The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) on Headache, Cranial Hemodynamic and Autonomic Symptoms in Healthy Volunteers

What Was Tested

The trial (not phased) is built around VIP (Vasoactive Intestinal Peptide).

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

It is produced in different regions of the nervous system, including the brain, trigeminovascular system and several autonomic nerves.

Once released from neurons, it acts on vasoactive intestinal peptide receptor 1 (VPAC1), vasoactive intestinal peptide receptor 2 (VPAC2) and pituitary adenylate cyclase-activating polypeptide type I receptor (PAC1), by mediating smooth muscle relaxation, vasodilation and water secretion.

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

The registry classes the interventions as drug.

Who Took Part

12 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

How the Study Was Run

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

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 participants took both VIP (Vasoactive Intestinal Peptide) and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received VIP (Vasoactive Intestinal Peptide).

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

It started in 2019-06-14 with completion listed for 2020-06-30.

It ran at 1 site in Denmark.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Change in cranial hemodynamic (time frame: Before (-10 minutes) and after infusion (+2 hours) of VIP compared with before and after infusion of saline]).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of VIP (Vasoactive Intestinal Peptide) in 12 people.

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, all human trials.