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

NCT ID: NCT06674772

Last Updated: 2024-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

440 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-29

Study Completion Date

2025-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Headache (Migraine) Migraine Migraine Headache Migraine with Aura Migraine Without Aura Episodic Migraine Chronic Migraine Headache Chronic Migraine, Headache Episodic Migraine Headache

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Migraine Patients

Patients, male and female, with Episodic migraine, all ages.

Saliva test

Intervention Type DIAGNOSTIC_TEST

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

Control group

Male and female without migraine or headache

Saliva test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Saliva test

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Blood test

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vall d'Hebron University Hospital

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Patricia Pozo-Rosich, MD, PhD

Role: CONTACT

(+34)934893000

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Patricia Pozo-Rosich, MD, PhD

Role: primary

(+34)934893000

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PR(AG)350/2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.