Migraine-like Headache
Conditions
Brief summary
The hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation of brain vessels in migraine patients without aura.
Interventions
DRUGdinoprostone
intravenous injection 0.4 μgr/kg/min for 25 min
intravenous injection for 25 min
Sponsors
Troels Wienecke
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Denmark
Outcome results
None listed