Prostaglandin F2alpha in a Human Headache Model

Headache Clinical Trial

Official title:

Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin F2alpha

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327118
• Other study ID #: DHC-PGF2-2010
• Status: Completed
• Phase: N/A
• First received: March 29, 2011
• Last updated: April 13, 2011
• Start date: September 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2010
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• 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 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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Headache

Intervention

Drug:
• Prostaglandin F2alpha
intravenous injection
• Isoton sodium chloride
intravenous injection

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 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	incidence of headache	24 h.	No
Secondary	Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz)	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.	in-hospital 2 h.	No
Secondary	diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan	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.	in-hospital 2 h.	No
Secondary	mean arterial blood pressure (MAP), heart rate (HR), end-tidal partial pressure of pCO2 (PetCO2), transcutaneous arterial oxygen saturation (SAT) measured by ProPac Encore®	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.	in-hospital 2 h.	Yes
Secondary	electrocardiography (ECG)	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.	in-hospital 2 h.	Yes