Tear Biomarkers for Migraine

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Lacerations Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Patients with migraine

Diagnostic Test

Patients with migraine

Primary outcomes

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).

Secondary outcomes

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.

Study contacts

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

Catello Vollono, MD, PhD, Neurologist

CONTACT

[email protected]

+393920105407

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: TEAR

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Jul 8, 2026
Registry last updated: Jul 10, 2026

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.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting