MigraineNCT07029126
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
An observational study of Migraine, run by Fondazione Policlinico Universitario Campus Bio-Medico at 10 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Fremanezumab
- Type of treatment
- Injection or infusion
- How many people
- 308 participants
- Where
- 10 sitesItaly
- Study dates
- 3 Oct 2024to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Ospedali Riuniti "Umberto I"- GM LANCISI G.SALESI
Ancona
PO Avezzano "S.Filippo e Nicola"
Avezzano
Clinica Neurologica "L. Amaducci" Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Bari
IRCCS Istituto Scienze Neurologiche
Bologna
ASST Spedali Civili Brescia
Brescia
Fondazione IRCCS Istituto Neurologico "Carlo Besta
Milan
Dipartimento delle scienze avanzate mediche e chirurgiche, Università della Campania "Luigi Vanvitelli
Naples
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Italy, 00145
IRCCS San Raffaele Pisana
Rome
Ospedale Fabenefratelli- San Pietro
Rome
About this study
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
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
- Being tested
- Fremanezumab
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FremanezumabDrug
subcutaneous injection 225 mg monthly or 675 mg quarterly
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: from baseline to evaluation at 6 months of fremanezumab therapy
Secondary outcomes (5)
CHANGE IN RECIPROCITY
To evaluate an increase in reciprocity within the mutuality scale in the caregiver/ migraine patient dyad after 6 months from the first injection of fremanezumab.
Reciprocity represents the mean value of the response to questions 5, 6, 10, 13, and 15 of the mutuality scale (raging from 0, lower reciprocity, to 4 higher reciprocity)
Measured: from baseline to the evaluation at 6 months of therapy with fremanezumab
CORRELATION BETWEEN CHANGE IN patient depression and caregiver stress
to evaluate whether the change in depression (Patient Health Questionnaire. PHQ-9 scores, range 0-27; higher scores indicate more severe depression) in migraine patients 6 months after starting fremanezumab is associated with the change of stress (Relative Stress Scale) in caregivers.
Measured: from baseline to 6 months after fremanezumab therapy
CORRELATION BETWEEN THE CHANGES IN DEPRESSION AND RECIPROCITY SCALE SCORES
To evaluate whether the CHANGE in depressive (Patient Health Questionnaire. PHQ-9 scores, range 0-27; higher scores indicate more severe depression) and anxiety (STATE-TRAIT ANXIETY INVENTORY STAY, range 20-80, from 40 points to higher scores indicate anxiety) symptoms in migraine patients 6 months after starting fremanezumab is associated with the change in reciprocity (MUTUALITY SCALE, range 0-4 higher score inficate higher mutuality) between patient and caregiver
Measured: from baseline to 6 months after therapy with fremanezumab
PATIENT ANXIETY AND CAREGIVER STRESS
to evaluate whether the change in anxiety (STATE-TRAIT ANXIETY INVENTORY STAY, range 20-80, from 40 points to higher scores indicate anxiety) symptoms in migraine patients 6 months after starting fremanezumab is associated with the change of stress (Relative Stress Scale) in caregivers
Measured: from baseline to 6 months after fremanezumab therapy
PATIENT DISABILTY AMD CAREGIVER STRESS
to evaluate whether the change in anxiety disability (MiGRAINE DISABILITY ASSESSMENT MIDAS raging from 0 to 270, higher scores indicate greater disability) in migraine patients 6 months after starting fremanezumab is associated with the change of stress (Relative Stress Scale) in caregivers
Measured: from baseline to 6 months after fremanezumab therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start3 Oct 2024
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029126
- Sponsor's protocol ID
- MI_DEAR
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07029126
- Acronym / sponsor ID
- MI_DEAR
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATIENTS | – | Drug: FremanezumabAdult male or female patients with diagnosis of migraine, with or without aura, or chronic migraine, according to the International Classification of Headaches (ICHD-3.) |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fremanezumabsubcutaneous injection 225 mg monthly or 675 mg quarterly | Drug | PATIENTS |
Primary outcome
CHANGE in caregiver stress
Time frame: from baseline to evaluation at 6 months of fremanezumab therapy
Change in Relative Stress Scale (RSS) scores in caregivers (range 15-60, where 15 is no stress and 60 maximum stress)
5 secondary outcomes
CHANGE IN RECIPROCITY
Time frame: from baseline to the evaluation at 6 months of therapy with fremanezumab
CORRELATION BETWEEN CHANGE IN patient depression and caregiver stress
Time frame: from baseline to 6 months after fremanezumab therapy
CORRELATION BETWEEN THE CHANGES IN DEPRESSION AND RECIPROCITY SCALE SCORES
Time frame: from baseline to 6 months after therapy with fremanezumab
PATIENT ANXIETY AND CAREGIVER STRESS
Time frame: from baseline to 6 months after fremanezumab therapy
PATIENT DISABILTY AMD CAREGIVER STRESS
Time frame: from baseline to 6 months after fremanezumab therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Fondazione Policlinico Universitario Campus Bio-Medico at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CHANGE in caregiver stress (time frame: from baseline to evaluation at 6 months of fremanezumab therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.