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

Not Applicable

Completed

• Conditions: Familial Hemiplegic Migraine; Migraine With Aura; Healthy
• Interventions: Drug: CGRP

• Registration Number: NCT00687947
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-30
• Study First Posted: 2008-06-02
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-31
• Last Update Posted: 2009-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CGRP	MA-patients
2	CGRP	FHM-patients
3	CGRP	Healthy controls

Primary Outcome Measures

Name	Time	Method
Migraine and associated symptoms	0-14 h

Secondary Outcome Measures

Name	Time	Method
Migraine aura	0 - 14 h

Trial Locations

Locations (1)

Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital; 🇩🇰 Glostrup, Copenhagen, Denmark