Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-05 @ 10:02 PM
Study NCT ID:
NCT02795351
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2016-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction of Migraine Aura With Sildenafil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020325', 'term': 'Migraine with Aura'}], 'ancestors': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'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': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-13', 'studyFirstSubmitDate': '2016-04-09', 'studyFirstSubmitQcDate': '2016-06-06', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aura and migraine like headache', 'timeFrame': '14 hours', 'description': 'Induction of aura reported by an aura diary for 14 hours post medication'}], 'secondaryOutcomes': [{'measure': 'Markers of endothelial function in blood', 'timeFrame': '2 hours'}, {'measure': 'Migraine without aura', 'timeFrame': '14 hours', 'description': 'Induction of headache resembling usual migraine attacks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Migraine With Aura']}, 'referencesModule': {'references': [{'pmid': '35332812', 'type': 'DERIVED', 'citation': 'Butt JH, S Eddelien H, Kruuse C. The headache and aura-inducing effects of sildenafil in patients with migraine with aura. Cephalalgia. 2022 Sep;42(10):984-992. doi: 10.1177/03331024221088998. Epub 2022 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'In a double blind placebo-controlled cross-over study the effect of Sildenafil on aura and migraine headache induction is tested in patient with migraine with aura.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Migraine with aura\n* Minimum of 2 attacks/year\n\nExclusion Criteria:\n\n* Any other type of headache, except tension-type headache \\< 4 days per month\n* History of cardio- or cerebrovascular diseases\n* Hypertension or hypotension\n* Any daily intake of medication, including prophylactic migraine treatment, except oral contraceptives\n* Pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT02795351', 'briefTitle': 'Induction of Migraine Aura With Sildenafil', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'The Effect of the Selective PDE5 Inhibitor, Sildenafil, on Aura and Migraine Headache Induction.', 'orgStudyIdInfo': {'id': 'H-15008491'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'Sildenafil 100 mg single dose', 'interventionNames': ['Drug: Sildenafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsule', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sildenafil', 'type': 'DRUG', 'description': 'Single oral administration of active or placebo one week apart', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Department of Neurology, Herlev-Gentofte Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Christina Kruuse, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, Herlev-Gentofte Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant neurologist, associate professor', 'investigatorFullName': 'Christina Kruuse', 'investigatorAffiliation': 'Herlev Hospital'}}}}