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NCT Number: NCT06674772

Molecular Phenotyping of Migraine Patients According to Sex and Age Through CGRP Quantification

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.

Recruiting

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Key information

Conditions

Headache (Migraine) Brain Diseases Central Nervous System Diseases Chronic Migraine Headache Chronic Migraine, Headache Episodic Migraine Episodic Migraine Headache Headache Headache Disorders Headache Disorders, Primary Migraine Migraine Disorders Migraine Headache Migraine With Aura Migraine Without Aura Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location status: Recruiting

Location contact

Patricia Pozo-Rosich, MD, PhD

CONTACT

[email protected]

(+34)934893000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saliva test

Diagnostic Test

Sampling of CGRP in saliva and DNA blood test and sex hormones blood test.

Other names: Blood test

Primary outcomes

  1. CGRP level

    Time frame: Through study completion, an average of 1 year

    Measure of CGRP in saliva

  2. Hormone levels

    Time frame: 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.

  3. DNA test

    Time frame: Through study completion, an average of 1 year

    DNA testing for CGRP or its receptor related genes (CALCA, CALCB, CALCRL and RAMP1)

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Pozo-Rosich, MD, PhD

CONTACT

[email protected]

(+34)934893000

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study 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

Acronym: FAST

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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