An interventional study of Amylin and Placebo in Headache Disorders, Primary, Headache Disorders and Brain Diseases, sponsored by Danish Headache Center. Not yet recruiting at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Danish Headache Center · Not applicable, Interventional, and Basic science
Pramlintide is a peptide analogue of human amylin which is a vasoactive signaling molecule involved in the pathogenesis of migraine. This study investigates whether pramlintide induces migraine attacks without aura in people with migraine without aura.
Amylin is a vasoactive substance that acts on vascular smooth muscle and can cause vasodilation. It is naturally present in the trigeminovascular system, an important structure involved in headache development. Recent studies indicate that intravenous infusion of pramlintide, an amylin analogue, can trigger migraine attacks in people with migraine. This study aims to determine whether intravenous pramlintide can induce migraine attacks without aura in individuals who experience migraine without aura. To test this, the investigators will conduct a randomized, double-blind, placebo-controlled, two-way crossover trial.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 21 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Danish Headache Center is the lead sponsor of 129 studies on the registry; 15 are open to participants now.
Compared within Migraine Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Headache Disorders, Primary. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pramlintide (Amylin) will be administered by intravenous infusion.
Drug: Amylin
Placebo (isotonic saline) will be administered by intravenous infusion.
Drug: Placebo
The participants will receive continuous intravenous infusion of 20 mL (6 μg/min) of pramlintide (amylin) over 20 minutes.
The participants will receive continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.
Incidence of migraine attacks without aura
The difference in the incidence of migraine attacks without aura between pramlintide and placebo during the 12-hour observational period after infusion start.
Time frame: 12 hours
Headache intensity scores
The secondary outcome is the difference in the area under the curve (AUC) for median headache intensity scores between pramlintide and placebo during the 12-hour observational period after infusion start.
Time frame: 12 hours
Superficial temporal artery dilation
The difference in AUC for relative superficial temporal artery (STA) dilation between pramlintide and placebo from the start of infusion to 2 hours after the infusion.
Time frame: 2 hours
Middle cerebral artery blood flow velocity
The difference in AUC for change in middle cerebral artery (MCA) mean blood flow velocity between pramlintide and placebo from the start of infusion to 2 hours after the infusion.
Time frame: 2 hours
Plan to share: Yes
Access criteria: Anonymized data not published within this article will be made available on reasonable request from any qualified investigator.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Islet Amyloid Polypeptide