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NCT07690696Not yet recruiting

Tear Biomarkers for Migraine

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

Source: ClinicalTrials.gov · Last updated 10 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
1 Jul 2026
Start date
30 Sept 2026
Primary completion date
29 Sept 2029
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Diseases
Migraine
NCT number
NCT07690696

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From 30 Sept 2026 to the primary completion date, 29 Sept 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Active inflammatory ocular diseases;
  • Systemic inflammatory diseases that may interfere with biomarker interpretation.

Other

  • Fulfillment of ICHD diagnostic criteria for secondary headaches;
  • Severe abnormalities in tear production;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.