Migraine-like Headache Clinical Trial
Official title:
Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin E2 in Migraine Suffers Without Aura.
| Verified date | November 2011 |
| Source | Danish Headache Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Danish Medicines Agency |
| Study type | Interventional |
The hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation of brain vessels in migraine patients without aura.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | July 2011 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Danish Headache Center | Glostrup |
| Lead Sponsor | Collaborator |
|---|---|
| Troels Wienecke |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Headache score on a 10-point verbal rating scale (VRS). | 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. | 24 h | No |
| Secondary | Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz). | 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. | 90 min | No |
| Secondary | Diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan. | 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. | 90 min | No |
| Secondary | Mean arterial blood pressure (MAP). | 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. | 90 min | Yes |
| Secondary | Electrocardiography (ECG). | 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. | 90 min | Yes |
| Secondary | Heart rate (HR). | 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. | 90 min | Yes |
| Secondary | End-tidal partial pressure of pCO2 (PetCO2). | 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. | 90 min | No |
| Secondary | Transcutaneous arterial oxygen saturation (SAT) | 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. | 90 min | Yes |