Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 7:15 PM
Study NCT ID:
NCT04218760
Status:
COMPLETED
Last Update Posted:
2021-03-25
First Post:
2020-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiomics After 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'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Case-control study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-24', 'studyFirstSubmitDate': '2020-01-03', 'studyFirstSubmitQcDate': '2020-01-03', 'lastUpdatePostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transcriptomic changes', 'timeFrame': '5 hours', 'description': 'Difference in RNA expression between cases and controls after headache provocation by Isosorbide Mononitrate.'}, {'measure': 'Metabolomic changes', 'timeFrame': '5 hours', 'description': 'Difference in metabolites between cases and controls after headache provocation by Isosorbide Mononitrate.'}]}, '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 multiomics in people who never have had a headache (headache resistant) versus non-resistant controls.\n\nThe investigators will measure multiomic changes (transcriptomics and metabolomics) after headache provocation with isosorbide mononitrate. 3 blood samples, two for RNA and one for metabolomics are taken right before administration of isosorbide mononitrate, 3 hours after administration of isosorbide mononitrate and again 5 hours after administration of isosorbide mononitrate.\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': 'NCT04218760', 'briefTitle': 'Multiomics After 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': 'HR003 Multiomics 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 and have 3 sets of blood samples drown.', 'interventionNames': ['Drug: Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]', 'Other: Blood sample']}], 'interventions': [{'name': 'Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]', 'type': 'DRUG', 'description': '1 tablet Isosorbide Mononitrate 60 mg administrated orally.', 'armGroupLabels': ['Isosorbide mononitrate']}, {'name': 'Blood sample', 'type': 'OTHER', 'description': '3 blood samples from a periferal vein, two for RNA and one for metabolomics are taken right before administration of isosorbide mononitrate, 3 hours after administration of isosorbide mononitrate and again 5 hours after administration of isosorbide mononitrate.', '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': 'Principal Investigator', 'investigatorFullName': 'Isa Amalie Olofsson', 'investigatorAffiliation': 'Danish Headache Center'}}}}