PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers

This study has been terminated.

Sponsored by:	Danish Headache Center
Information provided by:	Danish Headache Center
ClinicalTrials.gov Identifier:	NCT00291395

Purpose

Before , during and after intravenous administration of PGI2 we score/measure headache, rCBF, blood flow in middle cerebral artery and diameter of superficial temporal artery/radial artery and correlate that to known patophysiology of headache to see if PGI2 is involved in headache pathophysiology.

Condition	Intervention	Phase
Headache Migraine	Drug: PGI2	Phase I

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Epoprostenol Epoprostenol sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Crossover Assignment

Further study details as provided by Danish Headache Center:

Primary Outcome Measures:

Headache

Secondary Outcome Measures:

rCBF, blood flow, diameter of STA/RA, HR, BP

Estimated Enrollment:	12
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteers,

Exclusion Criteria:

Primary headache,
headache on the day of investigation,
Hypertension,
hypotension,
pregnant/nursing
Daily intake of medication (except oral contraceptives)
Cardiovascular or CNS disease
Drug/Alcohol abuse
Psychiatric disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291395

Locations

Denmark
Danish Headache Center
Glostrup, Denmark, DK-2600

Sponsors and Collaborators

Danish Headache Center

Investigators

Principal Investigator:

Troels Wienecke, MD

Danish Headache Center

More Information

Study ID Numbers:	KA05055
Study First Received:	February 13, 2006
Last Updated:	October 25, 2006
ClinicalTrials.gov Identifier:	NCT00291395
Health Authority:	Denmark: Ethics Committee

Study placed in the following topic categories:

Signs and Symptoms
Migraine Disorders
Headache
Epoprostenol
Central Nervous System Diseases
Neurologic Manifestations

Headache Disorders, Primary
Pain
Healthy
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009