once/month\n* Other primary headaches\n* Daily medication except contraceptives\n* Drug taken within 4 times the halflife for the specific drug except contraceptives\n* Pregnant or lactating women\n* Exposure to radiation within the last year\n* Headache within the last 24 hours before start of trial\n* Hypertension\n* Hypotension\n* Respiratory or cardiac disease\n* Smoking\n* Primary relatives with current or previous migraine'}, 'identificationModule': {'nctId': 'NCT03075020', 'briefTitle': 'Carbon Monoxide Migraine-inducing Effects in Patients With Migraine Without Aura.', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': "Basic Research on Carbon Monoxide's Headache Inducing Characteristics in a Humane Experimental Headache Model", 'orgStudyIdInfo': {'id': 'H-16021497'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active carbon monoxide', 'description': 'Inhalation of carbon monoxide up to a carboxyhemoglobin concentration 22%', 'interventionNames': ['Other: Carbon monoxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Air', 'interventionNames': ['Other: AIR']}], 'interventions': [{'name': 'Carbon monoxide', 'type': 'OTHER', 'description': 'carbon monoxide, 4.7, Purity 99.997, inhalation of carbon monoxide in a volume corresponding to carboxyhemoglobin 10 and 20%, calculated from baseline Hg and body mass', 'armGroupLabels': ['Active carbon monoxide']}, {'name': 'AIR', 'type': 'OTHER', 'description': 'Room air will be administered as placebo', 'armGroupLabels': ['Air']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Danish Headache Center', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Hashmat Ghanizada', 'investigatorAffiliation': 'Danish Headache Center'}}}}