Tear Biomarkers for Migraine
ConditionMigraine
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Patients with migraine
Treatment groups
400 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov