Calcitonin Gene-related Peptide in Familial Hemiplegic Migraine (FHM) and Migraine With Aura (MA)

NCT ID: NCT00687947

Last Updated: 2009-08-03

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

2008-05-31

Study Completion Date

2008-08-31

Brief Summary

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

Detailed Description

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Calcitonin gene-related peptide (CGRP) induces migraine attacks indistinguishable from spontaneous attacks in a large proportion of migraine sufferers. Treatment of spontaneous migraine attacks with an inhibitor of CGRP is effective in many patients. These data show that CGRP is involved in migraine pathophysiology.

The importance of migraine genetics 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 Migraine With Aura Healthy

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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1

MA-patients

Group Type EXPERIMENTAL

CGRP

Intervention Type DRUG

CGRP (0.5 ug/min) infused intravenously over 20 min

2

FHM-patients

Group Type EXPERIMENTAL

CGRP

Intervention Type DRUG

CGRP (0.5 ug/min) infused intravenously over 20 min

3

Healthy controls

Group Type ACTIVE_COMPARATOR

CGRP

Intervention Type DRUG

CGRP (0.5 ug/min) infused intravenously over 20 min

Interventions

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CGRP

CGRP (0.5 ug/min) infused intravenously over 20 min

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of familial hemiplegic migraine (IHS-classification criteria)
* Diagnosis of migraine with aura(IHS-classification criteria)
* Healthy controls

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

Responsible Party

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

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

References

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Hansen JM, Thomsen LL, Olesen J, Ashina M. Familial hemiplegic migraine type 1 shows no hypersensitivity to nitric oxide. Cephalalgia. 2008 May;28(5):496-505. doi: 10.1111/j.1468-2982.2008.01559.x. Epub 2008 Mar 31.

Reference Type BACKGROUND
PMID: 18384418 (View on PubMed)

Hansen JM, Thomsen LL, Marconi R, Casari G, Olesen J, Ashina M. Familial hemiplegic migraine type 2 does not share hypersensitivity to nitric oxide with common types of migraine. Cephalalgia. 2008 Apr;28(4):367-75. doi: 10.1111/j.1468-2982.2008.01542.x. Epub 2008 Feb 22.

Reference Type BACKGROUND
PMID: 18294248 (View on PubMed)

Related Links

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http://www.glostruphospital.dk/danishheadachecenter/menu

The homepage of the Danish headache center, Glostrup, Copenhagen, Denmark

Other Identifiers

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FHM-CGRP-MA-2008

Identifier Type: -

Identifier Source: org_study_id

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