The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) on Headache, Cranial Hemodynamic and Autonomic Symptoms in Healthy Volunteers
- Conditions
- Headache Disorders
- Interventions
- Drug: Vasoactive Intestinal Peptide (VIP) and Saline
- Registration Number
- NCT03989817
- Lead Sponsor
- Danish Headache Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
18-60 years. 50-90 kg. Women of childbearing potential must use adequate contraception.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Saline Vasoactive Intestinal Peptide (VIP) and Saline To investigate the role of saline on cranial hemodynamic and headache in healthy volunteers. VIP Vasoactive Intestinal Peptide (VIP) and Saline To investigate the role of VIP on cranial hemodynamic and headache in healthy volunteers.
- Primary Outcome Measures
Name Time Method Change in cranial hemodynamic Before (-10 minutes) and after infusion (+2 hours) of VIP compared with before and after infusion of saline] Change on diameter of superficial temporal artery. Change on diameter will be measured with milletimeter.
Occurrence and change of headache [Time Frame: Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline] Occurrence of headache measured by numerical rating scale (NRS)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Danish headache center
🇩🇰København S, Danmark, Denmark