Fremanezumab for migraine and its effect on caregiver stress and couple reciprocity

Improving the Perception of Stress and Mutuality in Caregivers (MI-DEAR Study) of Migraine Patients With Depressive Symptoms Treated With Fremanezumab: A Prospective Real-life Observational Study to Evaluate Whether Fremanezumab Reduces the Impact on Caregivers and Increases Couple Reciprocity

This trial tests whether giving fremanezumab to adults with migraine and depressive symptoms reduces emotional burden on their informal caregivers and improves couple reciprocity over six months.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico (Academic / other)
• Drugs / interventions: fremanezumab
• Locations: 10 sites (Rome, Italy and 9 other locations)
• Trial ID: NCT07029126 on ClinicalTrials.gov

What this trial studies

This is an observational follow-up of adults with migraine and depressive symptoms who begin fremanezumab treatment, tracking outcomes for their informal caregivers over six months after the first injection. Caregiver emotional burden will be measured primarily by the Relative Stress Scale (RSS) and couple reciprocity measures. Eligible patients must meet ICHD-3 migraine criteria, have PHQ-9 ≥5, be naive to CGRP-targeting monoclonal antibodies, and have a spouse acting as an informal caregiver; concomitant antidepressants must be stable for at least 8 weeks. The study is conducted at several Italian university hospitals and collects migraine diaries and standard clinical data without randomization or blinding.

Who should consider this trial

Good fit: Adult migraine patients (onset <50 years) with PHQ-9 ≥5 who are starting fremanezumab as their first CGRP-pathway monoclonal antibody and who have an adult informal caregiver (spouse) and can comply with diary and scale completion are ideal candidates.

Not a fit: Patients without depressive symptoms (PHQ-9 <5), those already treated with CGRP monoclonal antibodies, patients without an informal caregiver, or those unable to comply with diary requirements may not receive benefit from this observational protocol.

Why it matters

Potential benefit: If successful, this could reduce caregiver emotional burden and improve couple reciprocity, potentially strengthening support for patients and enhancing quality of life for both partners.

How similar studies have performed: Fremanezumab and other CGRP-targeting antibodies have demonstrated effectiveness in preventing migraine, but using these treatments specifically to reduce caregiver stress and increase couple reciprocity is a novel focus with limited prior evidence.

Eligibility criteria

Inclusion Criteria:

PATIENTS

* Adult patients, male or female
* Diagnosis of migraine, with or without aura, or chronic migraine, according to the International Classification of Headaches (ICHD-3.)
* Diagnosis of migraine with onset at an age of less than 50 years
* Depressive symptoms in patients defined as a Patient Health Questionnaire PHQ-9 scale score ≥5
* Complete details of migraine history and frequency of monthly migraine days in the past month
* clinical indication to start fremanezumab therapy to prevent migraine in patients naïve to monoclonal antibodies targeting the CGRP pathway
* In case of migraine preventive therapy and concomitant antidepressants, stability for at least 8 weeks prior to enrollment.
* Presence of a caregiver (see definition below) of the patient
* 80% compliance with diary and ability to complete the scale to provide written informed consent.

INFORMAL CAREGIVERS:

* Adult subjects, male or female.
* Informal caregiver is defined as a person--spouse/partner, parent, child/child, sibling--who cares for the migraine patient, sharing the same household and performing various functions, from basic daily needs to socio-economic activities)
* RSS score ≥ 1
* 80% compliance with completion scale ability to provide written informed consent

Exclusion Criteria:

Patients:

* Patients without a caregiver
* Contraindications or lack of indication to fremanezumab
* The patient has clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, ocular disease, or complications of an infection, at the discretion of the investigator
* Patient with a clinical history of a severe or uncontrolled psychiatric disorder (bipolar disorders, schizophrenia, psychosis), at the discretion of the investigator, that would likely interfere with full participation in the study
* Patient participating in another study at the same time as enrollment in the current study

Informal Caregivers:

* History of migraine.
* History of major depressive disorder and severe or uncontrolled psychiatric disorder (bipolar disorders, schizophrenia, psychosis), at the discretion of the investigator, that would likely interfere with full participation in the study
* The caregiver has clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, ocular disease, or complications of an infection at the discretion of the investigator.

Where this trial is running

Rome, Italy and 9 other locations

• Fondazione Policlinico Universitario Campus Bio-Medico — Rome, Italy, Italy (Recruiting)
• Ospedali Riuniti "Umberto I"- GM LANCISI G.SALESI — Ancona, Italy (Recruiting)
• PO Avezzano "S.Filippo e Nicola" — Avezzano, Italy (Recruiting)
• Clinica Neurologica "L. Amaducci" Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari — Bari, Italy (Recruiting)
• IRCCS Istituto Scienze Neurologiche — Bologna, Italy (Recruiting)
• ASST Spedali Civili Brescia — Brescia, Italy (Recruiting)
• Fondazione IRCCS Istituto Neurologico "Carlo Besta — Milan, Italy (Recruiting)
• Dipartimento delle scienze avanzate mediche e chirurgiche, Università della Campania "Luigi Vanvitelli — Naples, Italy (Recruiting)
• IRCCS San Raffaele Pisana — Rome, Italy (Recruiting)
• Ospedale Fabenefratelli- San Pietro — Rome, Italy (Recruiting)

Study contacts

• Study coordinator: Claudia Altamura, MD, PhD

Conditions Migraine