The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) on Headache, Cranial Hemodynamic and Autonomic Symptoms in Healthy Volunteers
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2019
CompletedStudy Start
First participant enrolled
June 14, 2019
CompletedFirst Posted
Study publicly available on registry
June 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedAugust 20, 2020
August 1, 2020
1 year
June 14, 2019
August 19, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Change in cranial hemodynamic
Change on diameter of superficial temporal artery. Change on diameter will be measured with milletimeter.
Before (-10 minutes) and after infusion (+2 hours) of VIP compared with before and after infusion of saline]
Occurrence and change of headache
Occurrence of headache measured by numerical rating scale (NRS)
[Time Frame: Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline]
Study Arms (2)
VIP
ACTIVE COMPARATORTo investigate the role of VIP on cranial hemodynamic and headache in healthy volunteers.
Saline
PLACEBO COMPARATORTo investigate the role of saline on cranial hemodynamic and headache in healthy volunteers.
Interventions
12 healthy volunteers of both genders will be included in the main study. Participants will meet twice, with at least one week in between. The main study is a double-blind, randomized, cross-over trial among placebo (sterile saline, non-active substance) and VIP. Intravenous infusion of VIP / placebo (saline) will be conducted over 120 minutes. Patients will be asked after each trial day to record headache strength, accompanying symptoms, and drug use for up to 24 post-infusion.
Eligibility Criteria
You may qualify if:
- years. 50-90 kg. Women of childbearing potential must use adequate contraception.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Danish headache center
København S, Danmark, 2300, Denmark
Related Publications (2)
Pellesi 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: 35432170DERIVEDPellesi L, Al-Karagholi MA, Chaudhry BA, Lopez CL, Snellman J, Hannibal J, Amin FM, Ashina M. Two-hour infusion of vasoactive intestinal polypeptide induces delayed headache and extracranial vasodilation in healthy volunteers. Cephalalgia. 2020 Oct;40(11):1212-1223. doi: 10.1177/0333102420937655. Epub 2020 Jun 27.
PMID: 32594760DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD student, Principal investigator
Study Record Dates
First Submitted
June 14, 2019
First Posted
June 18, 2019
Study Start
June 14, 2019
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
August 20, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share