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

Fondazione Policlinico Universitario Campus Bio-Medico

Status: Enrolling

Conditions: Migraine

Treatments: Drug: Fremanezumab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07029126

MI_DEAR

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

PATIENTS

Description:

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.)

Treatment:

Drug: Fremanezumab

CAREGIVER

Description:

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)