Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2026-04-09 @ 3:27 PM
Study NCT ID:
NCT02066558
Status:
COMPLETED
Last Update Posted:
2015-02-12
First Post:
2014-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbon Monoxide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002248', 'term': 'Carbon Monoxide'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-11', 'studyFirstSubmitDate': '2014-02-17', 'studyFirstSubmitQcDate': '2014-02-18', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache scores', 'timeFrame': '12 h', 'description': 'Comparison between carbon monoxide and placebo (atmospheric air)'}], 'secondaryOutcomes': [{'measure': 'Blood flow velocity', 'timeFrame': '0-180 min after inhalation', 'description': 'Carbon monoxide induced changes in blood flow velocity in the middle cerebral artery before and after inhalation.'}, {'measure': 'Artery circumference', 'timeFrame': '0-180 min', 'description': 'Carbon monoxide induced changes in the superficial temporal artery and the radial artery before and after inhalation.'}, {'measure': 'Facial blood flow', 'timeFrame': '0-180 min', 'description': 'Carbon monoxide induced changes in facial blood flow before and after inhalation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carbon monoxide', 'Headache', 'Migraine'], 'conditions': ['Headache', 'Migraine']}, 'descriptionModule': {'briefSummary': 'In this study the investigators will research the hypothesis that the gas carbon monoxide induces headache and increases the blood flow velocity in the middle cerebral artery.', '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': 'NCT02066558', 'briefTitle': "Carbon Monoxide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow", 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': "Basic Research on Carbon Monoxide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow in a Humane Experimental Headache Model", 'orgStudyIdInfo': {'id': 'H-3-2013-194'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'carbon monoxide', 'description': 'Inhalation of carbon monoxide up to a carboxyhemoglobin concentration of 12% and 22%.', 'interventionNames': ['Other: Carbon monoxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Atmospheric air', 'interventionNames': ['Other: Placebo']}], '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': ['carbon monoxide']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'state': 'Denmark', 'country': 'Denmark', 'facility': 'Danish Headache Center', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Nanna Arngrim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Headache Center, Glostrup Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, medical doctor', 'investigatorFullName': 'Nanna Arngrim', 'investigatorAffiliation': 'Danish Headache Center'}}}}