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

November 11, 2024 updated by: Hospital Universitari Vall d'Hebron Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

440

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Patricia Pozo-Rosich, MD, PhD
  • Phone Number: (+34)934893000
  • Email: ppozo@vhebron.net

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall d'Hebron University Hospital
        • Contact:
          • Patricia Pozo-Rosich, MD, PhD
          • Phone Number: (+34)934893000
          • Email: ppozo@vhebron.net

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Migraine Patients
Patients, male and female, with Episodic migraine, all ages.
Diagnostic test: Saliva test
Sampling of CGRP in saliva and DNA blood test and sex hormones blood test.
Other Names:
  • Blood test
Control group
Male and female without migraine or headache
Diagnostic test: Saliva test
Sampling of CGRP in saliva and DNA blood test and sex hormones blood test.
Other Names:
  • Blood test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGRP level
Time Frame: Through study completion, an average of 1 year
Measure of CGRP in saliva
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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)
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2022

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

November 3, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)350/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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