MigraineTEARNCT07690696
Tear Biomarkers for Migraine
An observational study of Migraine, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Patients with migraine
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 29 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with migraine and healthy controls
Who may be able to join
- 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;
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Novel Diagnostic and Treatment Response Biomarkers in Tear Fluid of Migraine Patients
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.
- Conditions
- Migraine
- Being tested
- Patients with migraine
- Keywords
- migraine, headache, tears, CGRP, PACAP-38, IL-10, IL-1β, TNF-α
- Medical subject headings
- Migraine Disorders, Headache, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with migraineDiagnostic test
Patients with migraine
| Study group | Role | What they receive |
|---|---|---|
| Patients with migraine | Patients with migraine Receives: Diagnostic Test: Patients with migraine | |
| Healthy controls | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through the study completion, about 3 years
Secondary outcomes (1)
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.
Measured: Through the study completion, about 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion29 Sep 2029 (estimated)
- Study completion29 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vollono Catello, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690696
- Sponsor's protocol ID
- 27643
- Acronym
- TEAR
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Diagnostic and Treatment Response Biomarkers in Tear Fluid of Migraine Patients
- ClinicalTrials.gov ID
- NCT07690696
- Acronym / sponsor ID
- TEAR / 27643
- Conditions
- Migraine
- Keywords
- migraine, headache, tears, CGRP, PACAP-38, IL-10, IL-1β, TNF-α
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 29 Sep 2029 (estimated)
- Study completion
- 29 Sep 2029 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with migraine | – | Diagnostic Test: Patients with migrainePatients with migraine |
| Healthy controls | – | –Healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with migraine and healthy controls
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with migrainePatients with migraine | Diagnostic test | Patients with migraine |
Primary outcome
Differences in tear biomarker
Time frame: Through the study completion, about 3 years
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).
1 secondary outcome
Correlations between tear biomarkers and clinical features of migraine
Time frame: Through the study completion, about 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Migraine
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
Migraine
Active, not recruitingObservational study
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Migraine
RecruitingObservational study
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
Migraine
RecruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catello Vollono, MD, PhD, Neurologist (+393920105407, catello.vollono@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in tear biomarker (time frame: Through the study completion, about 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.