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.
|Migraine Without Aura||Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38 Drug: Vasoactive Intestinal Peptide|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
|Official Title:||The Effect of PACAP38 and VIP on Migraine Patients Assessed by a 3-Tesla MR Scanner|
- 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 ]
- 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 ]
|Study Start Date:||May 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: PACAP38||
Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38
10 pmol/kg/min over 20 mins
|Active Comparator: VIP||
Drug: Vasoactive Intestinal Peptide
8 pmol/kg/min over 20 mins
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471990
|Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen|
|Glostrup, Denmark, DK-2600|
|Principal Investigator:||Faisal Amin, M.D.||Danish Headache Centre and Department of Neurology, Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen|