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Completed

NCT Number: NCT00687947

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

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.

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Key information

Conditions

Familial Hemiplegic Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Healthy Migraine Disorders Migraine With Aura Nervous System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital

Glostrup, Copenhagen, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CGRP

Drug

CGRP (0.5 ug/min) infused intravenously over 20 min

Primary outcomes

  1. Migraine and associated symptoms

    Time frame: 0-14 h

Secondary outcomes

  1. Migraine aura

    Time frame: 0 - 14 h

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Collaborators

  • EUROHEAD

Registry information

Official study title

CGRP-induced Headache in Patients With Familial Hemiplegic Migraine, Migraine With Aura and Healthy Controls

Acronym: CGRP-2008

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 2, 2008
Registry last updated
Aug 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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