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

Familial Hemiplegic Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541736
• Other study ID #: FHM-GTN-2007-08
• Status: Completed
• Phase: N/A
• First received: October 9, 2007
• Last updated: May 28, 2008
• Start date: October 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Familial Hemiplegic Migraine
• Migraine Disorders
• Migraine with Aura

Intervention

Drug:
• Nitroglycerine
Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min

Locations

Country	Name	City	State
Denmark	Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital	Glostrup, Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Danish Headache Center	EUROHEAD

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine and associated symptoms		0-14 h
Primary	Migraine aura		0 - 14 h