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

October 9, 2007
May 28, 2008
October 2007
May 2008   (final data collection date for primary outcome measure)
  • Migraine and associated symptoms [ Time Frame: 0-14 h ]
  • Migraine aura [ Time Frame: 0 - 14 h ]
Same as current
Complete list of historical versions of study NCT00541736 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine
Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Familial Hemiplegic Migraine
Drug: Nitroglycerine
Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min
  • Experimental: Patients
    GTN-infusion
    Intervention: Drug: Nitroglycerine
  • Active Comparator: Controls
    GTN-infusion
    Intervention: Drug: Nitroglycerine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00541736
FHM-GTN-2007-08
No
Not Provided
Danish Headache Center
EUROHEAD
Principal Investigator: Jakob Møller Hansen, MD Danish Headache Center
Danish Headache Center
May 2008

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