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

Primary Purpose

Familial Hemiplegic Migraine Type 1 and 2, Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
GTN
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Familial Hemiplegic Migraine Type 1 and 2 focused on measuring Familial hemiplegic migraine type 1 and 2, GTN, middle cerebral artery, superficial temporal artery, headache, genotype

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Danish Headache Center, University of Copenhagen, Department of Neurology, Glostrup Hospital

Outcomes

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

Full Information

First Posted
November 22, 2005
Last Updated
July 31, 2006
Sponsor
Danish Headache Center
Collaborators
EUROHEAD
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1. Study Identification

Unique Protocol Identification Number
NCT00257985
Brief Title
Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2
Official Title
Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Danish Headache Center
Collaborators
EUROHEAD

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Hemiplegic Migraine Type 1 and 2, Healthy Volunteers
Keywords
Familial hemiplegic migraine type 1 and 2, GTN, middle cerebral artery, superficial temporal artery, headache, genotype

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GTN
Primary Outcome Measure Information:
Title
headache and associated symptoms , blood flow velocity of the middle cerebral artery, diameter of the superficial temporal artery
Secondary Outcome Measure Information:
Title
MAP, HR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob Møller Hansen, MD
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Center, University of Copenhagen, Department of Neurology, Glostrup Hospital
City
Glostrup, Copenhagen
ZIP/Postal Code
DK-2600
Country
Denmark

12. IPD Sharing Statement

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

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