The effect of Lu AG09222 on PACAP38- and VIP-induced vasodilation, heart rate increase, and headache in healthy subjects: an interventional, randomized, double-blind, parallel-group, placebo-controlled study

What Was Tested

This randomized controlled trial paper looks at PACAP.

Their objective was to determine whether Lu AG09222-an investigational humanized monoclonal antibody directed against PACAP ligand-would inhibit the PACAP-signaling cascade by abolishing its vasodilatory and headache-inducing abilities.

Why It Was Studied

Pituitary adenylate cyclase-activating polypeptide (PACAP), structurally related to vasoactive intestinal peptide (VIP), is one of the important mediators in the pathogenesis of migraine and is known to dilate cranial arteries and induce headache and migraine.

Registration date: July 19, 2021.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and parallel-group study.

Because people in this PACAP study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind PACAP study, the assignments were hidden from both participants and investigators until the end.

A placebo (an inactive look-alike) gave the PACAP group a baseline to be compared against.

Groups ran in parallel: each of the participants stayed in one arm throughout.

The primary outcome measure was area under the curve (AUC) of the change in superficial temporal artery (STA) diameter from 0 to 120 min after start of infusion of PACAP38.

The study was conducted at the Danish Headache Center in Copenhagen, Denmark.

What Was Measured

Pituitary adenylate cyclase-activating polypeptide (PACAP), structurally related to vasoactive intestinal peptide (VIP), is one of the important mediators in the pathogenesis of migraine and is known to dilate cranial arteries and induce headache and migraine.

PubMed files the paper under topics including Headache, Healthy Volunteers, Heart Rate, Migraine Disorders, Pituitary Adenylate Cyclase-Activating Polypeptide, Vasoactive Intestinal Peptide and Vasodilation.

The authors tagged it with the keywords Migraine treatment and Monoclonal antibody.

What This Means in Plain Language

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

Results are reported in around 4 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2023 (The journal of headache and pain), a journal based in England.

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