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| Name | Class |
|---|---|
| Teva Pharmaceuticals USA | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.) |
| |
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fremanezumab | Drug | subcutaneous injection 225 mg monthly or 675 mg quarterly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | from baseline to evaluation at 6 months after fremanezumab therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | from baseline to the evaluation after 6 months of therapy with fremanezumab |
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Inclusion Criteria:
PATIENTS
INFORMAL CAREGIVERS:
Exclusion Criteria:
Patients:
Informal Caregivers:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Altamura, MD, PhD | Contact | +3906225411270 | c.altamura@policilnicocampus.it | |
| Luisa Fofi, MD | Contact | l.fofi@policlinicocampus.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Campus Bio-Medico | Recruiting | Rome | Italy | 00145 | Italy |
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| 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. | 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 (PHQ-9 SCALE) and anxiety (STAY SCALE) symptoms in migraine patients 6 months after starting fremanezumab is associated with the change in reciprocity (MUTUALITY SCALE) between patient and caregiver | 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 | 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 | from baseline to 6 months after fremanezumab therapy |
| Ospedali Riuniti "Umberto I"- GM LANCISI G.SALESI | Recruiting | Ancona | Italy |
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| PO Avezzano "S.Filippo e Nicola" | Recruiting | Avezzano | Italy |
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| Clinica Neurologica "L. Amaducci" Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari | Recruiting | Bari | Italy |
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| IRCCS Istituto Scienze Neurologiche | Recruiting | Bologna | Italy |
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| ASST Spedali Civili Brescia | Recruiting | Brescia | Italy |
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| Fondazione IRCCS Istituto Neurologico "Carlo Besta | Recruiting | Milan | Italy |
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| Dipartimento delle scienze avanzate mediche e chirurgiche, Università della Campania "Luigi Vanvitelli | Recruiting | Naples | Italy |
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| IRCCS San Raffaele Pisana | Recruiting | Rome | Italy |
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| Ospedale Fabenefratelli- San Pietro | Recruiting | Rome | Italy |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000604315 | fremanezumab |
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