Hypersensitivity to Adrenomedullin in Post-Traumatic Headache

What Was Tested

In this not phased trial, researchers set out to test Adrenomedullin.

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

Adrenomedullin 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

Adrenomedullin is a potent vasoactive peptide that acts on the vascular smooth muscle and is known to induce vasodilation.

To test this hypothesis, the investigators will carry out a randomized, double-blind, placebo-controlled, two-way crossover trial.

Who Took Part

The registry lists 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.

Random assignment meant chance, not the researchers, decided who got Adrenomedullin and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Adrenomedullin and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Adrenomedullin, so expectations could not easily colour the readings.

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

It started in 2025-08-01 with completion listed for 2028-05-01.

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 Adrenomedullin in 21 people.

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

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Adrenomedullin compound page, all human trials.