Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

Overview

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.

Full Title of Study: “The Effect of PACAP38 and VIP on Migraine Patients Assessed by a 3-Tesla MR Scanner”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2012

Interventions

  • Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38
    • 10 pmol/kg/min over 20 mins
  • Drug: Vasoactive Intestinal Peptide
    • 8 pmol/kg/min over 20 mins

Arms, Groups and Cohorts

  • Active Comparator: PACAP38
  • Active Comparator: VIP

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 40 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Glostrup University Hospital, Copenhagen
    • Collaborator
      • Bispebjerg Hospital
    • Provider of Information About this Clinical Study
      • Principal Investigator: Faisal Mohammad Amin, medical doctor – Glostrup University Hospital, Copenhagen
    • Overall Official(s)
      • Faisal Amin, M.D., Principal Investigator, Danish Headache Centre and Department of Neurology, Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen

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