Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2 - Tabular View

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Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

This study is currently recruiting participants.

Study NCT00510172. Last updated on July 30, 2007. Information provided by Glostrup University Hospital,Copenhagen

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

Official Title ^†

Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

Brief Summary

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

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Basic Science, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Primary Outcome Measure ^†

Headache and accompanying symptoms. Blood flow velocity in the middle cerebral artery, diameter changes in superficial temporal artery and radial artery. [ Time Frame: 14 hours ]

Secondary Outcome Measure ^†

Blood pressure, pulse [ Time Frame: 100 min ]

Condition ^†

Headache
Migraine
Vasodilatation

Intervention ^†

Drug: Prostacyclin, PGI2
Drug: Placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

December 2006

Completion Date

September 2007

Eligibility 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.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Troels Wienecke, MD

+ 45 43 23 45 14

trowie01@glo.regionh.dk

Location Countries ^†

Denmark

Administrative Information Fields

NCT ID ^†

NCT00510172

Organization ID

KA-20060086

Secondary IDs ^††

Study Sponsor ^†

Glostrup University Hospital,Copenhagen

Collaborators ^††

Investigators ^†

Principal Investigator:

Troels Wienecke, MD

Danish Headache Center

Information Provided By

Glostrup University Hospital,Copenhagen

Verification Date

July 2007

First Received Date ^†

July 30, 2007

Last Updated Date

July 30, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.