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Calcitonin Gene-related Peptide in Familial Hemiplegic Migraine (FHM) and Migraine With Aura (MA) (CGRP-2008)

This study has been completed.
Sponsor:
Collaborator:
EUROHEAD
Information provided by:
Danish Headache Center
ClinicalTrials.gov Identifier:
NCT00687947
First received: May 28, 2008
Last updated: July 31, 2009
Last verified: July 2009
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: CGRP-induced Headache in Patients With Familial Hemiplegic Migraine, Migraine With Aura and Healthy Controls

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

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
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MA-patients
 Drug: CGRP
CGRP (0.5 ug/min) infused intravenously over 20 min
Experimental: 2
FHM-patients
 Drug: CGRP
CGRP (0.5 ug/min) infused intravenously over 20 min
Active Comparator: 3
Healthy controls
 Drug: CGRP
CGRP (0.5 ug/min) infused intravenously over 20 min

Detailed Description:

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.

  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

Locations
Denmark
Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital
Glostrup, Copenhagen, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
EUROHEAD
Investigators
Principal Investigator: Jakob Møller Hansen, MD Danish Headache Center
  More Information

Additional 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:

Responsible Party: Jakob Møller Hansen, MD, Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital
ClinicalTrials.gov Identifier: NCT00687947     History of Changes
Other Study ID Numbers: FHM-CGRP-MA-2008
Study First Received: May 28, 2008
Last Updated: July 31, 2009
Health Authority: Denmark: Ethics Committee

Keywords provided by Danish Headache Center:
FHM
MA
healthy controls
CGRP

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
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 May 16, 2013