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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 20, 2011

Last Updated Date

November 8, 2011

Start Date ^ICMJE

September 2010

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT01384812 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prostaglandin E2 in Migraine Suffers Without Aura.

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Condition ^ICMJE

"Migraine-like" Headache

Intervention ^ICMJE

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

Study Arm (s)

Placebo Comparator: Isoton sodium chloride
Intervention: Drug: isoton sodium chloride
Active Comparator: Prostin E2 (dinoprostone)
Intervention: Drug: dinoprostone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01384812

Other Study ID Numbers ^ICMJE

DHC-PGE2-2011

Has Data Monitoring Committee

Yes

Responsible Party

Troels Wienecke, Danish Headache Center

Study Sponsor ^ICMJE

Troels Wienecke

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Troels Wienecke, MD,PhD

Danish Headache Center

Information Provided By

Danish Headache Center

Verification Date

November 2011

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

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