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Trial · Interventional

CompletedNot applicableRegistry data

The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) in Episodic Migraine Patients

NCTNCT04260035 (opens ClinicalTrials.gov in a new tab)Other idH-19075630
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
21 participants (actual)
Sponsor
Danish Headache Center · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
19 May 2020
Primary completion
15 Sept 2020
Completion
15 Sept 2020
First posted
7 Feb 2020
Last update posted
20 Oct 2020
Conditions
Migraine · Pain · Neurologic Manifestations · Signs and Symptoms · Brain Diseases · Central Nervous System Diseases

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20202021
  1. N/A

    The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) in Episodic Migraine Patients

    NCT04260035

    19 May 2020 to 15 Sept 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Vasoactive intestinal peptide (VIP) is a peptide of 28 amino acid residues that belongs to the glucagon/secretin 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.

Interventions

  • Vasoactive Intestinal Polypeptide (VIP)Drug
  • Sterile salineDrug

Arms2

  • Active comparator

    Vasoactive Intestinal Polypeptide (VIP)

    Intravenous infusion of 8 pmol/Kg/min of Vasoactive Intestinal Polypeptide (VIP). The infusion is administered at constant speed by an automatic pump, lasting 120 minutes.

  • Placebo comparator

    Sterile, isotonic, non-active saline (Placebo)

    Intravenous infusion of sterile, isotonic, non-active saline 9 mg/ml (placebo). The infusion is administered at constant speed by an automatic pump, lasting 120 minutes.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Occurrence of migraine-like attacks

    Time frame · Before (-10 minutes) and after the drug administration (+12 hours)

    Registry description

    Migraine-like attack fulfilling either (i) or (ii): (i) Headache fulfilling criteria C and D for migraine without aura according to the International Classification od Headache Disorders: C. Headache has at least two of the following four characteristics: unilateral location; pulsating quality; moderate or severe pain intensity (moderate pain intensity is considered 5 or 4 on verbal rating scale); aggravation by cough (hospitalization phase) or causing avoidance of routine physical activity (out-hospital phase); D. During headache at least one of the following: nausea and/or vomiting; photophobia and phonophobia; (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication).

Secondary outcomes(4)

  1. Change in cranial hemodynamic

    Time frame · Before (-10 minutes) and after the drug administration (+3 hours)

    Registry description

    Change on diameter (mm) of superficial temporal artery (STA)

  2. Occurrence of headache and change of headache intensity scores

    Time frame · Before (-10 minutes) and after the drug administration (+12 hours)

    Registry description

    Headache intensity scores are measured by a numerical rating scale (NRS). It is a verbally declared scale from 0 to 10, where 0 is no headache; 1 is a very mild headache, including a feeling of pressing or throbbing; 5 is a moderate headache; 10 is the worst imaginable headache.

  3. Change in Mean Arterial Pressure

    Time frame · Before (-10 minutes) and after the drug administration (+3 hours and 20 minutes)

    Registry description

    Blood pressure was measured using an auto-inflatable cuff (Protocol, Oregon, USA). Blood pressure was registered as mean arterial pressure (MAP), equal to diastolic blood pressure + 1/3 (systolic blood pressure - diastolic blood pressure).

  4. Change in Heart Rate

    Time frame · Before (-10 minutes) and after the drug administration (+3 hours and 20 minutes)

    Registry description

    Heart rate was measured using an auto-inflatable cuff (Protocol, Oregon, USA).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

4 results

Effect of Vasoactive Intestinal Polypeptide on Development of Migraine Headaches: A Randomized Clinical Trial.

Pellesi et al. 2021JAMA network opencited by 65

PMID 34357396PMC8346940DOI 10.1001/jamanetworkopen.2021.18543PUB-34357396

CC BY4 results
Download PDFSee results (4)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedPellesi 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. PMID 35432170

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosis of migraine without aura as according to the International Classification * Frequency of migraine attacks between one and six attacks within 8 weeks * Weight: 50-90 kg * Fertile women should use contraception. Fertile women do not include hysterectomies women or women who are postmenopausal for at least 2 years. Contraception includes either IUD, birth control pills, surgical sterilization of the woman or depot progesterone Exclusion Criteria: * Any other type of headache (including \> 2 days of tension-type headache per month) * Headache less than 48 hours before the start of the experiment * Daily intake of any medicine other than oral contraception * Pregnant or breastfeeding women * Clinical signs of Hypertension (systolic blood pressure \> 150 mmHg and / or diastolic blood pressure \> 100 mmHg) and/or Hypotension (systolic blood pressure \< 90 mm Hg and / or diastolic blood pressure \< 50 mmHg) * Cardiovascular disease of all kinds, including cerebrovascular disease * Anamnestic or clinical signs of mental illness, abuse or smoking

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