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Calcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2.

NCT ID: NCT00358839

Last Updated: 2006-11-10

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-10-31

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 Calcitonin Gene Related Peptide (CGRP)infusion.

Detailed Description

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Calcitonin Gene Related Peptide (CGRP) induces migraine attacks indistinguishable from spontaneous attacks in approximately 50% of migraine sufferers. Treatment of spontaneous migraine attacks with an antagonist to CGRP is effective in many patients. These data show that CGRP 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 CGRP 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

Keywords

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Familial hemiplegic migraine type 1 and 2 CGRP middle cerebral artery superficial temporal artery headache genotype Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

SINGLE

Interventions

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CGRP

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 2) 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

Glostrup, Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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FHM-CGRP

Identifier Type: -

Identifier Source: org_study_id