Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

August 28, 2012 updated by: Faisal Mohammad Amin, Glostrup University Hospital, Copenhagen

The Effect of PACAP38 and VIP on Migraine Patients Assessed by a 3-Tesla MR Scanner

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

  • Denmark
      • Glostrup, Denmark, DK-2600
        • Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen

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 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: PACAP38
Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38
10 pmol/kg/min over 20 mins
ACTIVE_COMPARATOR: VIP
Drug: Vasoactive Intestinal Peptide
8 pmol/kg/min over 20 mins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 20 minutes, 2 hours and 5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache scores
Time Frame: 24 hours
hospital and post hospital phase
24 hours
Comparison between PACAP38 and VIP induced changes in BOLD response
Time Frame: 5 hours
5 hours
Change in intracranial artery circumference before and after injection of sumatriptan
Time Frame: 5 hours
5 hours
Comparison between PACAP38 and VIP induced changes in brain structure
Time Frame: 5 hours
5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Collaborators

Bispebjerg Hospital
Lundbeck Foundation
University Hospital, Gentofte, Copenhagen
Cool Sorption Foundation of 1988

Investigators

  • Principal Investigator: Faisal Amin, M.D., Danish Headache Centre and Department of Neurology, Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen

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

May 1, 2011

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 10, 2011

First Posted (ESTIMATE)

November 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 29, 2012

Last Update Submitted That Met QC Criteria

August 28, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2011-023

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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