Prostaglandin F2alpha in a Human Headache Model
Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin F2alpha
1 other identifier
interventional
12
1 country
1
Brief Summary
The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of brain vessels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 29, 2011
CompletedFirst Posted
Study publicly available on registry
April 1, 2011
CompletedApril 14, 2011
July 1, 2010
3 months
March 29, 2011
April 13, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (4)
Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz)
in-hospital 2 h.
diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan
in-hospital 2 h.
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.
electrocardiography (ECG)
in-hospital 2 h.
Study Arms (2)
Isoton sodium chloride
PLACEBO COMPARATORProstaglandin F2alpha
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Danish Headache Center
Glostrup Municipality, 2600, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Troels Wienecke, MD,PhD
Danish Headache Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 29, 2011
First Posted
April 1, 2011
Study Start
September 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
April 14, 2011
Record last verified: 2010-07