Pharmacologically Triggered Migraine Without Aura and Neuroimaging

What Was Tested

In this not phased trial, researchers set out to test CGRP (Calcitonin Gene-Related Peptide) for migraine.

One of the most fundamental questions of migraine, which remains to be elucidated, is the mechanism behind the generation of migraine attacks.

It had three arms (groups): CGRP (experimental), Sildenafil (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 36 planned participants were the target.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Age between 18 and 50 years. Weight: 50-100 kg. Diagnosis of migraine without aura (patient group only). Attacks of migraine without aura at least once every second month (patient group only).

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: history or family history of migraine (healthy subject group only); daily intake of medication (apart from oral contraceptives); intake of any medication less than 4 half-lives before study start.

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 CGRP (Calcitonin Gene-Related Peptide) and who got the comparison, which limits bias.

In the crossover set-up each of the migraine participants took both CGRP (Calcitonin Gene-Related Peptide) and the comparison in turn, acting as their own control.

As a double-blind CGRP (Calcitonin Gene-Related Peptide) 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 2016-08 with completion listed for 2018-12.

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 CGRP (Calcitonin Gene-Related Peptide) in 36 people with migraine.

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

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

More context: the CGRP (Calcitonin Gene-Related Peptide) compound page, Migraine research.