Prostaglandin E2 in Migraine Suffers Without Aura.

November 8, 2011 updated by: Troels Wienecke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark
        • Danish Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Isoton sodium chloride
Drug: isoton sodium chloride
intravenous injection for 25 min
Other Names:
  • placebo
Active Comparator: Prostin E2 (dinoprostone)
Drug: dinoprostone
intravenous injection 0.4 μgr/kg/min for 25 min
Other Names:
  • Prostin E2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 min
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.
90 min
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.
90 min
Electrocardiography (ECG).
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.
90 min
Heart rate (HR).
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.
90 min
End-tidal partial pressure of pCO2 (PetCO2).
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.
90 min
Transcutaneous arterial oxygen saturation (SAT)
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.
90 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Troels Wienecke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

June 20, 2011

First Submitted That Met QC Criteria

June 28, 2011

First Posted (Estimate)

June 29, 2011

Study Record Updates

Last Update Posted (Estimate)

November 9, 2011

Last Update Submitted That Met QC Criteria

November 8, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHC-PGE2-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on "Migraine-like" Headache

Clinical Trials on isoton sodium chloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe