- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03989817
The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) on Headache, Cranial Hemodynamic and Autonomic Symptoms in Healthy Volunteers
August 19, 2020 updated by: Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center
The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) on Headache, Cranial Hemodynamic in Healthy Volunteers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Danmark
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København S, Danmark, Denmark, 2300
- Danish Headache Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: VIP
To investigate the role of VIP on cranial hemodynamic and headache in healthy volunteers.
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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.
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Placebo Comparator: Saline
To investigate the role of saline on cranial hemodynamic and headache in healthy volunteers.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cranial hemodynamic
Time Frame: Before (-10 minutes) and after infusion (+2 hours) of VIP compared with before and after infusion of saline]
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Change on diameter of superficial temporal artery.
Change on diameter will be measured with milletimeter.
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Before (-10 minutes) and after infusion (+2 hours) of VIP compared with before and after infusion of saline]
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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]
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Occurrence of headache measured by numerical rating scale (NRS)
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[Time Frame: Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline]
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Pellesi 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2019
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
June 14, 2019
First Submitted That Met QC Criteria
June 17, 2019
First Posted (Actual)
June 18, 2019
Study Record Updates
Last Update Posted (Actual)
August 20, 2020
Last Update Submitted That Met QC Criteria
August 19, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VIP H-18050862
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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