Tear Biomarkers for Migraine (TEAR)

July 9, 2026 updated by: Vollono Catello, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Novel Diagnostic and Treatment Response Biomarkers in Tear Fluid of Migraine Patients

The goal of this observational monocentric study is to investigate tear and serum biomarkers in patients with migraine compared with healthy controls, and to explore their potential diagnostic, clinical, and predictive value. In addition to the cross-sectional evaluation, a longitudinal subgroup analysis will be conducted to assess biomarker changes over time during treatment with anti- Calcitonin Gene-Related Peptide (anti-CGRP) therapies.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with migraine and healthy controls

Description

Inclusion criteria patients with migraine

  • Male or female participants aged ≥ 18 years;
  • Diagnosis of migraine according to International Classification of Headache Disorders (ICHD) criteria;
  • Clinical indication, according to routine practice, for treatment with anti-CGRP monoclonal antibodies or gepants (only for the longitudinal subgroup);
  • Ability and willingness to provide written informed consent. Inclusion criteria for healthy controls
  • Male or female participants aged ≥ 18 years;
  • Subjects, without migraine;
  • Ability and willingness to provide written informed consent.

Exclusion criteria (for both patients with migraine and healthy controls)

  • Fulfillment of ICHD diagnostic criteria for secondary headaches;
  • Active inflammatory ocular diseases;
  • Severe abnormalities in tear production;
  • Systemic inflammatory diseases that may interfere with biomarker interpretation.

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
Healthy controls
Patients with migraine
Diagnostic test: Patients with migraine
Patients with migraine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in tear biomarker
Time Frame: Through the study completion, about 3 years
Differences in tear levels between patients with migraine and healthy controls of the following biomarkers: Calcitonin Gene-Related Peptide (CGRP), pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), Interleukin 10 (IL-10), Interleukin 1β (IL-1β), Tumor necrosis factor-α (TNF-α).
Through the study completion, about 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations between tear biomarkers and clinical features of migraine
Time Frame: Through the study completion, about 3 years
  • Correlations between tear biomarkers and clinical features of migraine;
  • Biomarker levels across different migraine phenotypes;
  • Associations with psychiatric comorbidities and fibromyalgia;
  • Concordance between tear and plasma levels; longitudinal changes of tear fluid biomarkers during treatment;
  • Predictive value for treatment response.
Through the study completion, about 3 years

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 (Estimated)

September 30, 2026

Primary Completion (Estimated)

September 29, 2029

Study Completion (Estimated)

September 29, 2029

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27643

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

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.

Clinical Trials on Migraine

Clinical Trials on Patients with migraine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe