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Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

Primary Purpose

Headache, Migraine, Vasodilatation

Status

Unknown status

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Prostacyclin, PGI2

Placebo

About this trial

This is an interventional basic science trial for Headache focused on measuring Headache, Migraine, Vasodilatation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Danish Headache CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Active treatment

Placebo

Outcomes

Primary Outcome Measures

Headache and accompanying symptoms. Blood flow velocity in the middle cerebral artery, diameter changes in superficial temporal artery and radial artery.

Secondary Outcome Measures

Blood pressure, pulse

Full Information

NCT ID

NCT00510172

First Posted

July 30, 2007

Last Updated

July 30, 2007

Sponsor

Glostrup University Hospital, Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT00510172

Brief Title

Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

Official Title

Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

Study Type

Interventional

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Unknown status

Study Start Date

December 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Headache, Migraine, Vasodilatation

Keywords

Headache, Migraine, Vasodilatation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Active treatment

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Prostacyclin, PGI2

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

NaCL 0,9%

Primary Outcome Measure Information:

Title

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 Information:

Title

Blood pressure, pulse

Time Frame

100 min

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Troels Wienecke, MD

Phone

+ 45 43 23 45 14

trowie01@glo.regionh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Troels Wienecke, MD

Organizational Affiliation

Danish Headache Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Danish Headache Center

City

Copenhagen

State/Province

Glostrup

ZIP/Postal Code

DK-2600

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Troels Wienecke, MD

12. IPD Sharing Statement

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Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

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