Calcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2.
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ClinicalTrials.gov Identifier: NCT00358839 |
Recruitment Status
:
Completed
First Posted
: August 1, 2006
Last Update Posted
: November 10, 2006
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Familial Hemiplegic Migraine | Drug: CGRP | Not Applicable |
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 : | Interventional (Clinical Trial) |
Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Educational/Counseling/Training |
Official Title: | Calcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2. |
Study Start Date : | July 2006 |
Study Completion Date : | October 2006 |

- headache and associated symptoms
- blood flow velocity of the middle cerebral artery
- diameter of the superficial temporal artery
- MAP
- HR

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358839
Denmark | |
Danish Headache Center | |
Glostrup, Copenhagen, Denmark, 2600 |
Principal Investigator: | Jakob Møller Hansen, MD | Danish Headache Center |
ClinicalTrials.gov Identifier: | NCT00358839 History of Changes |
Other Study ID Numbers: |
FHM-CGRP |
First Posted: | August 1, 2006 Key Record Dates |
Last Update Posted: | November 10, 2006 |
Last Verified: | November 2006 |
Keywords provided by Danish Headache Center:
Familial hemiplegic migraine type 1 and 2 CGRP middle cerebral artery superficial temporal artery |
headache genotype Healthy Volunteers |
Additional relevant MeSH terms:
Migraine Disorders Headache Migraine with Aura Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain |
Neurologic Manifestations Signs and Symptoms Salmon calcitonin Calcitonin Calcitonin Gene-Related Peptide Bone Density Conservation Agents Physiological Effects of Drugs Vasodilator Agents |