Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2 - Full Text View

Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

This study is currently recruiting participants.
Verified by Glostrup University Hospital,Copenhagen, July 2007

Sponsored by:	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

Genetics Home Reference related topics:

familial hemiplegic migraine

MedlinePlus related topics:

Headache Migraine

ChemIDplus related topics:

Epoprostenol Epoprostenol sodium

U.S. FDA Resources

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

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

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

Keywords provided by Glostrup University Hospital,Copenhagen:

Headache

Migraine

Vasodilatation

Study placed in the following topic categories:

Signs and Symptoms

Migraine Disorders

Headache

Epoprostenol

Central Nervous System Diseases

Neurologic Manifestations

Headache Disorders, Primary

Pain

Brain Diseases

Headache Disorders

Additional relevant MeSH terms:

Therapeutic Uses

Hematologic Agents

Nervous System Diseases

Platelet Aggregation Inhibitors

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008