Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2
Tracking Information | |||||
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First Received Date ICMJE | November 22, 2005 | ||||
Last Updated Date | July 31, 2006 | ||||
Start Date ICMJE | April 2005 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
headache and associated symptoms , blood flow velocity of the middle cerebral artery, diameter of the superficial temporal artery | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00257985 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
MAP, HR | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2 | ||||
Official Title ICMJE | Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2 | ||||
Brief Summary | The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to GTN infusion. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Educational/Counseling/Training |
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Condition ICMJE |
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Intervention ICMJE | Drug: GTN | ||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 30 | ||||
Completion Date | March 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | 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:
On the study day:
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Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Denmark | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00257985 | ||||
Other Study ID Numbers ICMJE | FHM-GTN 2005 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Danish Headache Center | ||||
Collaborators ICMJE | EUROHEAD | ||||
Investigators ICMJE |
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Information Provided By | Danish Headache Center | ||||
Verification Date | November 2005 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |