An interventional study of Calcitonin-gene related peptide (CGRP) and Placebo in Migraine Aura and Migraine With Aura, sponsored by Danish Headache Center. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by Danish Headache Center · Not applicable, Interventional, and Basic science
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.
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.
114 studies on the registry are indexed under Migraine with Aura; 22 are open to participants now.
This study's planned enrollment of 21 is below the median of 89 across 86 interventional studies indexed under Migraine with Aura.
Browse Migraine with Aura studies →Danish Headache Center is the lead sponsor of 129 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CGRP will be administered by intravenous infusion.
Drug: Calcitonin-gene related peptide (CGRP)
Placebo (isotonic saline) will be administered by intravenous infusion.
Drug: Placebo
The participants will receive a continuous intravenous infusion of 1.5 μg/min of CGRP over 60 minutes.
The participants will receive a continuous intravenous infusion of 60 mL of placebo (isotonic saline) over 60 minutes.
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.
Time frame: 12 hours
Incidence of migraine attacks without aura
Difference in incidence of migraine headache between CGRP and placebo during the 12-hour observational period after infusion start.
Time frame: 12 hours
Headache intensity scores
Difference in area under the curve (AUC) for headache intensity scores between CGRP and placebo during the 12-hour observational period after infusion start.
Time frame: 12 hours
Plan to share: Yes — Anonymized data not published within this article will be made available on reasonable request from any qualified investigator.
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jun 2026, 11 months after the start.
Of 23 interventional studies with no phase under Migraine with Aura, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 34. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Calcitonin Gene-Related Peptide