Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine

Not Applicable

Completed

• Conditions: Familial Hemiplegic Migraine
• Interventions: Drug: Nitroglycerine

• Registration Number: NCT00541736
• Lead Sponsor: Danish Headache Center

Brief Summary

The aim of the present study is to explore the importance of migraine genes on the headache/migraine responses after GTN in FHM-patients and healthy volunteers.

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 importance of migraine genes 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: 2007-10
• Study First Submitted: 2007-10-09
• Study First Submitted QC: 2007-10-09
• Study First Posted: 2007-10-10
• Status Verified: 2008-05
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Last Update Submitted: 2008-05-28
• Last Update Posted: 2008-05-29

Recruitment & Eligibility

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

Inclusion Criteria

• Diagnosis of familial hemiplegic migraine (IHS-classification criteria)

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
Patients	Nitroglycerine	GTN-infusion
Controls	Nitroglycerine	GTN-infusion

Primary Outcome Measures

Name	Time	Method
Migraine aura	0 - 14 h
Migraine and associated symptoms	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