Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance
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|ClinicalTrials.gov Identifier: NCT01471990|
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : August 29, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Migraine Without Aura||Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38 Drug: Vasoactive Intestinal Peptide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|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|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
|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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|