Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-31 @ 8:51 AM
Study NCT ID:
NCT05378061
Status:
UNKNOWN
Last Update Posted:
2022-06-22
First Post:
2022-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypersensitivity to PACAP-38 in Post-Traumatic Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051298', 'term': 'Post-Traumatic Headache'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D010146', 'term': 'Pain'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D051219', 'term': 'Pituitary Adenylate Cyclase-Activating Polypeptide'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D009414', 'term': 'Nerve Growth Factors'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium 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': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-18', 'studyFirstSubmitDate': '2022-05-12', 'studyFirstSubmitQcDate': '2022-05-12', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-17', '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 PACAP-38 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 PACAP-38 and placebo.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Headache', 'Pain'], 'conditions': ['Post-Traumatic Headache']}, 'descriptionModule': {'briefSummary': 'The aim is to investigate whether signaling molecule PACAP-38 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': 'NCT05378061', 'briefTitle': 'Hypersensitivity to PACAP-38 in Post-Traumatic Headache', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Hypersensitivity to PACAP-38 in Post-Traumatic Headache: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'H-21048416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PACAP-38', 'description': 'A time- and volume-controlled infusion pump is used to administer PACAP-38 by intravenous infusion over 20 minutes.', 'interventionNames': ['Drug: Pituitary adenylate cyclase activating polypeptide-38']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (isotonic saline)', 'description': 'A time- and volume-controlled infusion pump is used to administer placebo (isotonic saline) by intravenous infusion over 20 minutes.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pituitary adenylate cyclase activating polypeptide-38', 'type': 'DRUG', 'otherNames': ['PACAP-38'], 'description': 'Study participants will be allocated to receive continuous intravenous infusion of 10 pmol/kg/min PACAP-38.', 'armGroupLabels': ['PACAP-38']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Isotonic Saline'], 'description': 'Study participants will be allocated to receive continuous intravenous infusion of 20 mL placebo (isotonic saline).', 'armGroupLabels': ['Placebo (isotonic saline)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Håkan Ashina, MD', 'role': 'CONTACT', 'email': 'haakan.ashina@regionh.dk', 'phone': '+45 28 10 24 95'}], 'facility': 'Danish Headache Center', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Hakan Ashina, MD', 'role': 'CONTACT', 'email': 'haakan.ashina@regionh.dk', 'phone': '00 45 28 10 24 95'}], 'overallOfficials': [{'name': 'Hakan Ashina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Headache Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Håkan Ashina', 'investigatorAffiliation': 'Danish Headache Center'}}}}