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
  Purpose

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


Condition Intervention
"Migraine-like" Headache
Drug: dinoprostone
Drug: isoton sodium chloride

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Danish Headache Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 12
Study Start Date: September 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Isoton sodium chloride Drug: isoton sodium chloride
intravenous injection for 25 min
Other Name: placebo
Active Comparator: Prostin E2 (dinoprostone) Drug: dinoprostone
intravenous injection 0.4 μgr/kg/min for 25 min
Other Name: Prostin E2

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384812

Locations
Denmark
Danish Headache Center
Glostrup, Denmark
Sponsors and Collaborators
Troels Wienecke
Investigators
Principal Investigator: Troels Wienecke, MD,PhD Danish Headache Center
  More Information

No publications provided

Responsible Party: Troels Wienecke, MD,PhD, Danish Headache Center
ClinicalTrials.gov Identifier: NCT01384812     History of Changes
Other Study ID Numbers: DHC-PGE2-2011
Study First Received: June 20, 2011
Last Updated: November 8, 2011
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014