Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2

Not Applicable

Completed

• Conditions: Familial Hemiplegic Migraine Type 1 and 2; Healthy Volunteers

• Registration Number: NCT00257985
• 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 GTN infusion.

Detailed Description

Glyceryl trinitrate (GTN) induces migraine attacks indistinguishable from spontaneous attacks in approximately 80% of migraine sufferers. After systemic administration GTN is transformed to nitric oxide (NO). Treatment of spontaneous migraine attacks with an inhibitor of NO is effective in 60% of patients. These data show that NO 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 GTN infusion. The project will improve our understanding of the neurobiology of migraine and stimulate development of new treatment targets.

Study Timeline

• Study Start: 2005-04
• Status Verified: 2005-11
• Study First Submitted: 2005-11-22
• Study First Submitted QC: 2005-11-22
• Study First Posted: 2005-11-24
• Study Completion: 2006-03
• Last Update Submitted: 2006-07-31
• Last Update Posted: 2006-08-01

Recruitment & Eligibility

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

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

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: SINGLE_GROUP

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, University of Copenhagen, Department of Neurology, Glostrup Hospital; 🇩🇰 Glostrup, Copenhagen, Denmark