The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) in Episodic Migraine Patients

What Was Tested

This registered not phased trial tested VIP (Vasoactive Intestinal Peptide) for migraine.

Vasoactive intestinal peptide (VIP) is a peptide of 28 amino acid residues that belongs to the glucagon/secretin superfamily of peptides.

Along with other neuropeptides, such as calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase-activating polypeptide (PACAP), it is released from the trigeminal afferents and exerts a strong vasodilating activity on the cranial vasculature.

It had two arms (groups): Vasoactive Intestinal Polypeptide (VIP) (active comparator) and Sterile, isotonic, non-active saline (Placebo) (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The vasoactive intestinal polypeptide (VIP) is a peptide of 28 amino acid residues that belongs to the glucagon/secretin superfamily of peptides.

It is distributed in different regions of the nervous system, including several autonomic ganglia and the brain.

Once released from neurons, it acts on the vasoactive intestinal peptide receptor 1 (VPAC1), the vasoactive intestinal peptide receptor 2 (VPAC2) and the pituitary adenylate cyclase-activating polypeptide type I receptor (PAC1).

The three receptors are involved in many physiological functions, among them the vasodilating and parasympathetic responses.

Who Took Part

The registry lists 21 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: Diagnosis of migraine without aura as according to the International Classification. Frequency of migraine attacks between one and six attacks within 8 weeks. Weight: 50-90 kg.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: daily intake of any medicine other than oral contraception; pregnant or breastfeeding women; cardiovascular disease of all kinds, including cerebrovascular disease.

How the Study Was Run

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

The migraine participants were allocated by chance, so the VIP (Vasoactive Intestinal Peptide) group and the comparison group should start out alike.

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 2020-05-19 with completion listed for 2020-09-15.

It ran at 1 site in Denmark.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Occurrence of migraine-like attacks (time frame: Before (-10 minutes) and after the drug administration (+12 hours)).

It also tracked 4 secondary outcomes, for example Change in cranial hemodynamic, Change in Mean Arterial Pressure and Change in Heart Rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of VIP (Vasoactive Intestinal Peptide) in 21 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, Migraine research.