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Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine

NCT ID: NCT00541736

Last Updated: 2008-05-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-05-31

Brief Summary

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The aim of the present study is to explore the importance of migraine genes on the headache/migraine responses after GTN in FHM-patients and healthy volunteers.

Detailed Description

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Glyceryl trinitrate (GTN) induces migraine attacks indistinguishable from spontaneous attacks in approximately 80% of migraine sufferers. After systemic administration GTN is transformed to nitric oxide (NO). Treatment of spontaneous migraine attacks with an inhibitor of NO is effective in 60% of patients. These data show that NO is involved in both initiation and maintenance of migraine attack.

The importance of migraine genes is disputed. Evidence from FHM patients with known mutations indicates that migraine pathways in FHM may be different from normal migraine. The aim of the present study is to examine whether this difference also exists in FHM patients without known mutations. The project will improve our understanding of the neurobiology of migraine and stimulate development of new treatment targets.

Conditions

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Familial Hemiplegic Migraine

Keywords

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Familial Hemiplegic Migraine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients

GTN-infusion

Group Type EXPERIMENTAL

Nitroglycerine

Intervention Type DRUG

Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min

Controls

GTN-infusion

Group Type ACTIVE_COMPARATOR

Nitroglycerine

Intervention Type DRUG

Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min

Interventions

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Nitroglycerine

Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of familial hemiplegic migraine (IHS-classification criteria)

Exclusion Criteria

Patients and controls:

* A history of cerebrovascular disease and other CNS- disease
* A history of serious somatic and mental disease
* A history suggesting ischaemic heart disease
* A history of hypo- or hypertension
* Daily intake of medication apart from oral contraceptives
* Abuse of alcohol or medicine (opioid analgesics).
* Pregnant or breastfeeding women.

On the study day:

* No intake of a simple analgesic in the previous 48 hours
* No headache in the previous 48 hours
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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EUROHEAD

OTHER

Sponsor Role collaborator

Danish Headache Center

OTHER

Sponsor Role lead

Principal Investigators

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Jakob Møller Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

Locations

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Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital

Glostrup, Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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FHM-GTN-2007-08

Identifier Type: -

Identifier Source: org_study_id