Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

What Was Tested

In this not phased trial, researchers set out to test VIP (Vasoactive Intestinal Peptide) and PACAP for migraine.

The purpose of this study is to examine and compare the effect of pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide (VIP) on intracranial arteries and neuronal activity in patients with migraine without aura using a high resolution magnetic resonance imaging (MRI), including MR angiography (MRA) and functional MRI (fMRI).

MRA will be used to detect changes in intracranial artery circumferences before and after PACAP38 and VIP. fMRI will be used oo detect changes in blood-oxygenation-level-dependent-signal (BOLD-signal).

PACAP38 but not VIP induces migraine like attacks in migraine patients.

It had two arms (groups): PACAP38 (active comparator) and VIP (active comparator).

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

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

Examples of who could join: Healthy migraine patient without aura. Weight 50-100 kg.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: tension type headache more than 5 days per month; other primary headaches; daily use of medication except contraceptives.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Because people in this VIP (Vasoactive Intestinal Peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the migraine participants took both VIP (Vasoactive Intestinal Peptide) and the comparison in turn, acting as their own control.

Neither the migraine participants nor the staff measuring them knew who was on VIP (Vasoactive Intestinal Peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-05 with completion listed for 2012-06.

It ran at 1 site in Denmark.

What Was Measured

Primary outcome: Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions (time frame: Baseline, 20 minutes, 2 hours and 5 hours).

It also tracked 4 secondary outcomes, for example Headache scores, Comparison between PACAP38 and VIP induced changes in BOLD response, Change in intracranial artery circumference before and after injection of sumatriptan and Comparison between PACAP38 and VIP induced changes in brain structure.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of VIP (Vasoactive Intestinal Peptide) and PACAP in 24 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 VIP (Vasoactive Intestinal Peptide) compound page and the PACAP compound page, Migraine research.