Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2

NCT ID: NCT00257985

Last Updated: 2006-08-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-03-31

Brief Summary

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The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to GTN infusion.

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 consequence of migraine gene mutations on relevant migraine pathways has never been tested. The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to GTN infusion. 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 Type 1 and 2 Healthy Volunteers

Keywords

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Familial hemiplegic migraine type 1 and 2 GTN middle cerebral artery superficial temporal artery headache genotype

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

ECT

Blinding Strategy

SINGLE

Interventions

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GTN

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients: Diagnosis of familial hemiplegic migraine (IHS-classification criteria) caused by mutations in the CACNA1A gene and the ATP1A2 gene.

Controls: healthy volunteers

Exclusion Criteria

Controls: No primary headache in their own history

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
Minimum Eligible Age

0 Years

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, Department of Neurology, Glostrup Hospital

Glostrup, Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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FHM-GTN 2005

Identifier Type: -

Identifier Source: org_study_id