PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers

This study has been terminated.

First Received on February 13, 2006. Last Updated on October 25, 2006 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind

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 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

No publications provided

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

Additional relevant MeSH terms:

Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 09, 2012