PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine

What Was Tested

In this not phased trial, researchers set out to test PACAP for migraine.

It had two arms (groups): PACAP38 + Imigran (active comparator) and PACAP38 + Isotonic Saline (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

Pituitary adenylate cyclase-activating peptide-38 (PACAP38) plays a role in migraine pathophysiology.

Infusions of PACAP38 can trigger migraine-like attacks in some migraine patients and will induce flushing in all patients.

The study will be conducted with a double-blind, placebo-controlled crossover study design.

Who Took Part

37 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of migraine, according to IHS criteria. Weight between 50 - 100 kilograms. Women in fertile age must not be pregnant and must use adequate contraception.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: migraine more than 5 days per month in average over the past year; migraine \< 72 hours before each experimental day; daily / frequent use of any medication apart from contraceptive medication.

How the Study Was Run

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

Each person switched between PACAP 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 PACAP.

Those kept unaware of assignments: participant and investigator.

It started in 2018-07-17 with completion listed for 2019-12-07.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 4 secondary outcomes, for example Severity of flushing, Facial temperature and Superficial temporal artery diameter.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of PACAP in 37 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 PACAP compound page, Migraine research.