Actively Recruiting
Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide: A Randomized Clinical Trial
Led by Danish Headache Center · Updated on 2025-08-06
21
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether administration of calcitonin gene-related peptide (CGRP), an important neuropeptide involved in migraine, can trigger migraine aura in people diagnosed with migraine with aura. This study aims to confirm prior findings that CGRP can cause aura attacks despite limited ability to cross the blood-brain barrier, suggesting a role of trigeminovascular activation in migraine aura. The trial is randomized, double-blind, and placebo-controlled to validate this effect and eliminate placebo influence, potentially influencing future migraine treatments. Participants will receive either a continuous intravenous infusion of CGRP at 1.5 micrograms per minute for 60 minutes or a placebo infusion of isotonic saline over the same duration. The study has two groups: one receiving CGRP and the other receiving placebo, both administered by intravenous infusion. The trial begins with screening and continues with the infusion on the experimental day under close monitoring. During the study, participants are monitored for migraine attacks with aura and without aura over a 12-hour period after infusion. Researchers will assess headache intensity scores and record the incidence of migraine attacks. Safety is closely observed, and participants will provide informed consent before starting. The study runs until late 2026, with participation lasting through screening, infusion, and post-infusion monitoring periods.
CONDITIONS
Brief Title
Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years of age upon entry into screening
- History of migraine with aura for at least 12 months according to the International Classification of Headache Disorders 3rd Edition criteria
- At least 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 or procedures
You will not qualify if you...
- History of any primary or secondary headache disorder other than migraine without aura, migraine with aura, chronic migraine, or episodic tension-type headache
- Any other clinically significant disorder or disease that may pose a risk to safety or interfere with study procedures
- 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 with systolic blood pressure of 150 mmHg or higher and/or diastolic blood pressure of 100 mmHg or higher prior to infusion start
- Hypotension with systolic blood pressure of 90 mmHg or lower and/or diastolic blood pressure of 50 mmHg or lower
- Changes in prophylactic medication dosing within 2 months before study inclusion
- Use of acute medications such as analgesics or triptans within 48 hours before infusion start
- Headache of any intensity within 48 hours before infusion start
- Aura within 48 hours before infusion start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single infusion session with 12 hours of monitoring
Participants receive an intravenous infusion of either CGRP or placebo over 60 minutes to induce migraine attacks with aura.
1 infusion visit and observation for 12 hours
Trial Site Locations
Total: 1 location
1
Rigshospitalet Glostrup
Glostrup Municipality, Denmark, 2600
Actively Recruiting
Research Team
H
Haidar Al-Khazali, MD
H
Hakan Ashina, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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