Clinical trial NCT01471990: Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance
Official title: The Effect of PACAP38 and VIP on Migraine Patients Assessed by a 3-Tesla MR Scanner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Without Aura
Keywords: PACAP38
MMA
migraine
angiography
VIP
vasodilatation
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
name: University Hospital, Gentofte, Copenhagen
name: Lundbeck Foundation
name: Cool Sorption Foundation of 1988
First posted: 2011-11-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility 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

Primary outcomes:
measure: Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions
timeFrame: Baseline, 20 minutes, 2 hours and 5 hours
Secondary outcomes:
measure: Headache scores
timeFrame: 24 hours
measure: Comparison between PACAP38 and VIP induced changes in BOLD response
timeFrame: 5 hours
measure: Change in intracranial artery circumference before and after injection of sumatriptan
timeFrame: 5 hours
measure: Comparison between PACAP38 and VIP induced changes in brain structure
timeFrame: 5 hours
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen
Study officials:
affiliation: Danish Headache Centre and Department of Neurology, Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen
name: Faisal Amin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: