Back to resultsCalcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2.
Primary Purpose
Familial Hemiplegic Migraine
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CGRP
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Familial Hemiplegic Migraine focused on measuring Familial hemiplegic migraine type 1 and 2, CGRP, middle cerebral artery, superficial temporal artery, headache, genotype, 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 2) 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
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
NCT ID
NCT00358839
First Posted
July 31, 2006
Last Updated
November 9, 2006
Sponsor
Danish Headache Center
Collaborators
EUROHEAD
1. Study Identification
Unique Protocol Identification Number
NCT00358839
Brief Title
Calcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2.
Official Title
Calcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 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 Calcitonin Gene Related Peptide (CGRP)infusion.
Detailed Description
Calcitonin Gene Related Peptide (CGRP) induces migraine attacks indistinguishable from spontaneous attacks in approximately 50% of migraine sufferers. Treatment of spontaneous migraine attacks with an antagonist to CGRP is effective in many patients. These data show that CGRP 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 CGRP 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
Keywords
Familial hemiplegic migraine type 1 and 2, CGRP, middle cerebral artery, superficial temporal artery, headache, genotype, Healthy Volunteers
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CGRP
Primary Outcome Measure Information:
Title
headache and associated symptoms
Title
blood flow velocity of the middle cerebral artery
Title
diameter of the superficial temporal artery
Secondary Outcome Measure Information:
Title
MAP
Title
HR
10. Eligibility
Sex
All
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 2) 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
City
Glostrup, Copenhagen
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Calcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2.
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