Prostaglandin E2 in Migraine Suffers Without Aura.
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|ClinicalTrials.gov Identifier: NCT01384812|
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : November 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|"Migraine-like" Headache||Drug: dinoprostone Drug: isoton sodium chloride||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin E2 in Migraine Suffers Without Aura.|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
|Placebo Comparator: Isoton sodium chloride||
Drug: isoton sodium chloride
intravenous injection for 25 min
Other Name: placebo
|Active Comparator: Prostin E2 (dinoprostone)||
intravenous injection 0.4 μgr/kg/min for 25 min
Other Name: Prostin E2
- Headache score on a 10-point verbal rating scale (VRS). [ Time Frame: 24 h ]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.
- Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz). [ Time Frame: 90 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.
- Diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan. [ Time Frame: 90 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.
- Mean arterial blood pressure (MAP). [ Time Frame: 90 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.
- Electrocardiography (ECG). [ Time Frame: 90 min ]
- Heart rate (HR). [ Time Frame: 90 min ]
- End-tidal partial pressure of pCO2 (PetCO2). [ Time Frame: 90 min ]
- Transcutaneous arterial oxygen saturation (SAT) [ Time Frame: 90 min ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384812
|Danish Headache Center|
|Principal Investigator:||Troels Wienecke, MD,PhD||Danish Headache Center|