Tear Biomarkers for Migraine

N/ANot Yet RecruitingNCT07690696

Fondazione Policlinico Universitario Agostino Gemelli IRCCS400 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

400

Conditions

Migraine

Interventions

Patients with migraineDIAGNOSTIC_TEST

Patients with migraine

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Through the study completion, about 3 years

Secondary Outcomes

Correlations between tear biomarkers and clinical features of migraine

* 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.

Time frame: Through the study completion, about 3 years

Central Contacts

Catello Vollono, MD, PhD, Neurologist

CONTACT

+393920105407 catello.vollono@policlinicogemelli.it

Data from ClinicalTrials.gov

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