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OpenTrials
Completed

NCT Number: NCT01327118

Prostaglandin F2alpha in a Human Headache Model

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

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Key information

Conditions

Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostaglandin F2alpha

Drug

intravenous injection

Other names: Dinoprost

Isoton sodium chloride

Drug

intravenous injection

Other names: placebo

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

    Time frame: 24 h.

    incidence of headache

Secondary outcomes

  1. Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz)

    Time frame: 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.

  2. diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan

    Time frame: 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.

  3. mean arterial blood pressure (MAP), heart rate (HR), end-tidal partial pressure of pCO2 (PetCO2), transcutaneous arterial oxygen saturation (SAT) measured by ProPac Encore®

    Time frame: 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.

  4. electrocardiography (ECG)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 1, 2011
Registry last updated
Apr 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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