CGRP-induced Migraine Attacks in Patients Who Have Tried Anti-CGRP Monoclonal Antibody Treatment

What Was Tested

This registered not phased trial tested CGRP (Calcitonin Gene-Related Peptide) for migraine.

It had two arms (groups): Calcitonin gene-related peptide (experimental) and Placebo (experimental).

Infusion with placebo (isotonic saline).

The registry classes the interventions as drug and other.

More on the Plan

Calcitonin gene-related peptide (CGRP) plays a role in migraine pathophysiology.

The underlying mechanisms of these effects are largely unknown.

The investigators will use a double-blind, placebo-controlled crossover study design to examine migraine susceptibility to CGRP in these patients.

Who Took Part

Enrollment: 40 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: Subject has tried anti-CGRP antibodies for migraine.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: ingestion of any drug 4 half-lifes before study start apart from contraceptives; pregnant or breast-feeding women; migraine on the study day or less than 48 hours before cgrp infusion.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got CGRP (Calcitonin Gene-Related Peptide) and who got the comparison, which limits bias.

Each person switched between CGRP (Calcitonin Gene-Related Peptide) 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 CGRP (Calcitonin Gene-Related Peptide).

Those kept unaware of assignments: participant and investigator.

It started in 2016-07 with completion listed for 2019-09.

It ran at 1 site in Denmark.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Incidence of migraine (time frame: From 0 to 12 hours after CGRP infusion).

It also tracked 2 secondary outcomes, for example Heart rate and Blood pressure.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of CGRP (Calcitonin Gene-Related Peptide) in 40 people with migraine.

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.