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Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

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ClinicalTrials.gov Identifier: NCT00510172
Recruitment Status : Unknown
Verified July 2007 by Glostrup University Hospital, Copenhagen.
Recruitment status was:  Recruiting
First Posted : August 1, 2007
Last Update Posted : August 1, 2007
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen

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

Condition or disease Intervention/treatment
Headache Migraine Vasodilatation Drug: Prostacyclin, PGI2 Drug: Placebo

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Basic Science
Official Title: Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2
Study Start Date : December 2006
Estimated Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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%



Primary Outcome Measures :
  1. 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 :
  1. Blood pressure, pulse [ Time Frame: 100 min ]


Information from the National Library of Medicine

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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:

  • 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.

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): 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

ClinicalTrials.gov Identifier: NCT00510172     History of Changes
Other Study ID Numbers: KA-20060086
First Posted: August 1, 2007    Key Record Dates
Last Update Posted: August 1, 2007
Last Verified: July 2007

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

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
Epoprostenol
Tezosentan
Antihypertensive Agents
Platelet Aggregation Inhibitors
Vasodilator Agents