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

This study has been completed.
Sponsor:
Collaborator:
EUROHEAD
Information provided by:
Danish Headache Center
ClinicalTrials.gov Identifier:
NCT00257985
First received: November 22, 2005
Last updated: July 31, 2006
Last verified: November 2005
  Purpose

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


Condition Intervention
Familial Hemiplegic Migraine Type 1 and 2
Healthy Volunteers
Drug: GTN

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2

Resource links provided by NLM:


Further study details as provided by Danish Headache Center:

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

Secondary Outcome Measures:
  • MAP, HR

Estimated Enrollment: 30
Study Start Date: April 2005
Estimated Study Completion Date: March 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257985

Locations
Denmark
Danish Headache Center, University of Copenhagen, Department of Neurology, Glostrup Hospital
Glostrup, Copenhagen, Denmark, DK-2600
Sponsors and Collaborators
Danish Headache Center
EUROHEAD
Investigators
Principal Investigator: Jakob Møller Hansen, MD Danish Headache Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00257985     History of Changes
Other Study ID Numbers: FHM-GTN 2005
Study First Received: November 22, 2005
Last Updated: July 31, 2006
Health Authority: Denmark: Den Centrale Videnskabsetiske Komité

Keywords provided by Danish Headache Center:
Familial hemiplegic migraine type 1 and 2
GTN
middle cerebral artery
superficial temporal artery
headache
genotype

Additional relevant MeSH terms:
Headache
Migraine Disorders
Migraine with Aura
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014