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

D

Danish Headache Center

Status

Completed

Conditions

Headache Disorders

Treatments

Drug: Vasoactive Intestinal Peptide (VIP) and Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT03989817
VIP H-18050862

Details and patient eligibility

About

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. 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, sharing the activation of adenylate cyclase. Especially, it shares 70% structure with PACAP and acts on the same receptors. But, unlike it, VIP cannot induce a long-lasting vasodilation and has a modest capability to induce migraine attacks. Whether a long-lasting infusion of VIP may induce a prolonged vasodilation in the cerebral vessels and migraine, as a twenty-minute infusion of PACAP, is unknown.

Enrollment

12 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18-60 years. 50-90 kg. Women of childbearing potential must use adequate contraception.

Exclusion criteria

Headache less than 48 hours before the tests start All primary headaches Daily consumption of drugs of any kind other than oral contraceptives Pregnant or nursing women. A cardiovascular disease of any kind, including cerebrovascular diseases.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

12 participants in 2 patient groups, including a placebo group

VIP
Active Comparator group
Description:
To investigate the role of VIP on cranial hemodynamic and headache in healthy volunteers.
Treatment:
Drug: Vasoactive Intestinal Peptide (VIP) and Saline
Saline
Placebo Comparator group
Description:
To investigate the role of saline on cranial hemodynamic and headache in healthy volunteers.
Treatment:
Drug: Vasoactive Intestinal Peptide (VIP) and Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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