Endothelin-1 as a Potential Trigger of Migraine Aura

What Was Tested

The trial (not phased) is built around Endothelin-1 for migraine.

One third of migraine patients experience aura, i.e. dramatic, transient neurological symptoms, most often in the form of visual disturbances, that usually appear before the onset of migraine headache.

The likely underlying mechanism of aura is known as cortical spreading depression, a wave of changes in electrical activity that slowly spreads in the outermost layer of the brain.

It had two arms (groups): Endothelin-1 (experimental) and Placebo (placebo comparator).

Intravenous infusion of placebo (isotonic saline).

The registry classes the interventions as drug.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age between 18 and 40 years. Diagnosis of migraine with typical aura (patient group only). Attacks of migraine with aura at least once per month on average (patient group only). No history or family history of migraine (healthy subject group only).

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: tension-type headache more than one day per month on average; any other primary headache disorder; daily intake of medication.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Endothelin-1 and who got the comparison, which limits bias.

Each person switched between Endothelin-1 and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the migraine participants and researchers unaware of who received Endothelin-1.

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

It started in 2016-10 with completion listed for 2018-05.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Occurrence of migraine aura (time frame: 0-24 hours).

It also tracked 3 secondary outcomes, for example Cerebral vasoconstriction: MR angiography, Change in cerebral blood flow: Phase contrast mapping and Change in cerebral blood flow: Arterial spin labeling.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Endothelin-1 in 60 people with migraine.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Endothelin-1 compound page, Migraine research.