Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide
Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide: A Randomized Clinical Trial
Danish Headache Center
21 participants
Jun 27, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Age 18 to 65 years of age upon entry into screening
- History of migraine with aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria
- ≥ 1 monthly day with aura that meets criteria as aura on average across the three months before screening
- Provision of informed consent prior to initiation of any study-specific activities/procedures.
Exclusion Criteria11
- Any history of a primary or secondary headache disorder other than migraine without aura, migraine with aura, chronic migraine, and episodic tension-type headache
- 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
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
- Female subjects of childbearing potential with a positive pregnancy test during any study visit
- Cardiovascular disease of any kind, including cerebrovascular diseases
- 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
- Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
- Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion
- Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start
- Headache of any intensity within 48 hours of infusion start
- Aura within 48 hours of infusion start
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The participants will receive a continuous intravenous infusion of 1.5 μg/min of CGRP over 60 minutes.
The participants will receive a continuous intravenous infusion of 60 mL of placebo (isotonic saline) over 60 minutes.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07021859