Calcitonin Gene-Related Peptide in Familial Hemiplegic Migraine (FHM) and Migraine With Aura (MA) - Full Text View

Sponsors and Collaborators:	Danish Headache Center EUROHEAD-partners
Information provided by:	Danish Headache Center
ClinicalTrials.gov Identifier:	NCT00687947

Purpose

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.

Condition	Intervention
Familial Hemiplegic Migraine Migraine With Aura Healthy	Drug: CGRP

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Calcitonin Calcitonin human Fortical

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	CGRP-Induced Headache in Patients With Familial Hemiplegic Migraine, Migraine With Aura and Healthy Controls

Further study details as provided by Danish Headache Center:

Primary Outcome Measures:

Migraine and associated symptoms [ Time Frame: 0-14 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Migraine aura [ Time Frame: 0 - 14 h ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	May 2008
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MA-patients	Drug: CGRP CGRP (0.5 ug/min) infused intravenously over 20 min
2: Experimental FHM-patients	Drug: CGRP CGRP (0.5 ug/min) infused intravenously over 20 min
3: Active Comparator Healthy controls	Drug: CGRP CGRP (0.5 ug/min) infused intravenously over 20 min

Detailed Description:

Calcitonion 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687947

Contacts

Contact: Jakob Møller Hansen, MD

45-4323-2713

jamoha01@glo.regionh.dk

Locations

Denmark
Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital	Recruiting
Glostrup, Copenhagen, Denmark, 2600
Principal Investigator: Jakob Møller Hansen, MD

Sponsors and Collaborators

Danish Headache Center

EUROHEAD-partners

Investigators

Principal Investigator:

Jakob Møller Hansen, MD

Danish Headache Center

More Information

The Lundbeck Foundation Center for Neurovascular Signaling (LUCENS) This link exits the ClinicalTrials.gov site

The homepage of the Danish headache center, Glostrup, Copenhagen, Denmark This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2008 Mar 31.

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. Epub 2008 Feb 22.

Responsible Party:	Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital ( Jakob Møller Hansen, MD )
Study ID Numbers:	FHM-CGRP-MA-2008
Study First Received:	May 28, 2008
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00687947
Health Authority:	Denmark: Ethics Committee

Keywords provided by Danish Headache Center:

FHM
MA
healthy controls
CGRP

Study placed in the following topic categories:

Calcitonin Gene-Related Peptide
Calcitonin
Migraine Disorders
Headache
Central Nervous System Diseases
Headache Disorders, Primary

Migraine with Aura
Healthy
Brain Diseases
Salmon calcitonin
Headache Disorders

Additional relevant MeSH terms:

Vasodilator Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009