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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00541736
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : May 29, 2008
Sponsor:
Collaborator:
EUROHEAD
Information provided by:
Danish Headache Center

Tracking Information
First Submitted Date  ICMJE October 9, 2007
First Posted Date  ICMJE October 10, 2007
Last Update Posted Date May 29, 2008
Study Start Date  ICMJE October 2007
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2007)
  • Migraine and associated symptoms [ Time Frame: 0-14 h ]
  • Migraine aura [ Time Frame: 0 - 14 h ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine
Official Title  ICMJE Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Familial Hemiplegic Migraine
Intervention  ICMJE Drug: Nitroglycerine
Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min
Study Arms  ICMJE
  • Experimental: Patients
    GTN-infusion
    Intervention: Drug: Nitroglycerine
  • Active Comparator: Controls
    GTN-infusion
    Intervention: Drug: Nitroglycerine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2007)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00541736
Other Study ID Numbers  ICMJE FHM-GTN-2007-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Danish Headache Center
Collaborators  ICMJE EUROHEAD
Investigators  ICMJE
Principal Investigator: Jakob Møller Hansen, MD Danish Headache Center
PRS Account Danish Headache Center
Verification Date May 2008

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