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Trial · Interventional

CompletedNot applicableRegistry data

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

NCTNCT03989817 (opens ClinicalTrials.gov in a new tab)Other idVIP H-18050862
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
12 participants (actual)
Sponsor
Danish Headache Center · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
14 Jun 2019
Primary completion
30 Jun 2020
Completion
30 Jun 2020
First posted
18 Jun 2019
Last update posted
20 Aug 2020
Conditions
Headache Disorders

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. N/A

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

    NCT03989817

    14 Jun 2019 to 30 Jun 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Vasoactive Intestinal Peptide (VIP) and SalineDrug

Arms2

  • Active comparator

    VIP

    To investigate the role of VIP on cranial hemodynamic and headache in healthy volunteers.

  • Placebo comparator

    Saline

    To investigate the role of saline on cranial hemodynamic and headache in healthy volunteers.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in cranial hemodynamic

    Time frame · Before (-10 minutes) and after infusion (+2 hours) of VIP compared with before and after infusion of saline]

    Registry description

    Change on diameter of superficial temporal artery. Change on diameter will be measured with milletimeter.

  2. Occurrence and change of headache

    Time frame · [Time Frame: Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline]

    Registry description

    Occurrence of headache measured by numerical rating scale (NRS)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

6 results

Two-hour infusion of vasoactive intestinal polypeptide induces delayed headache and extracranial vasodilation in healthy volunteers.

Pellesi et al. 2020Cephalalgia : an international journal of headachecited by 42

PMID 32594760DOI 10.1177/0333102420937655PUB-32594760

Full text at the publisher6 results
Publisher pageSee results (6)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedPellesi L, Al-Karagholi MA, De Icco R, Chaudhry BA, Lopez CL, Snellman J, Hannibal J, Amin FM, Ashina M. Plasma Levels of CGRP During a 2-h Infusion of VIP in Healthy Volunteers and Patients With Migraine: An Exploratory Study. Front Neurol. 2022 Apr 1;13:871176. doi: 10.3389/fneur.2022.871176. eCollection 2022. PMID 35432170

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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