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Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by Glostrup University Hospital, Copenhagen.
Recruitment status was:  Recruiting
Information provided by:
Glostrup University Hospital, Copenhagen Identifier:
First received: July 30, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
We hypothesised that intravenous infusion of PGI2 induced headache or migraine and cranial vasodilatation in migraineurs.

Condition Intervention
Drug: Prostacyclin, PGI2
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Basic Science
Official Title: Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

Resource links provided by NLM:

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Headache and accompanying symptoms. Blood flow velocity in the middle cerebral artery, diameter changes in superficial temporal artery and radial artery. [ Time Frame: 14 hours ]

Secondary Outcome Measures:
  • Blood pressure, pulse [ Time Frame: 100 min ]

Estimated Enrollment: 12
Study Start Date: December 2006
Estimated Study Completion Date: September 2007
Arms Assigned Interventions
Active Comparator: 1
Active treatment
Drug: Prostacyclin, PGI2
10 ng/kg/min of epoprostenol (stable PGI2)
Placebo Comparator: 2
Drug: Placebo
NaCL 0,9%


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • migraine without aura and healthy apart from that
  • age 18-55 years
  • 50-100 kg
  • Secure contraceptives

Exclusion Criteria:

  • Tension Type Headache more than 3 time a month
  • Other primary headaches
  • Medication prior to the study (closer than 4 times plasma halflife)
  • Migraine or headache 5 days prior to study.
  • Hypertension (systolic BP >150 mmHg and/or diastolic BP >100 mmHg).
  • Hypotension (systolic BP <90 mmHg and/or diastolic BP <50 mmHg).
  • Heart-vessel disease of any kind incl cerebrovascular disease.
  • Anamnestic or clinical signs of psychiatric disease or abuse.
  • Anamnestic or clinical signs of disease of any kind relevant for participation in the study.
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Please refer to this study by its identifier: NCT00510172

Contact: Troels Wienecke, MD + 45 43 23 45 14

Danish Headache Center Recruiting
Copenhagen, Glostrup, Denmark, DK-2600
Principal Investigator: Troels Wienecke, MD         
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Principal Investigator: Troels Wienecke, MD Danish Headache Center
  More Information Identifier: NCT00510172     History of Changes
Other Study ID Numbers: KA-20060086
Study First Received: July 30, 2007
Last Updated: July 30, 2007

Keywords provided by Glostrup University Hospital, Copenhagen:

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Antihypertensive Agents
Platelet Aggregation Inhibitors
Vasodilator Agents processed this record on May 25, 2017