Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of PACAP38 and VIP on Migraine Patients Assessed by a 3-Tesla MR Scanner

Conditions
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Migraine Without Aura

Intervention / Treatment
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* Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38
* Drug: Vasoactive Intestinal Peptide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PACAP38<br> | Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38<br>* 10 pmol/kg/min over 20 mins<br>|
| Active Comparator: VIP<br> | Drug: Vasoactive Intestinal Peptide<br>* 8 pmol/kg/min over 20 mins<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache scores | hospital and post hospital phase | 24 hours | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PACAP38, MMA, migraine, angiography, VIP, vasodilatation