Headache (Migraine), Migraine, Migraine Headache, Migraine with Aura, Migraine Without Aura, Episodic Migraine, Chronic Migraine Headache, Chronic Migraine, Headache, Episodic Migraine Headache
Conditions
Keywords
Migraine, CGRP, saliva
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTSaliva test
Sampling of CGRP in saliva and DNA blood test and sex hormones blood test.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Migraine patients according to ICHD-3 criteria * Healthy controls paired to patient age and sex, without headache and without first degree family history of headache.
Exclusion criteria
* Presence of any major medical or neurological illness. * Presence of any salivary gland malfunction. * Abuse or dependence to tobacco, alcohol or any drug in the previous 12 months before the enrollment. * Active migraine preventive treatment. * Pregnant or breastfeeding female.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CGRP level | Through study completion, an average of 1 year | Measure of CGRP in saliva |
| Hormone levels | Through study completion, an average of 1 year | Blood test to quantify female hormones (FSH, LH, estradiol, progesterone, prolactin) and male hormones (testosterone) in all participants except for prepubertal children. |
| DNA test | Through study completion, an average of 1 year | DNA testing for CGRP or its receptor related genes (CALCA, CALCB, CALCRL and RAMP1) |
Countries
Spain
Contacts
Primary ContactPatricia Pozo-Rosich, MD, PhD
Outcome results
None listed