Calcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2.

Not Applicable

Completed

• Conditions: Familial Hemiplegic Migraine

• Registration Number: NCT00358839
• Lead Sponsor: Danish Headache Center

Brief Summary

The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to Calcitonin Gene Related Peptide (CGRP)infusion.

Detailed Description

Calcitonin Gene Related Peptide (CGRP) induces migraine attacks indistinguishable from spontaneous attacks in approximately 50% of migraine sufferers. Treatment of spontaneous migraine attacks with an antagonist to CGRP is effective in many patients. These data show that CGRP is involved in both initiation and maintenance of migraine attack.

The consequence of migraine gene mutations on relevant migraine pathways has never been tested. The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to CGRP infusion. The project will improve our understanding of the neurobiology of migraine and stimulate development of new treatment targets.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-31
• Study First Submitted QC: 2006-07-31
• Study First Posted: 2006-08-01
• Study Completion: 2006-10
• Status Verified: 2006-11
• Last Update Submitted: 2006-11-09
• Last Update Posted: 2006-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients: Diagnosis of familial hemiplegic migraine (IHS-classification criteria) caused by mutations in the CACNA1A gene and the ATP1A2 gene.

Controls: Healthy volunteers

Exclusion Criteria

Controls: No primary headache in their own history 2) 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

Primary Outcome Measures

Name	Time	Method
headache and associated symptoms
blood flow velocity of the middle cerebral artery
diameter of the superficial temporal artery

Secondary Outcome Measures

Name	Time	Method
MAP
HR

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Copenhagen, Denmark