Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Patients With Epilepsy

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the retention rate of perampanel when given as secondary monotherapy in routine clinical care.

Detailed Description
-----------------
This study is a retrospective study of participants who received perampanel as primary or secondary monotherapy at approximately 40 centers in Europe, Asia, and Australia. Primary monotherapy is defined as the administration of perampanel in the absence of any concomitant antiepileptic drugs (AEDs). Secondary (conversion) monotherapy is defined as the conversion of perampanel from adjunctive therapy to monotherapy by withdrawing concomitant AEDs.

Official Title
-----------------
A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Routine Clinical Care in Patients With Epilepsy

Conditions
-----------------
Epilepsy, Partial-Onset Seizures, Primary Generalized Tonic-Clonic Seizures

Intervention / Treatment
-----------------
* Other: No treatment (intervention) was administered


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of epilepsy Received perampanel as primary or secondary monotherapy at any time between 1 Jan 2013 and 15 Oct 2015 Provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records per local requirements Exclusion Criteria: Not applicable
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perampanel<br>Participants with a diagnosis of epilepsy who received perampanel as primary or secondary (conversion) monotherapy at any time between 1 Jan 2013 and 15 Oct 2015. | Other: No treatment (intervention) was administered<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rate | The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy | Month 3 | 
| Retention rate | The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy | Month 6 | 
| Retention rate | The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy | Month 12 | 
| Retention rate | The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy | Month 18 | 
| Retention rate | The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy | Month 24 | 
| Participants remaining on perampanel monotherapy (after conversion from perampanel as adjunctive therapy) |  | Up to approximately 34 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants receiving perampanel monotherapy out of the total number of participants prescribed perampanel |  | Up to approximately 34 months | 
| Percentage of participants with greater than or equal to 50% reduction in seizure frequency |  | Up to approximately 34 months | 
| Percentage of participants who were seizure-free for at least 3 months | Seizure-free is defined as a terminal remission of seizures | Up to approximately 34 months | 
| Percentage of participants with greater than or equal to 75% reduction in seizure frequency |  | Up to approximately 34 months | 
| Percentage of participants with categorized percent reductions in seizure frequency |  | Up to approximately 34 months | 
| Percentage of participants with no change or worsening of seizures |  | Up to approximately 34 months | 
| Median percent change in seizure frequency |  | Up to approximately 34 months | 
| Percentage of participants with treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs) |  | Up to approximately 34 months | 
| Mean change in body weight |  | Up to approximately 34 months | 
| Maximum dose of perampanel during adjunctive therapy and monotherapy |  | Up to approximately 34 months | 
| Average dose of perampanel during adjunctive therapy and monotherapy |  | Up to approximately 34 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perampanel, E2007, Phase 4, Fycompa