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Patients will be asked to visit the study center 2 times, the first time for clinical assessment and a second time for sample collection. Healthy controls will only be asked to visit the study center for sample collection. A sample of blood and saliva will be collected in order to measure CGRP levels and DNA and hormone testing.
CGRP is a neuropeptide related to migraine pathophysiology, which can be found in human saliva in both patients and healthy controls. The differences in CGRP levels may help us explain the differences in the treatment response.
A sample of saliva will be collected in order to measure CGRP levels and a blood sample will be collected in order to conduct a DNA test and hormones test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Migraine Patients | Patients, male and female, with Episodic migraine, all ages. |
| |
| Control group | Male and female without migraine or headache |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saliva test | Diagnostic Test | Sampling of CGRP in saliva and DNA blood test and sex hormones blood test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| CGRP level | Measure of CGRP in saliva | Through study completion, an average of 1 year |
| Hormone levels | Blood test to quantify female hormones (FSH, LH, estradiol, progesterone, prolactin) and male hormones (testosterone) in all participants except for prepubertal children. | Through study completion, an average of 1 year |
| DNA test | DNA testing for CGRP or its receptor related genes (CALCA, CALCB, CALCRL and RAMP1) | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Only cis-gender male and female will be included in the study due to hormone testing.
Males and females otherwise healthy with episodic and chronic migraine in different age groups will be included in the study. Controls matching age and sex will be selected for the control groups.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Pozo-Rosich, MD, PhD | Contact | (+34)934893000 | ppozo@vhebron.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vall d'Hebron University Hospital | Recruiting | Barcelona | Barcelona | 08035 | Spain |
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Blood and saliva samples will be retained.
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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