Completed

NCT Number: NCT01384812

Prostaglandin E2 in Migraine Suffers Without Aura.

The hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation of brain vessels in migraine patients without aura.

Completed

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Key information

Conditions

"Migraine-like" Headache

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Glostrup Municipality, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with migraine without aura

Exclusion criteria

Tension type headache more than x 3 per month
Other forms for primary headache
Headache 24 h before the day of the investigation
Migraine 48 h before the day of the investigation
Hypertension
Hypotension
Pregnant/nursing
Daily intake of medication (except oral contraceptives and migraine rescue medicine during migraine attack)
Cardiovascular or central nervous system (CNS) disease
Drug/alcohol abuse
Psychiatric disease
Asthma or any other lung diseases

Treatment and study plan

Dinoprostone

Drug

intravenous injection 0.4 μgr/kg/min for 25 min

Other names: Prostin E2

Isoton sodium chloride

Drug

intravenous injection for 25 min

Other names: placebo

Primary outcomes

Headache score on a 10-point verbal rating scale (VRS).

Time frame: 24 h

Incidence of headache 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.

Secondary outcomes

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

Time frame: 90 min

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

Time frame: 90 min

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).

Time frame: 90 min

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).

Time frame: 90 min

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.
Heart rate (HR).

Time frame: 90 min

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.
End-tidal partial pressure of pCO2 (PetCO2).

Time frame: 90 min

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.
Transcutaneous arterial oxygen saturation (SAT)

Time frame: 90 min

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

Troels Wienecke

Other

Registry information

Official study title

Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin E2 in Migraine Suffers Without Aura.

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jun 29, 2011
Registry last updated: Nov 9, 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.