Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide

Launched by DANISH HEADACHE CENTER · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a substance called calcitonin gene-related peptide (CGRP) might trigger migraine aura in people who experience migraines with aura. Aura is a set of symptoms that can occur before or during a migraine, such as visual disturbances. The goal is to understand better how CGRP plays a role in these migraines, which could help in developing new treatments.

To participate in this study, you need to be between 18 and 65 years old and have a history of migraines with aura for at least a year. You should experience aura at least once a month. If you meet these criteria, you might be eligible to join the trial. Participants will receive CGRP and will be monitored for any changes in their migraine symptoms. It's important to know that certain health conditions and recent treatments could prevent you from joining the study, so be sure to discuss your medical history with the research team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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