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

November 22, 2005
July 31, 2006
April 2005
 
headache and associated symptoms , blood flow velocity of the middle cerebral artery, diameter of the superficial temporal artery
Same as current
Complete list of historical versions of study NCT00257985 on ClinicalTrials.gov Archive Site
MAP, HR
Same as current
 
 
 
Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2
Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2

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

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.

Interventional
 
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
  • Familial Hemiplegic Migraine Type 1 and 2
  • Healthy Volunteers
Drug: GTN
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2006
 

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
Both
 
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00257985
FHM-GTN 2005
 
 
Danish Headache Center
EUROHEAD
Principal Investigator: Jakob Møller Hansen, MD Danish Headache Center
Danish Headache Center
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP