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Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

NCT ID: NCT00510172

Last Updated: 2007-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-09-30

Brief Summary

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

Detailed Description

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Conditions

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Headache Migraine Vasodilatation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Study Groups

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1

Active treatment

Group Type ACTIVE_COMPARATOR

Prostacyclin, PGI2

Intervention Type DRUG

10 ng/kg/min of epoprostenol (stable PGI2)

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

NaCL 0,9%

Interventions

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Prostacyclin, PGI2

10 ng/kg/min of epoprostenol (stable PGI2)

Intervention Type DRUG

Placebo

NaCL 0,9%

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Principal Investigators

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Troels Wienecke, MD

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

Locations

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Danish Headache Center

Copenhagen, Glostrup, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Troels Wienecke, MD

Role: CONTACT

[email protected]
+ 45 43 23 45 14

Other Identifiers

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KA-20060086

Identifier Type: -

Identifier Source: org_study_id