Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

Glostrup University Hospital, Copenhagen

Status: Unknown

Conditions: Vasodilatation; Migraine; Headache

Treatments: Drug: Prostacyclin, PGI2; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00510172

KA-20060086

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Active treatment

Treatment:

Drug: Prostacyclin, PGI2

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo