Hypersensitivity to Amylin in Post-Traumatic Headache

What Was Tested

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

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

To test this hypothesis, the researchers will conduct a randomized, double-blind, placebo-controlled, two-way crossover study.

Who Took Part

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. Provision of informed consent prior to initiation of any study-specific activities/procedures.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: \> 1 mild traumatic injury to the head; history of moderate or severe injury to the head; history of whiplash injury.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

Because people in this Amylin (Islet Amyloid Polypeptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Amylin (Islet Amyloid Polypeptide) and the comparison at some point, usually with a gap in between.

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 2028-12.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What This Means in Plain Language

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

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, all human trials.