PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers - Tabular View

Tracking Information

First Received Date ^ICMJE

February 13, 2006

Last Updated Date

October 25, 2006

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Headache

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00291395 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers

Official Title ^ICMJE

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Double-Blind, Placebo Control, Crossover Assignment

Condition ^ICMJE

Headache
Migraine

Intervention ^ICMJE

Drug: PGI2

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00291395

Responsible Party

Study ID Numbers ^ICMJE

KA05055

Study Sponsor ^ICMJE

Danish Headache Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Troels Wienecke, MD

Danish Headache Center

Information Provided By

Danish Headache Center

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP