Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00510172
First received: July 30, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

We hypothesised that intravenous infusion of PGI2 induced headache or migraine and cranial vasodilatation in migraineurs.


Condition Intervention
Headache
Migraine
Vasodilatation
Drug: Prostacyclin, PGI2
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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
Placebo
Drug: Placebo
NaCL 0,9%

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510172

Contacts
Contact: Troels Wienecke, MD + 45 43 23 45 14 trowie01@glo.regionh.dk

Locations
Denmark
Danish Headache Center Recruiting
Copenhagen, Glostrup, Denmark, DK-2600
Principal Investigator: Troels Wienecke, MD         
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Troels Wienecke, MD Danish Headache Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00510172     History of Changes
Other Study ID Numbers: KA-20060086
Study First Received: July 30, 2007
Last Updated: July 30, 2007
Health Authority: Denmark: Ethics Committee

Keywords provided by Glostrup University Hospital, Copenhagen:
Headache
Migraine
Vasodilatation

Additional relevant MeSH terms:
Headache
Flushing
Hyperemia
Hot Flashes
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Epoprostenol
Tezosentan
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on April 20, 2014