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

Danish Headache Center

Status: Completed

Conditions: Migraine With Aura; Healthy; Familial Hemiplegic Migraine

Treatments: Drug: CGRP

Study type: Interventional

Funder types: Other

Identifiers

NCT00687947

FHM-CGRP-MA-2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

1

Experimental group

Description:

MA-patients

Treatment:

Drug: CGRP

2

Experimental group

Description:

FHM-patients

Treatment:

Drug: CGRP

3

Active Comparator group

Description:

Healthy controls

Treatment:

Drug: CGRP