Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-30 @ 12:56 PM
Study NCT ID:
NCT05595993
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2022-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051298', 'term': 'Post-Traumatic Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'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': 'D000077407', 'term': 'Cilostazol'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, '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': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-04', 'studyFirstSubmitDate': '2022-10-23', 'studyFirstSubmitQcDate': '2022-10-23', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Migraine-Like Headache', 'timeFrame': '12 Hours', 'description': 'Difference in incidence of headache with migraine-like features (0 to 12 hours) between cilostazol and placebo.'}], 'secondaryOutcomes': [{'measure': 'Headache Intensity Scores', 'timeFrame': '12 Hours', 'description': 'Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between cilostazol and placebo.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-Traumatic Headache']}, 'referencesModule': {'references': [{'pmid': '38627631', 'type': 'DERIVED', 'citation': 'Al-Khazali HM, Christensen RH, Chaudhry BA, Melchior AG, Ashina M, Burstein R, Ashina H. Effects of PDE-3 inhibition in persistent post-traumatic headache: evidence of cAMP-dependent signaling. J Headache Pain. 2024 Apr 17;25(1):56. doi: 10.1186/s10194-024-01762-x.'}]}, 'descriptionModule': {'briefSummary': 'To investigate whether cilostazol (phosphodiesterase 3 inhibitor) induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 to 65 years of age upon entry into screening\n* History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)\n* ≥ 4 monthly headache days on average across the 3 months prior to screening\n* Provision of informed consent prior to initiation of any study-specific activities/procedures.\n\nExclusion Criteria:\n\n* \\> 1 mild traumatic injury to the head\n* History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache)\n* History of moderate or severe injury to the head\n* History of whiplash injury\n* History of craniotomy\n* History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion\n* The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior\n* Female subjects of childbearing potential with a positive pregnancy test during any study visit\n* Cardiovascular disease of any kind, including cerebrovascular diseases\n* Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day\n* Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)\n* Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion\n* Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start\n* Baseline headache intensity of \\>3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache)\n* Baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features"}, 'identificationModule': {'nctId': 'NCT05595993', 'briefTitle': 'Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'H-21067676'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cilostazol', 'description': 'Oral administration of 200 mg cilostazol.', 'interventionNames': ['Drug: Cilostazol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cilostazol', 'type': 'DRUG', 'description': 'Study participants will be allocated to receive oral administration of 200 mg cilostazol.', 'armGroupLabels': ['Cilostazol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Study participants will be allocated to receive oral administration of placebo.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Hakan Ashina, MD', 'role': 'CONTACT'}], 'facility': 'Danish Headache Center', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Hakan Ashina, MD', 'role': 'CONTACT', 'email': 'haakan.ashina@regionh.dk', 'phone': '+4528102495'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Håkan Ashina', 'investigatorAffiliation': 'Danish Headache Center'}}}}