A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

Study Overview
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Brief Summary
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The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures [POS] with or without secondary generalization [SG] or for primary generalized tonic-clonic seizures [PGTCS] associated with idiopathic generalized epilepsy [IGE] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.

Official Title
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A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Adjunctive Therapy in the Routine Clinical Care of Subjects >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

Conditions
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Idiopathic Generalized Epilepsy, Partial Onset Seizures, Generalised Tonic-Clonic Seizures

Intervention / Treatment
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* Drug: Perampanel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of epilepsy History of POS with or without SG or PGTCS associated with IGE Documented POS with or without SG or PGTCS associated with IGE, within the past 12 months Previously treated with 1 or 2 AEDs as monotherapy At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate baseline seizure frequency Exclusion Criteria: Episode(s) of status epilepticus within the past 6 months before Screening Previously treated with 2 or more AEDs in combination (other than during cross-titration between AED monotherapies) Previous or current use of perampanel Note: Retrospective inclusions will be allowed but only if the time between the initiation of perampanel treatment and the inclusion does not exceed 7 calendar days Hypersensitivity to perampanel or any of the excipients

Ages Eligible for Study
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Minimum Age: 12 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perampanel<br>Participants with a diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE) will initiate treatment with perampanel as first adjunctive treatment as per the clinical judgment of the treating physician as part of routine clinical care. All participants will be observed prospectively for up to 12 months after initiation of perampanel treatment. | Drug: Perampanel<br>* Perampanel oral tablets or oral suspension.<br>* Other names: Fycompa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention Rate at Month 12 | Retention rate at 12 months is defined as the percentage of participants remaining on perampanel at 12 months. | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention Rate at Month 6 | Retention rate at 6 months is defined as the percentage of participants remaining on perampanel at 6 months. | Month 6 | 
| Pragmatic Seizure-free Rate at Months 6 and 12 | Pragmatic seizure-free rate is defined as the percentage of participants (based on all study participants) who are free of all seizures at 6 months (and for the previous 3 months) and at 12 months (and for the previous 6 months). | Months 6 and 12 | 
| Completer Seizure-free Rate at Months 6 and 12 | Completer seizure-free rate is defined as the percentage of participants (based on a subset of study participants who remain on perampanel treatment at 6 and 12 months) who are free of all seizures at 6 months (and for the previous 3 months) and at 12 months (and for the previous 6 months), respectively. | Months 6 and 12 | 
| Median Percent Change From Baseline in Seizure Frequency at Months 6 and 12 | Seizure frequency change will be measured at 6 months (averaged over the previous 3 months) and at 12 months (averaged over the previous 6 months). | Months 6 and 12 | 
| 50 Percent (%) Responder Rate at Months 6 and 12 | 50% responder rate is defined as the percentage of participants with greater than or equal to (>=) 50% reduction in seizure frequency (averaged over the 3 months before the 6-month visit, and over the 6 months before the12-month visit) relative to baseline. | Months 6 and 12 | 
| Seizure Worsening Rate at Months 6 and 12 | Seizure worsening rate is defined as the percentage of participants with >=10% increase in seizure frequency (averaged over the 3 months before the 6-month visit, and over the 6 months before the 12-month visit) relative to baseline. | Months 6 and 12 | 
| Last Dose of Perampanel at Months 6 and 12 |  | Months 6 and 12 | 
| Percentage of Participants by Perampanel Dose Titration Speed |  | Up to Month 12 | 
| Duration of Treatment on Perampanel |  | Up to Month 12 | 
| Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs),Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, and TEAEs by Severity |  | Up to Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perampanel, Fycompa, Epilepsy, Seizures, Prospective