- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00358839
Calcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2.
Study Overview
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Glostrup, Copenhagen, Denmark, 2600
- Danish Headache Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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headache and associated symptoms
|
blood flow velocity of the middle cerebral artery
|
diameter of the superficial temporal artery
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Secondary Outcome Measures
Outcome Measure |
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MAP
|
HR
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FHM-CGRP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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