Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

Migraine Clinical Trial

Official title:

Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00510172
• Other study ID #: KA-20060086
• Status: Recruiting
• Phase: N/A
• First received: July 30, 2007
• Last updated: July 30, 2007
• Start date: December 2006
• Est. completion date: September 2007

Study information

• Verified date: July 2007
• Source: Glostrup University Hospital, Copenhagen
• Contact: Troels Wienecke, MD
• Phone: + 45 43 23 45 14
• Email: trowie01[@]glo.regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

We hypothesised that intravenous infusion of PGI2 induced headache or migraine and cranial vasodilatation in migraineurs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• migraine without aura and healthy apart from that

• age 18-55 years

• 50-100 kg

• Secure contraceptives

Exclusion Criteria:

• Tension Type Headache more than 3 time a month

• Other primary headaches

• Medication prior to the study (closer than 4 times plasma halflife)

• Migraine or headache 5 days prior to study.

• Hypertension (systolic BP >150 mmHg and/or diastolic BP >100 mmHg).

• Hypotension (systolic BP <90 mmHg and/or diastolic BP <50 mmHg).

• Heart-vessel disease of any kind incl cerebrovascular disease.

• Anamnestic or clinical signs of psychiatric disease or abuse.

• Anamnestic or clinical signs of disease of any kind relevant for participation in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders
• Vasodilatation

Intervention

Drug:
• Prostacyclin, PGI2
10 ng/kg/min of epoprostenol (stable PGI2)
• Placebo
NaCL 0,9%

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache and accompanying symptoms. Blood flow velocity in the middle cerebral artery, diameter changes in superficial temporal artery and radial artery.		14 hours
Secondary	Blood pressure, pulse		100 min