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Tears may hold key to migraine diagnosis and treatment tracking

NCT ID NCT07690696

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study investigates whether biomarkers in tear fluid can help diagnose migraine and monitor response to anti-CGRP therapies. Researchers will compare tear and blood samples from 400 people with migraine and healthy controls. A subgroup will be followed over time to see how biomarkers change during treatment. The goal is to develop a simple, non-invasive tool for migraine management.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple tear test to diagnose migraine and track how well treatments work.
What could go wrong
This is an observational study, not a treatment trial. The findings may not translate into a practical diagnostic tool or change clinical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with migraine and healthy controls

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Headache Lacerations migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

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