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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form prior to initiation of any study-specific activities/procedures. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (1)

Rigshospitalet Glostrup
Glostrup Municipality, Denmark