The Effect of Sumatriptan and Placebo on CGRP Induced Headache

What Was Tested

The trial (not phased) is built around CGRP (Calcitonin Gene-Related Peptide) for migraine.

It had two arms (groups): Sumatriptan (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed.

Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.

Who Took Part

30 actual participants took part.

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

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

How the Study Was Run

It was run as a randomized, crossover and double-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.

Blinding on both sides kept the migraine participants and researchers unaware of who received CGRP (Calcitonin Gene-Related Peptide).

Those kept unaware of assignments: participant and investigator.

It started in 2018-02-15 with completion listed for 2018-09-01.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: AUC after infusion (time frame: 1 year).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of CGRP (Calcitonin Gene-Related Peptide) in 30 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 CGRP (Calcitonin Gene-Related Peptide) compound page, Migraine research.