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

This study has been completed.
Sponsor:
Collaborator:
EUROHEAD
Information provided by:
Danish Headache Center
ClinicalTrials.gov Identifier:
NCT00541736
First received: October 9, 2007
Last updated: May 28, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention
Familial Hemiplegic Migraine
Drug: Nitroglycerine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine

Resource links provided by NLM:


Further study details as provided by Danish Headache Center:

Primary Outcome Measures:
  • Migraine and associated symptoms [ Time Frame: 0-14 h ]
  • Migraine aura [ Time Frame: 0 - 14 h ]

Enrollment: 30
Study Start Date: October 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients
GTN-infusion
Drug: Nitroglycerine
Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min
Active Comparator: Controls
GTN-infusion
Drug: Nitroglycerine
Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541736

Locations
Denmark
Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital
Glostrup, Copenhagen, Denmark, 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: NCT00541736     History of Changes
Other Study ID Numbers: FHM-GTN-2007-08
Study First Received: October 9, 2007
Last Updated: May 28, 2008
Health Authority: Denmark: Ethics Committee

Keywords provided by Danish Headache Center:
Familial Hemiplegic Migraine

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 July 22, 2014