Tear Biomarkers for Migraine

NCT07690696 | Not Yet Recruiting

• 1 other identifier: 27643
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Migraine

Keywords

migraine; headache; tears; CGRP; PACAP-38; IL-10; IL-1β; TNF-α

Outcome Measures

Primary Outcomes (1)

• Differences in tear biomarker

  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 Outcomes (1)

• Correlations between tear biomarkers and clinical features of migraine

  Through the study completion, about 3 years

Study Arms (2)

Patients with migraine

Patients with migraine

Diagnostic Test: Patients with migraine

Healthy controls

Healthy controls

Interventions

Patients with migraine DIAGNOSTIC_TEST

Patients with migraine

Patients with migraine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with migraine and healthy controls

You may qualify if:

• 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);
• Male or female participants aged ≥ 18 years;
• Subjects, without migraine;
• Ability and willingness to provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Migraine Disorders; Headache; Lacerations

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Catello Vollono, MD, PhD, Neurologist

CONTACT

+393920105407; catello.vollono@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): September 29, 2029
• Study Completion (Estimated): September 29, 2029
• Last Updated: July 10, 2026

Record last verified: 2026-06