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
  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
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.

  Eligibility

Genders Eligible for Study:   Both
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

No publications provided

ClinicalTrials.gov 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
CGRP
middle cerebral artery
superficial temporal artery
headache
genotype
Familial Hemiplegic Migraine Type 1 and 2
Healthy Volunteers

Additional relevant MeSH terms:
Headache
Migraine Disorders
Migraine with Aura
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Calcitonin Gene-Related Peptide
Calcitonin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 11, 2014