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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 Migraine
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 May 22, 2013