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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isoton sodium chloride | Placebo Comparator |
| |
| Prostin E2 (dinoprostone) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dinoprostone | Drug | intravenous injection 0.4 μgr/kg/min for 25 min |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Troels Wienecke, MD,PhD | Danish Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Glostrup Municipality | Denmark |
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| ID | Term |
|---|---|
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| isoton sodium chloride | Drug | intravenous injection for 25 min |
|
|
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 |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |