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

NCT07029126 | Recruiting

• 1 other identifier: MI_DEAR
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 10

Brief Summary

To evaluate the reduction of emotional burden (measured by Relative Stress Scale-RSS) of caregivers of migraine patients with Depressive Symptoms after 6 months after the first injection of fremanezumab.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• CHANGE in caregiver stress

  Change in Relative Stress Scale (RSS) scores in caregivers (range 15-60, where 15 is no stress and 60 maximum stress)

  from baseline to evaluation at 6 months after fremanezumab therapy

Secondary Outcomes (5)

• CHANGE IN RECIPROCITY

  from baseline to the evaluation after 6 months of therapy with fremanezumab

• CORRELATION BETWEEN CHANGE IN patient depression and caregiver stress

  from baseline to 6 months after fremanezumab therapy

• CORRELATION BETWEEN THE CHANGES IN DEPRESSION AND RECIPROCITY SCALE SCORES

  from baseline to 6 months after therapy with fremanezumab

• PATIENT ANXIETY AND CAREGIVER STRESS

  from baseline to 6 months after fremanezumab therapy

• PATIENT DISABILTY AMD CAREGIVER STRESS

  from baseline to 6 months after fremanezumab therapy

Study Arms (2)

PATIENTS

Adult male or female patients with diagnosis of migraine, with or without aura, or chronic migraine, according to the International Classification of Headaches (ICHD-3.)

Drug: Fremanezumab

CAREGIVER

Adult subjects, male or female who are informal caregiver of enrolled migraine patients, 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)

Interventions

Fremanezumab DRUG

subcutaneous injection 225 mg monthly or 675 mg quarterly

PATIENTS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be composed of female and male patients aged \>18 with a diagnosis of migraine with and without aura (as defined by the International Classification of Headache Disorders, ICHD-3)15. Patients must have been diagnosed with migraine at least 12 months before the baseline visit, and the diagnosis of migraine will be confirmed via a review of the medical chart and of a 4-week headache diary before the baseline visit. Only patients with an indication to start a new preventive medication with fremanezumab and their caregivers will be enrolled.

You may qualify if:

• 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
• % 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
• % compliance with completion scale ability to provide written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (10)

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Italy, 00145, 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

MeSH Terms

Conditions

Migraine Disorders

Interventions

fremanezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Claudia Altamura, MD, PhD

CONTACT

+3906225411270; c.altamura@policilnicocampus.it

Luisa Fofi, MD

CONTACT

l.fofi@policlinicocampus.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: June 19, 2025
• Study Start: October 3, 2024
• Primary Completion: October 30, 2025
• Study Completion: March 30, 2026
• Last Updated: June 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10)