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Prostaglandin E2 in Migraine Suffers Without Aura.

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ClinicalTrials.gov Identifier: NCT01384812
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : November 9, 2011
Sponsor:
Information provided by (Responsible Party):
Troels Wienecke, Danish Headache Center

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

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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384812


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

Responsible Party: Troels Wienecke, MD,PhD, Danish Headache Center
ClinicalTrials.gov Identifier: NCT01384812     History of Changes
Other Study ID Numbers: DHC-PGE2-2011
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: November 9, 2011
Last Verified: November 2011

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