PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers

This study has been terminated.

Sponsor:

Information provided by:

Danish Headache Center

ClinicalTrials.gov Identifier:

NCT00291395

First received: February 13, 2006

Last updated: October 25, 2006

Last verified: September 2005

History of Changes

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 1


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

Resource links provided by NLM:

MedlinePlus related topics: Headache

Drug Information available for: 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 (Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

Additional relevant MeSH terms:


Headache Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms

ClinicalTrials.gov processed this record on July 18, 2017

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