Prostaglandin E2 in Migraine Suffers Without Aura.
|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 ]
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|