Ignite Creation Date:
2024-05-06 @ 2:16 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04260035
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2020-02-05
Brief Title:
The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide VIP in Episodic Migraine Patients
Sponsor:
Danish Headache Center
Organization:
Danish Headache Center
Study Overview
Official Title:
The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide VIP on Headache Cranial Hemodynamic and Autonomic Symptoms in Episodic Migraine Patients Without Aura
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Vasoactive intestinal peptide VIP is a peptide of 28 amino acid residues that belongs to the glucagonsecretin superfamily of peptides 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 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 it may induce migraine-like attacks in migraine patients as a twenty-minute infusion of PACAP is unknown
Detailed Description:
The vasoactive intestinal polypeptide VIP is a peptide of 28 amino acid residues that belongs to the glucagonsecretin superfamily of peptides It is distributed in different regions of the nervous system including several autonomic ganglia and the brain Once released from neurons it acts on the vasoactive intestinal peptide receptor 1 VPAC1 the vasoactive intestinal peptide receptor 2 VPAC2 and the pituitary adenylate cyclase-activating polypeptide type I receptor PAC1 All three belong to a family of G-protein coupled receptors sharing the activation of adenylate cyclase and the increase in intracellular cyclic adenosine monophosphate cAMP The three receptors are involved in many physiological functions among them the vasodilating and parasympathetic responses VPAC1 and VPAC2 are expressed in dura mater vessels and are primarily responsible for the relaxation of arteries PAC1 is located in the trigemino-autonomic system but not in blood vessels VIP shares the binding to the three aforementioned receptors with other peptides including the pituitary adenylate cyclase-activating polypeptide-38 PACAP38 and the pituitary adenylate cyclase-activating polypeptide-27 PACAP27
20-minute infusion of VIP and PACAPs in patients with migraine dilated cranial arteries However only PACAP27 and PACAP38 induced a sustained cranial vasodilation and migraine like-attacks VIP-induced cranial vasodilation was of short duration and patients did not report migraine-like attacks The discrepancy was ascribed to the preferential activation of the PAC1 receptor by PACAPs but a monoclonal antibody against PAC1 receptor recently failed in migraine prevention Currently it is unknown whether the prolonged cranial vasodilation related with the appearance of migraine-like attacks More recently a two-hour infusion of VIP promoted a long-lasting cranial vasodilation and delayed headache in healthy volunteers resembling the effect of PACAP27 and PACAP38 two closely related peptides causing migraine Whether a long-lasting infusion of VIP may induce a sustained cranial vasodilation and migraine-like attacks in migraine patients as a twenty-minute infusion of PACAP27 and PACAP38 is unknown
20-minute infusion of VIP and PACAPs in patients with migraine dilated cranial arteries However only PACAP27 and PACAP38 induced a sustained cranial vasodilation and migraine like-attacks VIP-induced cranial vasodilation was of short duration and patients did not report migraine-like attacks The discrepancy was ascribed to the preferential activation of the PAC1 receptor by PACAPs but a monoclonal antibody against PAC1 receptor recently failed in migraine prevention Currently it is unknown whether the prolonged cranial vasodilation related with the appearance of migraine-like attacks More recently a two-hour infusion of VIP promoted a long-lasting cranial vasodilation and delayed headache in healthy volunteers resembling the effect of PACAP27 and PACAP38 two closely related peptides causing migraine Whether a long-lasting infusion of VIP may induce a sustained cranial vasodilation and migraine-like attacks in migraine patients as a twenty-minute infusion of PACAP27 and PACAP38 is unknown
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None