Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2
Information source: Glostrup University Hospital, Copenhagen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Headache; Migraine; Vasodilatation
Intervention: Prostacyclin, PGI2 (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Glostrup University Hospital, Copenhagen Official(s) and/or principal investigator(s):
Troels Wienecke, MD, Principal Investigator, Affiliation: Danish Headache Center
Overall contact:
Troels Wienecke, MD, Phone: + 45 43 23 45 14, Email: trowie01@glo.regionh.dk
Summary
We hypothesised that intravenous infusion of PGI2 induced headache or migraine and cranial
vasodilatation in migraineurs.
Clinical Details
Official title: Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Basic Science
Primary outcome: Headache and accompanying symptoms. Blood flow velocity in the middle cerebral artery, diameter changes in superficial temporal artery and radial artery.
Secondary outcome: Blood pressure, pulse
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Troels Wienecke, MD, Phone: + 45 43 23 45 14, Email: trowie01@glo.regionh.dk
Danish Headache Center, Copenhagen, Glostrup DK-2600, Denmark; Recruiting
Troels Wienecke, MD, Principal Investigator
Additional Information
Starting date: December 2006
Last updated: July 30, 2007
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