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

NCT ID: NCT07021859

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-27

Study Completion Date

2026-12-30

Brief Summary

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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

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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

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Migraine Aura Migraine With Aura

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This single-center trial applies a randomized, double-blind, placebo-controlled, two-way crossover design.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Calcitonin gene-related peptide (CGRP)

CGRP will be administered by intravenous infusion.

Group Type EXPERIMENTAL

Calcitonin-gene related peptide (CGRP)

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Calcitonin-gene related peptide (CGRP)

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Haidar Al-Khazali

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rigshospitalet Glostrup

Glostrup Municipality, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Haidar Al-Khazali, MD

Role: CONTACT

+4541598494

Hakan Ashina, MD, PhD

Role: CONTACT

+4528102495

Facility Contacts

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Haidar Al-Khazali, MD

Role: primary

+4541598494

Hakan Ashina, MD, PhD

Role: backup

+4528102495

Other Identifiers

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H-23042433

Identifier Type: -

Identifier Source: org_study_id

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