Prostaglandin F2alpha in a Human Headache Model

Not Applicable

Completed

• Conditions: Headache
• Interventions: Drug: Isoton sodium chloride; Drug: Prostaglandin F2alpha

• Registration Number: NCT01327118
• Lead Sponsor: Danish Headache Center

Brief Summary

The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of brain vessels.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-07
• Study Start: 2010-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-03-30
• Study First Posted: 2011-04-01
• Last Update Submitted: 2011-04-13
• Last Update Posted: 2011-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

• Primary Headache
• Headache on the day of the investigation
• Hypertension
• Hypotension
• Pregnant/nursing
• Daily intake of medication (except oral contraceptives)
• Cardiovascular or central nervous system (CNS) disease
• Drug/alcohol abuse
• Psychiatric disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Isoton sodium chloride	Isoton sodium chloride	-
Prostaglandin F2alpha	Prostaglandin F2alpha	-

Primary Outcome Measures

Name	Time	Method
Headache score on a 10-point verbal rating scale (VRS) 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache	24 h.	incidence of headache

Secondary Outcome Measures

Name	Time	Method
diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan	in-hospital 2 h.	changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz)	in-hospital 2 h.	changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
mean arterial blood pressure (MAP), heart rate (HR), end-tidal partial pressure of pCO2 (PetCO2), transcutaneous arterial oxygen saturation (SAT) measured by ProPac Encore®	in-hospital 2 h.	changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
electrocardiography (ECG)	in-hospital 2 h.	changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Denmark