Could a migraine injection also heal caregiver burnout?

NCT ID NCT07029126

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This study looks at whether fremanezumab, a migraine prevention drug, can reduce the emotional burden on caregivers of people with migraine and depressive symptoms. Researchers will measure caregiver stress and the quality of the couple's relationship before and after six months of treatment. The study includes 308 adults with migraine and their caregivers. The goal is to see if treating the migraine patient also improves the wellbeing of the person who cares for them.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fremanezumab, a drug given by injection under the skin to prevent migraine
What this could lead to
If it works, this could show that treating migraine with depressive symptoms also lightens the emotional load on caregivers and strengthens couple relationships.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may vary, and the drug's effect on caregivers is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

308 people

The number who actually took part.

Started

Oct 2024

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • ASST Spedali Civili Brescia

    Brescia, Italy

  • Clinica Neurologica "L. Amaducci" Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

    Bari, Italy

  • Dipartimento delle scienze avanzate mediche e chirurgiche, Università della Campania "Luigi Vanvitelli

    Naples, Italy

  • Fondazione IRCCS Istituto Neurologico "Carlo Besta

    Milan, Italy

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Rome, Italy, 00145, Italy

  • IRCCS Istituto Scienze Neurologiche

    Bologna, Italy

  • IRCCS San Raffaele Pisana

    Rome, Italy

  • Ospedale Fabenefratelli- San Pietro

    Rome, Italy

  • Ospedali Riuniti "Umberto I"- GM LANCISI G.SALESI

    Ancona, Italy

  • PO Avezzano "S.Filippo e Nicola"

    Avezzano, Italy

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