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Trial record 29 of 245 for:    Recruiting, Not yet recruiting, Available Studies | Headache

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

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ClinicalTrials.gov Identifier: NCT03989817
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammad Al-Mahdi Al-Karagholi, 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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.




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)



Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989817


Contacts
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Contact: Mohammad A Al-Karagholi 31191647 mahdi.alkaragholi@gmail.com
Contact: Lanfranco Pellesi 00 39 340 9383056 lanfranco.pellesi@gmail.com

Locations
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Denmark
Danish headache center Recruiting
København S, Danmark, Denmark, 2300
Contact: Mohammad A Al-Karagholi    31191647    mahdi.alkaragholi@gmail.com   
Sponsors and Collaborators
Danish Headache Center

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Responsible Party: Mohammad Al-Mahdi Al-Karagholi, MD, PhD student, Principal investigator, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03989817     History of Changes
Other Study ID Numbers: VIP H-18050862
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Headache Disorders
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vasoactive Intestinal Peptide
Gastrointestinal Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs