Prostaglandin E2 in Migraine Suffers Without Aura.

Not Applicable

Completed

• Conditions: "Migraine-like" Headache
• Interventions: Drug: isoton sodium chloride; Drug: dinoprostone

• Registration Number: NCT01384812
• Lead Sponsor: Troels Wienecke

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-06-20
• Study First Submitted QC: 2011-06-28
• Study First Posted: 2011-06-29
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-08
• Last Update Posted: 2011-11-09

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Isoton sodium chloride	isoton sodium chloride	-
Prostin E2 (dinoprostone)	dinoprostone	-

Primary Outcome Measures

Name	Time	Method
Headache score on a 10-point verbal rating scale (VRS).	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 Outcome Measures

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

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Denmark