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出境医 / 临床实验 / The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) on Headache, Cranial Hemodynamic and Autonomic Symptoms in Healthy Volunteers

The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) on Headache, Cranial Hemodynamic and Autonomic Symptoms in Healthy Volunteers

Study Description
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.

Condition or disease Intervention/treatment Phase
Headache Disorders Drug: Vasoactive Intestinal Peptide (VIP) and Saline Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) on Headache, Cranial Hemodynamic in Healthy Volunteers
Actual Study Start Date : June 14, 2019
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: VIP
To investigate the role of VIP 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.
Placebo Comparator: 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.
Outcome Measures
Primary Outcome Measures :
  1. Change in cranial hemodynamic [ Time Frame: 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.

  2. 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] ]
    Occurrence of headache measured by numerical rating scale (NRS)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations

Locations
Layout table for location information
Denmark
Danish headache center
København S, Danmark, Denmark, 2300
Sponsors and Collaborators
Danish Headache Center
Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE June 14, 2019
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Change in cranial hemodynamic [ Time Frame: 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: [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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) on Headache, Cranial Hemodynamic and Autonomic Symptoms in Healthy Volunteers
Official Title  ICMJE The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) on Headache, Cranial Hemodynamic in Healthy Volunteers
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Headache Disorders
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: VIP
    To investigate the role of VIP on cranial hemodynamic and headache in healthy volunteers.
    Intervention: Drug: Vasoactive Intestinal Peptide (VIP) and Saline
  • Placebo Comparator: Saline
    To investigate the role of saline on cranial hemodynamic and headache in healthy volunteers.
    Intervention: Drug: Vasoactive Intestinal Peptide (VIP) and Saline
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2019) 		12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03989817
Other Study ID Numbers  ICMJE VIP H-18050862
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center
Study Sponsor  ICMJE Danish Headache Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Danish Headache Center
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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