Prostaglandin E2 in Migraine Suffers Without Aura.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Troels Wienecke, Danish Headache Center
ClinicalTrials.gov Identifier:
NCT01384812
First received: June 20, 2011
Last updated: November 8, 2011
Last verified: November 2011

June 20, 2011
November 8, 2011
September 2010
July 2011   (final data collection date for primary outcome measure)
Headache score on a 10-point verbal rating scale (VRS). [ Time Frame: 24 h ] [ Designated as safety issue: No ]
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.
Headache score on a 10-point verbal rating scale (VRS) [ Time Frame: 24 h ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01384812 on ClinicalTrials.gov Archive Site
  • Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz). [ Time Frame: 90 min ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.
  • Heart rate (HR). [ Time Frame: 90 min ] [ Designated as safety issue: Yes ]
    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.
  • End-tidal partial pressure of pCO2 (PetCO2). [ Time Frame: 90 min ] [ Designated as safety issue: No ]
    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.
  • Transcutaneous arterial oxygen saturation (SAT) [ Time Frame: 90 min ] [ Designated as safety issue: Yes ]
    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.
  • Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz) [ Time Frame: 90 min ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.
  • heart rate (HR) [ Time Frame: 90 min ] [ Designated as safety issue: Yes ]
    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.
  • end-tidal partial pressure of pCO2 (PetCO2), [ Time Frame: 90 min ] [ Designated as safety issue: No ]
    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.
  • transcutaneous arterial oxygen saturation (SAT) [ Time Frame: 90 min ] [ Designated as safety issue: Yes ]
    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.
Not Provided
Not Provided
 
Prostaglandin E2 in Migraine Suffers Without Aura.
Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin E2 in Migraine Suffers Without Aura.

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
"Migraine-like" Headache
  • Drug: dinoprostone
    intravenous injection 0.4 μgr/kg/min for 25 min
    Other Name: Prostin E2
  • Drug: isoton sodium chloride
    intravenous injection for 25 min
    Other Name: placebo
  • Placebo Comparator: Isoton sodium chloride
    Intervention: Drug: isoton sodium chloride
  • Active Comparator: Prostin E2 (dinoprostone)
    Intervention: Drug: dinoprostone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01384812
DHC-PGE2-2011
Yes
Troels Wienecke, Danish Headache Center
Troels Wienecke
Not Provided
Principal Investigator: Troels Wienecke, MD,PhD Danish Headache Center
Danish Headache Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP