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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   

ChemIDplus related topics:   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
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 September 04, 2008




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