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

This study has been completed.
Information provided by:
Danish Headache Center Identifier:
First received: July 31, 2006
Last updated: November 9, 2006
Last verified: November 2006

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
Endpoint Classification: Pharmacodynamics Study
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:

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:
  • MAP
  • HR

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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00358839

Danish Headache Center
Glostrup, Copenhagen, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Principal Investigator: Jakob Møller Hansen, MD Danish Headache Center
  More Information

No publications provided Identifier: NCT00358839     History of Changes
Other Study ID Numbers: FHM-CGRP
Study First Received: July 31, 2006
Last Updated: November 9, 2006
Health Authority: Denmark: Den Centrale Videnskabsetiske Komité

Keywords provided by Danish Headache Center:
Familial hemiplegic migraine type 1 and 2
middle cerebral artery
superficial temporal artery
Familial Hemiplegic Migraine Type 1 and 2
Healthy Volunteers

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents processed this record on February 27, 2015