An interventional study of Vasoactive Intestinal Peptide (VIP) and Saline in Headache Disorders, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-20.
Sponsored by Danish Headache Center · Not applicable, Interventional, and Other
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.
162 studies on the registry are indexed under Headache Disorders; 40 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 103 interventional studies indexed under Headache Disorders.
Browse Headache Disorders studies →Danish Headache Center is the lead sponsor of 125 studies on the registry; 15 are open to participants now.
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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.
To investigate the role of VIP on cranial hemodynamic and headache in healthy volunteers.
Drug: Vasoactive Intestinal Peptide (VIP) and Saline
To investigate the role of saline on cranial hemodynamic and headache in healthy volunteers.
Drug: Vasoactive Intestinal Peptide (VIP) and Saline
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.
Change in cranial hemodynamic
Change on diameter of superficial temporal artery. Change on diameter will be measured with milletimeter.
Time frame: 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: [Time Frame: Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline]
Plan to share: No
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Danish Headache Center