atoGepant In reaAl Life iN iTaly

Study Overview
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Brief Summary
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Atogepant is an oral, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist that has been approved for the preventive treatment of episodic and chronic migraine (>= 4 monthly migraine days) with or without medication overuse.

Detailed Description
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This study is designed to confirm the effectiveness and safety of atogepant in real life. The primary endpoint is the change from baseline in the mean number of monthly migraine days (MMDs)across the 12 weeks. Secondary endpoints include: change in monthly analgesic intake, Numeric Rating Scale (NRS), Headache Impact Test-6 (HIT-6) and Migraine disability assessment (MIDAS) scores, >=50%, >=75%, 100% responders, >=50%, >=75%, 100% responders in patients with medication overuse at weeks 9-12 compared to baseline and adverse events eventually occur during 12 weeks of treatment.

Official Title
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atoGepant In reaAl Life iN iTaly

Conditions
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Migraine, Prophylaxis

Intervention / Treatment
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* Drug: Atogepant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Consecutive patients Age: >18 yrs Migraine frequency: >=4 monthly migraine days (MMDs) Headache Centers, outpatient clinics Exclusion Criteria: Patients using concomitant migraine prophylaxis Use of onabotulinumtoxinA during the previous 12 weeks Sxposure to anti-CGRP mAbs during the previous 24 weeks Clinically significant cardiovascular disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atogepant|atogepant in real life in Italy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in monthly migraine days at weeks 9-12 compared to baseline | variation of number of monthly migraine days | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in monthly analgesic intake at weeks 9-12 compared to baseline | variation of number of analgesic intake | 12 weeks | 
| Change in Numerical Rating Scale (NRS) at weeks 9-12 compared to baseline | variation of NRS | 12 weeks | 
| Change in HIT-6 (Headache Impact Test) score at weeks 9-12 compared to baseline | variation of HIT-6 | 12 weeks | 
| Change in MIDAS score at weeks 1-12 compared to baseline Change in MIDAS (Migraine Disability Assessment Score) score at weeks 9-12 compared to baseline | variation of MIDAS | 12 weeks | 
| >50%, >75%, 100% responders at weeks 9-12 compared to baseline | proportion of migraine patients who respond to atogepant with reduction of MMDs >=50%, >=75% and 100% | 12 weeks | 
| >50%, >75%, 100% responders at weeks 9-12 compared to baseline in patients with Medication overuse | proportion of migraine patients with medication overuse who respond to atogepant with reduction of MMDs >=50%, >=75% and 100% | 12 weeks | 
| adverse events | adverse events eventually occur during 12 weeks of treatment | 12 weeks |