An observational study in Migraine, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 400 is above the median of 137 across 331 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with migraine and healthy controls
Inclusion criteria patients with migraine
Exclusion criteria (for both patients with migraine and healthy controls)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with migraine
Diagnostic Test: Patients with migraine
Healthy controls
Patients with migraine
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
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS →