Could a migraine injection also heal caregiver burnout?
NCT ID NCT07029126
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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308 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Mar 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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ASST Spedali Civili Brescia
Brescia, Italy
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Clinica Neurologica "L. Amaducci" Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Bari, Italy
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Dipartimento delle scienze avanzate mediche e chirurgiche, Università della Campania "Luigi Vanvitelli
Naples, Italy
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Fondazione IRCCS Istituto Neurologico "Carlo Besta
Milan, Italy
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Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Italy, 00145, Italy
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IRCCS Istituto Scienze Neurologiche
Bologna, Italy
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IRCCS San Raffaele Pisana
Rome, Italy
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Ospedale Fabenefratelli- San Pietro
Rome, Italy
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Ospedali Riuniti "Umberto I"- GM LANCISI G.SALESI
Ancona, Italy
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PO Avezzano "S.Filippo e Nicola"
Avezzano, Italy
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