Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT07021859
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020325', 'term': 'Migraine with Aura'}, {'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'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': 'D002116', 'term': 'Calcitonin'}], 'ancestors': [{'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This single-center trial applies a randomized, double-blind, placebo-controlled, two-way crossover design.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2025-06-06', 'studyFirstSubmitQcDate': '2025-06-06', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of migraine attacks with aura', 'timeFrame': '12 hours', 'description': 'Difference in incidence of migraine attack with aura between CGRP and placebo during the 12-hour observational period after infusion start.'}], 'secondaryOutcomes': [{'measure': 'Incidence of migraine attacks without aura', 'timeFrame': '12 hours', 'description': 'Difference in incidence of migraine headache between CGRP and placebo during the 12-hour observational period after infusion start.'}, {'measure': 'Headache intensity scores', 'timeFrame': '12 hours', 'description': 'Difference in area under the curve (AUC) for headache intensity scores between CGRP and placebo during the 12-hour observational period after infusion start.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine', 'Aura', 'Calcitonin gene-related peptide'], 'conditions': ['Migraine Aura', 'Migraine With Aura']}, 'descriptionModule': {'briefSummary': 'Calcitonin gene-related peptide (CGRP) is a key neuropeptide in migraine pathophysiology and treatment. This study investigates whether CGRP administration can trigger aura in individuals with a diagnosis of migraine with aura.', 'detailedDescription': 'Recent open-label findings show that calcitonin gene-related peptide (CGRP), a key player in migraine, can trigger aura attacks-despite its limited ability to cross the blood-brain barrier. This suggests CGRP might induce migraine aura via trigeminovascular activation, the same pathway involved in migraine headache. If confirmed, this could reshape treatment strategies for patients diagnosed with migraine with aura. To validate this effect and rule out nocebo influence, a randomized, double-blind, placebo-controlled trial is essential. Its outcomes could inform future therapies targeting the migraine-aura connection.'}, '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 migraine with aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria\n* ≥ 1 monthly day with aura that meets criteria as aura on average across the three months before screening\n* Provision of informed consent prior to initiation of any study-specific activities/procedures.\n\nExclusion Criteria:\n\n* Any history of a primary or secondary headache disorder other than migraine without aura, migraine with aura, chronic migraine, and episodic tension-type headache\n* History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, 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* Headache of any intensity within 48 hours of infusion start\n* Aura within 48 hours of infusion start'}, 'identificationModule': {'nctId': 'NCT07021859', 'briefTitle': 'Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'H-23042433'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calcitonin gene-related peptide (CGRP)', 'description': 'CGRP will be administered by intravenous infusion.', 'interventionNames': ['Drug: Calcitonin-gene related peptide (CGRP)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (isotonic saline) will be administered by intravenous infusion.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Calcitonin-gene related peptide (CGRP)', 'type': 'DRUG', 'description': 'The participants will receive a continuous intravenous infusion of 1.5 μg/min of CGRP over 60 minutes.', 'armGroupLabels': ['Calcitonin gene-related peptide (CGRP)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The participants will receive a continuous intravenous infusion of 60 mL of placebo (isotonic saline) over 60 minutes.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Haidar Al-Khazali, MD', 'role': 'CONTACT', 'email': 'haidardk@hotmail.com', 'phone': '+4541598494'}, {'name': 'Hakan Ashina, MD, PhD', 'role': 'CONTACT', 'email': 'haakan.ashina@regionh.dk', 'phone': '+4528102495'}, {'name': 'Haidar Al-Khazali, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rigshospitalet Glostrup', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'centralContacts': [{'name': 'Haidar Al-Khazali, MD', 'role': 'CONTACT', 'email': 'haidardk@hotmail.com', 'phone': '+4541598494'}, {'name': 'Hakan Ashina, MD, PhD', 'role': 'CONTACT', 'email': 'haakan.ashina@regionh.dk', 'phone': '+4528102495'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Anonymized data not published within this article will be made available on reasonable request from any qualified investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Haidar Al-Khazali', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}