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

Tracking Information

First Received Date ^ICMJE

July 30, 2007

Last Updated Date

July 30, 2007

Start Date ^ICMJE

December 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Blood pressure, pulse [ Time Frame: 100 min ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Headache
Migraine
Vasodilatation

Intervention ^ICMJE

Drug: Prostacyclin, PGI2
Drug: Placebo

Study Arms / Comparison Groups

Active Comparator: Active treatment
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact: Troels Wienecke, MD

+ 45 43 23 45 14

trowie01@glo.regionh.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00510172

Responsible Party

Study ID Numbers ^ICMJE

KA-20060086

Study Sponsor ^ICMJE

Glostrup University Hospital,Copenhagen

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Troels Wienecke, MD

Danish Headache Center

Information Provided By

Glostrup University Hospital,Copenhagen

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP