Tear Biomarkers for Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients with migraine.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Novel Diagnostic and Treatment Response Biomarkers in Tear Fluid of Migraine Patients
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.
Interventions
- Diagnostic test Patients with migraine
Patients with migraine
Primary outcome measures
- Differences in tear biomarker [Time frame: Through the study completion, about 3 years]
Secondary outcome measures (1)
- Correlations between tear biomarkers and clinical features of migraine [Time frame: Through the study completion, about 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07690696 · 27643