Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

This study is currently recruiting participants.

Verified by Glostrup University Hospital,Copenhagen, July 2007

First Received: 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:	Basic Science, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
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
1: Active Comparator Active treatment	Drug: Prostacyclin, PGI2 10 ng/kg/min of epoprostenol (stable PGI2)
2: Placebo Comparator 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, Glostrup
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

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

Keywords provided by Glostrup University Hospital,Copenhagen:

Headache
Migraine
Vasodilatation

Additional relevant MeSH terms:

Nervous System Diseases
Hematologic Agents
Central Nervous System Diseases
Pain
Headache Disorders, Primary
Cardiovascular Agents
Antihypertensive Agents
Brain Diseases
Pharmacologic Actions

Headache Disorders
Signs and Symptoms
Migraine Disorders
Therapeutic Uses
Headache
Epoprostenol
Neurologic Manifestations
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on November 09, 2009