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Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

G

Glostrup University Hospital, Copenhagen

Status

Completed

Conditions

Migraine Without Aura

Treatments

Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38
Drug: Vasoactive Intestinal Peptide

Study type

Interventional

Funder types

Other

Identifiers

NCT01471990
H-1-2011-023

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

PACAP38
Active Comparator group
Treatment:
Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38
VIP
Active Comparator group
Treatment:
Drug: Vasoactive Intestinal Peptide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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