Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide
NCT ID: NCT07021859
Last Updated: 2025-08-06
Study Results
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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RECRUITING
NA
21 participants
INTERVENTIONAL
2025-06-27
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Calcitonin gene-related peptide (CGRP)
CGRP will be administered by intravenous infusion.
Calcitonin-gene related peptide (CGRP)
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.
Placebo
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.
Placebo
The participants will receive a continuous intravenous infusion of 60 mL of placebo (isotonic saline) over 60 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Danish Headache Center
OTHER
Responsible Party
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Haidar Al-Khazali
Principal Investigator
Locations
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Rigshospitalet Glostrup
Glostrup Municipality, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-23042433
Identifier Type: -
Identifier Source: org_study_id
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