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Completed

NCT Number: NCT01471990

Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

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.

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Key information

Conditions

Migraine Without Aura Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen

Glostrup Municipality, DK-2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pituitary Adenylate Cyclase-Activating Polypeptide-38

Drug

10 pmol/kg/min over 20 mins

vasoactive intestinal peptide

Drug

8 pmol/kg/min over 20 mins

Primary outcomes

  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

  1. Headache scores

    Time frame: 24 hours

    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

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 16, 2011
Registry last updated
Aug 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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