PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers

Migraine Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00291395
• Other study ID #: KA05055
• Status: Terminated
• Phase: Phase 1
• First received: February 13, 2006
• Last updated: October 25, 2006
• Start date: September 2005

Study information

• Verified date: September 2005
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Headache
• Migraine

Intervention

Drug:
• PGI2

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache
Secondary	rCBF, blood flow, diameter of STA/RA, HR, BP