Adrenomedullin Effect on Migraine Without Patients

What Was Tested

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

AM is a naturally occurring peptide in the body and consists of 52 amino acids.

In a randomized double-blind, placebo controlled cross-over design 20 migraine patients without aura recruited to receive infusion of adrenomedullin or placebo (saline).

It had two arms (groups): Adrenomedullin (active comparator) and Saline (placebo comparator).

Saline.

The registry classes the interventions as other.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: 18-60 years old.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: daily intake of medicines of all kinds except oral contraception; taking any medicine later than 4 times the plasma half-life of that drug (on the day of the trial), except oral contraception; pregnant or breastfeeding women.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

The migraine participants were allocated by chance, so the Adrenomedullin group and the comparison group should start out alike.

Each person switched between Adrenomedullin and the comparison at some point, usually with a gap in between.

As a double-blind Adrenomedullin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2019-09-28 with completion listed for 2020-01-30.

It ran at 1 site in Denmark.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Migraine incidance after infusion of adrenomedullin compared to placebo (time frame: 0-12 hours).

It also tracked 2 secondary outcomes, for example Change in puls, MAP and facial flushing.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Adrenomedullin in 20 people with migraine.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Adrenomedullin compound page, Migraine research.