Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-27 @ 11:24 PM
Study NCT ID:
NCT04217668
Status:
COMPLETED
Last Update Posted:
2021-03-25
First Post:
2020-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Headache Provocation of People Who Are Unable to Have Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C030397', 'term': 'isosorbide-5-mononitrate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The investigators are blinded to the case-control grouping of the participants.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Blinded case-control study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-24', 'studyFirstSubmitDate': '2020-01-02', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve of headache intensity', 'timeFrame': '5 hours', 'description': 'Area under the curve of headache intensity from 0 - 5 hours post tablet administration'}], 'secondaryOutcomes': [{'measure': 'Area under the curve of headache intensity', 'timeFrame': '12 hours', 'description': 'Area under the curve of headache intensity from 0 - 12 hours post tablet administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Headache', 'Healthy']}, 'descriptionModule': {'briefSummary': 'Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in Europe. Despite this high prevalence, there are persons who have never, in their whole life, encountered a headache.\n\nThe aim of the study is to identify factors that protect against headache by studying headache after provocation in people who never have had a headache (headache resistant) versus non-resistant controls.\n\nThe investigators will use isosorbide mononitrate as a pharmacological trigger of headache. The provocation is performed by investigators who are blinded to the grouping of the participants.\n\nThe investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Headache resistant and non-resistant male participants from the Danish Blood Donor Study.\n* Weight: 45 kg to 95 kg\n\nExclusion Criteria:\n\n* Daily consumption of any medication.\n* Consumption of any medication less than 12 hours prior to the study day.\n* Headache on the study day or 48 hours prior to the study day.\n* Amnestic or clinical signs of hypertension (systolic blood pressure \\>150 mmHg and/or diastolic blood pressure \\>100 mmHg) or hypotension (systolic blood pressure \\<90 mmHg and/or diastolic blood pressure \\<50 mmHg).\n* Any severe cardiovascular disease, including cerebrovascular illness.\n* Amnestic or clinical signs of current mental illness.\n* Amnestic or clinical signs of current substance or drug abuse.\n* Amnestic or clinical signs of any illness the responsible doctor considers relevant for participation in the study.'}, 'identificationModule': {'nctId': 'NCT04217668', 'briefTitle': 'Headache Provocation of People Who Are Unable to Have Headache', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache', 'orgStudyIdInfo': {'id': 'HR002 Provocation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Isosorbide mononitrate', 'description': 'Cases and controls both receive one tablet Imdur® 60 mg (isosorbide mononitrate) on the study day.', 'interventionNames': ['Drug: Isosorbide Mononitrate 60 MG']}], 'interventions': [{'name': 'Isosorbide Mononitrate 60 MG', 'type': 'DRUG', 'otherNames': ['Imdur'], 'description': '1 tablet Isosorbide Mononitrate 60 mg administrated orally.', 'armGroupLabels': ['Isosorbide mononitrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'state': 'Region H', 'country': 'Denmark', 'facility': 'Danish Headache Center', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Jes Olesen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Danish Headache Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, PhD student', 'investigatorFullName': 'Isa Amalie Olofsson', 'investigatorAffiliation': 'Danish Headache Center'}}}}