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

Primary Purpose

Familial Hemiplegic Migraine

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

About this trial

This is an interventional basic science trial for Familial Hemiplegic Migraine focused on measuring Familial Hemiplegic Migraine

Eligibility Criteria

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

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients

Controls

Arm Description

GTN-infusion

GTN-infusion

Outcomes

Primary Outcome Measures

Migraine and associated symptoms
Migraine aura

Secondary Outcome Measures

Full Information

First Posted
October 9, 2007
Last Updated
May 28, 2008
Sponsor
Danish Headache Center
Collaborators
EUROHEAD
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1. Study Identification

Unique Protocol Identification Number
NCT00541736
Brief Title
Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine
Official Title
Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Danish Headache Center
Collaborators
EUROHEAD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Hemiplegic Migraine
Keywords
Familial Hemiplegic Migraine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
GTN-infusion
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
GTN-infusion
Intervention Type
Drug
Intervention Name(s)
Nitroglycerine
Intervention Description
Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min
Primary Outcome Measure Information:
Title
Migraine and associated symptoms
Time Frame
0-14 h
Title
Migraine aura
Time Frame
0 - 14 h

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital
City
Glostrup, Copenhagen
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

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

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