Skip to content

Trial · Interventional

CompletedNot applicableRegistry data

Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

NCTNCT01471990 (opens ClinicalTrials.gov in a new tab)Other idH-1-2011-023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
24 participants (actual)
Sponsor
Glostrup University Hospital, Copenhagen · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
May 2011
Primary completion
Jun 2012
Completion
Jun 2012
First posted
16 Nov 2011 (estimated)
Last update posted
29 Aug 2012 (estimated)
Conditions
Migraine Without Aura

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013
  1. N/A

    Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

    NCT01471990

    May 2011 to Jun 2012

Registry summary

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

The purpose of this study is to examine and compare the effect of pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide (VIP) on intracranial arteries and neuronal activity in patients with migraine without aura using a high resolution magnetic resonance imaging (MRI), including MR angiography (MRA) and functional MRI (fMRI). MRA will be used to detect changes in intracranial artery circumferences before and after PACAP38 and VIP. fMRI will be used oo detect changes in blood-oxygenation-level-dependent-signal (BOLD-signal). PACAP38 but not VIP induces migraine like attacks in migraine patients. The migraine specific drug sumatriptan will be given to relieve pain and the effect will also be registered using MRA and fMRI.

Interventions

  • Pituitary Adenylate Cyclase-Activating Polypeptide-38Drug
  • Vasoactive Intestinal PeptideDrug

Arms2

  • Active comparator

    PACAP38

  • Active comparator

    VIP

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions

    Time frame · Baseline, 20 minutes, 2 hours and 5 hours

Secondary outcomes(4)

  1. Headache scores

    Time frame · 24 hours

    Registry description

    hospital and post hospital phase

  2. Comparison between PACAP38 and VIP induced changes in BOLD response

    Time frame · 5 hours

  3. Change in intracranial artery circumference before and after injection of sumatriptan

    Time frame · 5 hours

  4. Comparison between PACAP38 and VIP induced changes in brain structure

    Time frame · 5 hours

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

Studies0

Studies that cite this trial.

No study cites this trial.

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: * Healthy migraine patient without aura * Age 18-40 * Weight 50-100 kg * Fertile women must use safe contraceptives Exclusion Criteria: * Tension type headache more than 5 days per month * Other primary headaches * Daily use of medication except contraceptives * Drug taken within 4 times the half life for the specific drug except contraceptives * Pregnant or lactating women * Exposure to radiation within the last year * Hypotension or hypertension * Cardiovascular or cerebrovascular disease * Mental illness or substance abuse * Other significant conditions determined by the examining doctor * Contraindications to MRI scan * Headache within the last 48 hours before start of trial

PepBank is a research reference. Talk to a doctor before you use any peptide.