Hypersensitivity to PACAP-38 in post-traumatic headache: a randomized clinical trial

What Was Tested

This randomized controlled trial paper looks at PACAP.

Pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), known for its role in migraine pathogenesis, has been identified as a novel drug target.

Given the clinical parallels between post-traumatic headache (PTH) and migraine, the researchers explored the possible role of PACAP-38 in the pathogenesis of PTH.

Who Took Part

The study group was 49 individuals.

PubMed indexes the participants as adults, both men and women.

Of 49 individuals assessed for eligibility, 21 were enrolled and completed the trial.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled, crossover and parallel-group study.

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

Neither the individuals nor the staff measuring them knew who was on PACAP, so expectations could not easily colour the readings.

Some individuals received a placebo instead of PACAP, giving a reference point.

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

What Was Measured

The primary outcome was the difference in incidence of migraine-like headache between PACAP-38 and placebo during a 12-h observational period post-infusion.

The secondary outcome was the difference in the area under the curve (AUC) for baseline-corrected median headache intensity scores during the same 12-h observational period.

PubMed files the paper under topics including Migraine Disorders, Pituitary Adenylate Cyclase-Activating Polypeptide and Post-Traumatic Headache.

The authors tagged it with the keywords concussion, headache disorders, pathophysiology and trigeminovascular system.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of PACAP in 49 individuals.

The publication is from 2024 (Brain : a journal of neurology), a journal based in England.

More context: the PACAP compound page, all human trials.