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Clinical Trials/NCT00687947
NCT00687947CompletedNot Applicable

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

Danish Headache Center1 site in 1 country30 target enrollmentStarted: May 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Migraine and associated symptoms

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

1

Experimental

MA-patients

Intervention: CGRP (Drug)

2

Experimental

FHM-patients

Intervention: CGRP (Drug)

3

Active Comparator

Healthy controls

Intervention: CGRP (Drug)

Outcomes

Primary Outcomes

Migraine and associated symptoms

Time Frame: 0-14 h

Secondary Outcomes

  • Migraine aura(0 - 14 h)

Investigators

Sponsor Class
Other

Study Sites (1)

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