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

NCT07021859 | Recruiting

• 1 other identifier: H-23042433
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine Aura; Migraine With Aura

Keywords

Migraine; Aura; Calcitonin gene-related peptide

Outcome Measures

Primary Outcomes (1)

• Incidence of migraine attacks with aura

  Difference in incidence of migraine attack with aura between CGRP and placebo during the 12-hour observational period after infusion start.

  12 hours

Secondary Outcomes (2)

• Incidence of migraine attacks without aura

  12 hours

• Headache intensity scores

  12 hours

Study Arms (2)

Calcitonin gene-related peptide (CGRP)

EXPERIMENTAL

CGRP will be administered by intravenous infusion.

Drug: Calcitonin-gene related peptide (CGRP)

Placebo

PLACEBO COMPARATOR

Placebo (isotonic saline) will be administered by intravenous infusion.

Drug: Placebo

Interventions

Calcitonin-gene related peptide (CGRP) DRUG

The participants will receive a continuous intravenous infusion of 1.5 μg/min of CGRP over 60 minutes.

Calcitonin gene-related peptide (CGRP)

Placebo DRUG

The participants will receive a continuous intravenous infusion of 60 mL of placebo (isotonic saline) over 60 minutes.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Migraine with Aura; Migraine Disorders; Epilepsy

Interventions

Calcitonin

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroid Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Central Study Contacts

Haidar Al-Khazali, MD

CONTACT

+4541598494; haidardk@hotmail.com

Hakan Ashina, MD, PhD

CONTACT

+4528102495; haakan.ashina@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This single-center trial applies a randomized, double-blind, placebo-controlled, two-way crossover design.

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)