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

This study has been completed.

Sponsor:

Collaborator:

EUROHEAD

Information provided by:

Danish Headache Center

ClinicalTrials.gov Identifier:

NCT00358839

First received: July 31, 2006

Last updated: November 9, 2006

Last verified: November 2006

History of Changes

Purpose

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.

Condition	Intervention
Familial Hemiplegic Migraine	Drug: CGRP


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Educational/Counseling/Training
Official Title:	Calcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2.

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine sporadic hemiplegic migraine

MedlinePlus related topics: Genes and Gene Therapy Headache Migraine

Drug Information available for: Calcitonin Salmon calcitonin

Genetic and Rare Diseases Information Center resources: Hemiplegic Migraine Familial Hemiplegic Migraine Familial Hemiplegic Migraine Type 1

U.S. FDA Resources

Further study details as provided by Danish Headache Center:

Primary Outcome Measures:

headache and associated symptoms
blood flow velocity of the middle cerebral artery
diameter of the superficial temporal artery

Secondary Outcome Measures:


Estimated Enrollment:	20
Study Start Date:	July 2006
Estimated Study Completion Date:	October 2006

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358839

Locations


Denmark
Danish Headache Center
Glostrup, Copenhagen, Denmark, 2600

Sponsors and Collaborators

Danish Headache Center

EUROHEAD

Investigators


Principal Investigator:	Jakob Møller Hansen, MD	Danish Headache Center

More Information


ClinicalTrials.gov Identifier:	NCT00358839 History of Changes
Other Study ID Numbers:	FHM-CGRP
Study First Received:	July 31, 2006
Last Updated:	November 9, 2006

Keywords provided by Danish Headache Center:


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

Additional relevant MeSH terms:


Migraine Disorders Headache Migraine with Aura Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain	Neurologic Manifestations Signs and Symptoms Calcitonin Gene-Related Peptide Salmon calcitonin Calcitonin Vasodilator Agents Bone Density Conservation Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017

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