Amylin-Induced Migraine Attacks Without Aura

What Was Tested

The trial (not phased) is built around Amylin (Islet Amyloid Polypeptide) for migraine.

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.

It had two arms (groups): Amylin (experimental) and Placebo (placebo comparator).

Pramlintide (Amylin) will be administered by intravenous infusion.

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

The registry classes the interventions as drug.

More on the Plan

Amylin is a vasoactive substance that acts on vascular smooth muscle and can cause vasodilation.

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.

Who Took Part

Enrollment: 21 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18 to 65 years of age upon entry into screening. A body weight of 50 to 100 kg. History of migraine without aura for ≥12 months and in accordance with ICHD-3. Between 1-5 monthly migraine days without aura on average across the 3 months prior to screening. Provision of informed consent prior to initiation of any study-specific activities/procedures.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: any history of moderate to severe traumatic brain injury; any history of cardiovascular disease, including cerebrovascular diseases; any history of pulmonary disease.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

The migraine participants were allocated by chance, so the Amylin (Islet Amyloid Polypeptide) group and the comparison group should start out alike.

In the crossover set-up each of the migraine participants took both Amylin (Islet Amyloid Polypeptide) and the comparison in turn, acting as their own control.

As a double-blind Amylin (Islet Amyloid Polypeptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-02 with completion listed for 2028-10-30.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Incidence of migraine attacks without aura (time frame: 12 hours).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Amylin (Islet Amyloid Polypeptide) in 21 people with migraine.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Amylin (Islet Amyloid Polypeptide) compound page, Migraine research.