Prostaglandin E2 in Migraine Suffers Without Aura.

Study Overview
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Brief Summary
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The hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation of brain vessels in migraine patients without aura.

Official Title
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Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin E2 in Migraine Suffers Without Aura.

Conditions
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Migraine-like Headache

Intervention / Treatment
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* Drug: dinoprostone
* Drug: isoton sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with migraine without aura Exclusion Criteria: Tension type headache more than x 3 per month Other forms for primary headache Headache 24 h before the day of the investigation Migraine 48 h before the day of the investigation Hypertension Hypotension Pregnant/nursing Daily intake of medication (except oral contraceptives and migraine rescue medicine during migraine attack) Cardiovascular or central nervous system (CNS) disease Drug/alcohol abuse Psychiatric disease Asthma or any other lung diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Placebo Comparator: Isoton sodium chloride<br> | Drug: isoton sodium chloride<br>* intravenous injection for 25 min<br>* Other names: placebo;|
| Active Comparator: Prostin E2 (dinoprostone)<br> | Drug: dinoprostone<br>* intravenous injection 0.4 μgr/kg/min for 25 min<br>* Other names: Prostin E2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache score on a 10-point verbal rating scale (VRS). | Incidence of headache 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache. | 24 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz). | Changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0. | 90 min | 
| Diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan. | Changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0. | 90 min | 
| Mean arterial blood pressure (MAP). | Changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0. | 90 min | 
| Electrocardiography (ECG). | Changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0. | 90 min | 
| Heart rate (HR). | Changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0. | 90 min | 
| End-tidal partial pressure of pCO2 (PetCO2). | Changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0. | 90 min | 
| Transcutaneous arterial oxygen saturation (SAT) | Changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0. | 90 min |