Molecular Phenotyping of Migraine Patients According to Sex and Age Through CGRP Quantification
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Saliva test.
- Who it may be relevant to
- Registry conditions: Headache (Migraine), Migraine, Migraine Headache, Migraine with Aura. Basic parameters: 6 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Fenotipado Molecular De Pacientes Con Migraña Según Edad Y Sexo a Través De La Cuantificación De CGRP En Saliva Para Realizar Medicina De Precisión: Estudio FAST
Overview
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 test Saliva test
Sampling of CGRP in saliva and DNA blood test and sex hormones blood test.
Primary outcome measures
- CGRP level [Time frame: Through study completion, an average of 1 year]
- Hormone levels [Time frame: Through study completion, an average of 1 year]
- DNA test [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Spain · 1 center
- Vall d'Hebron University Hospital — Barcelona
Identifiers
NCT: NCT06674772 · PR(AG)350/2022