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

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ClinicalTrials.gov Identifier: NCT00687947
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : August 3, 2009
Sponsor:
Collaborator:
EUROHEAD
Information provided by:
Danish Headache Center

Brief Summary:
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 or disease Intervention/treatment Phase
Familial Hemiplegic Migraine Migraine With Aura Healthy Drug: CGRP Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: CGRP-induced Headache in Patients With Familial Hemiplegic Migraine, Migraine With Aura and Healthy Controls
Study Start Date : May 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Migraine and associated symptoms [ Time Frame: 0-14 h ]

Secondary Outcome Measures :
  1. Migraine aura [ Time Frame: 0 - 14 h ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: August 3, 2009
Last Verified: July 2009

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
Bone Density Conservation Agents
Physiological Effects of Drugs