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

First Received on July 30, 2007. No Changes Posted

Sponsor:	Glostrup University Hospital, Copenhagen
Information provided by:	Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:	NCT00510172

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:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Epoprostenol Epoprostenol sodium

U.S. FDA Resources

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
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012