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

Condition(s) targeted: Familial Hemiplegic Migraine Type 1 and 2; Healthy Volunteers

Intervention: GTN (Drug)

Phase: N/A

Status: Completed

Sponsored by: Danish Headache Center

Official(s) and/or principal investigator(s):
Jakob Møller Hansen, MD, Principal Investigator, Affiliation: Danish Headache Center

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

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

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

Primary outcome: headache and associated symptoms , blood flow velocity of the middle cerebral artery, diameter of the superficial temporal artery

Secondary outcome: MAP, HR

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Danish Headache Center, University of Copenhagen, Department of Neurology, Glostrup Hospital, Glostrup, Copenhagen DK-2600, Denmark

Starting date: April 2005
Last updated: July 31, 2006