Clinical Trial: Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effect of PACAP38 and VIP on Migraine Patients Assessed by a 3-Tesla MR Scanner
Brief Summary:
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.
Detailed Summary:
Sponsor: Glostrup University Hospital, Copenhagen
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Glostrup University Hospital, Copenhagen
Dates:
Date Received: November 9, 2011
Date Started: May 2011
Date Completion:
Last Updated: August 28, 2012
Last Verified: August 2012
