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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257985
• Other study ID #: FHM-GTN 2005
• Status: Completed
• Phase: N/A
• First received: November 22, 2005
• Last updated: July 31, 2006
• Start date: April 2005
• Est. completion date: March 2006

Study information

• Verified date: November 2005
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Den Centrale Videnskabsetiske Komité
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to GTN infusion.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Familial Hemiplegic Migraine Type 1 and 2
• Headache
• Healthy Volunteers
• Migraine Disorders
• Migraine with Aura

Intervention

Drug:
• GTN

Locations

Country	Name	City	State
Denmark	Danish Headache Center, University of Copenhagen, 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	headache and associated symptoms , blood flow velocity of the middle cerebral artery, diameter of the superficial temporal artery
Secondary	MAP, HR