Trial | NCT01471990  Report issue

Title

Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance
The Effect of PACAP38 and VIP on Migraine Patients Assessed by a 3-Tesla MR Scanner

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
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 Started
May 31
2011
Primary Completion
Jun 30
2012
Study Completion
Jun 30
2012
Last Update
Aug 29
2012
Estimate

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

PACAP38 Active Comparator

VIP Active Comparator

Criteria 

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
No Results Posted