Migraine Without Aura
Conditions
Keywords
PACAP38, MMA, migraine, angiography, VIP, vasodilatation
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.
Interventions
DRUGPituitary Adenylate Cyclase-Activating Polypeptide-38
10 pmol/kg/min over 20 mins
8 pmol/kg/min over 20 mins
Sponsors
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Lundbeck Foundation
Cool Sorption Foundation of 1988
Glostrup University Hospital, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions | Baseline, 20 minutes, 2 hours and 5 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache scores | 24 hours | hospital and post hospital phase |
| Comparison between PACAP38 and VIP induced changes in BOLD response | 5 hours | — |
| Change in intracranial artery circumference before and after injection of sumatriptan | 5 hours | — |
| Comparison between PACAP38 and VIP induced changes in brain structure | 5 hours | — |
Countries
Denmark
Outcome results
None listed