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NCT07029126 | RECRUITING | Migraine

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
Sponsor:

Campus Bio-Medico University Polyclinic Foundation

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.

Condition or disease

Migraine

Intervention/treatment

Fremanezumab

Study Type : OBSERVATIONAL
Estimated Enrollment : 300 participants
Official Title : 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
Actual Study Start Date : 2024-10-03
Estimated Primary Completion Date : 2025-10-30
Estimated Study Completion Date : 2026-03-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
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

Location Details

NCT07029126

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Italy, Italy

Campus Bio-Medico University Polyclinic Foundation

Rome, Italy, Italy, 00145

RECRUITING

Italy,

"Umberto I" United Hospitals - GM LANCISI G.SALESI

Ancona, Italy,

RECRUITING

Italy,

PO Avezzano "S. Filippo and Nicola"

Avezzano, Italy,

RECRUITING

Italy,

"L. Amaducci" Neurological Clinic Bari Polyclinic Consortium University Hospital

Bari, Italy,

RECRUITING

Italy,

IRCCS Institute of Neurological Sciences

Bologna, Italy,

RECRUITING

Italy,

ASST Spedali Civili Brescia

Brescia, Italy,

RECRUITING

Italy,

IRCCS Foundation "Carlo Besta Neurological Institute

Milan, Italy,

RECRUITING

Italy,

Department of advanced medical and surgical sciences, University of Campania "Luigi Vanvitelli

Naples, Italy,

RECRUITING

Italy,

IRCCS San Raffaele Pisana

Rome, Italy,

RECRUITING

Italy,

Fatebenefratelli-San Pietro Hospital

Rome, Italy,