NCT07021859

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Danish Headache Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Migraine Aura
• Migraine With Aura

Interventions

Type	Name	Description
DRUG	Calcitonin-gene related peptide (CGRP)	The participants will receive a continuous intravenous infusion of 1.5 μg/min of CGRP over 60 minutes.
DRUG	Placebo	The participants will receive a continuous intravenous infusion of 60 mL of placebo (isotonic saline) over 60 minutes.

Timeline

• Start date: 2025-06-27
• Primary completion: 2026-06-01
• Completion: 2026-12-30
• First posted: 2025-06-15
• Last updated: 2025-08-06

Locations

1 site across 1 country: Denmark