Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy

Study Overview
=================
Brief Summary
-----------------
This study is conducted to assess the retention rate of Fycompa when given in routine clinical care.

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

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Fycompa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must have met all of the following criteria to be included in this study: Diagnosis of epilepsy Initiated treatment with Fycompa at any time after 01 Jan 2014 Provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records (if required by an Institutional Review Board [IRB] or Independent Ethics Committee [IEC], or by regulatory authorities). 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 |
| --- | --- |
| Fycompa<br>Participants diagnosed with epilepsy and treated with Fycompa | Drug: Fycompa<br>* Oral suspension<br>* Other names: Perampanel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants remaining on Fycompa treatment at specified time points after initiation of treatment (Retention rate) | Retention rate is the ratio of the number of participants remaining on Fycompa treatment to the number of participants who could have been exposed for that length of time. | 3, 6, 12, 18, and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a 50% response rate | The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used. | up to 24 months | 
| Number of participants with a 75% response rate | The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used. | up to 24 months | 
| Number of participants with a 100% response rate | The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used. | up to 24 months | 
| Categorized percent reduction in seizure frequency from baseline | An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure). | Baseline, up to 24 months | 
| Median percent change in seizure frequency from baseline | An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure). | Baseline, up to 24 months | 
| Percentage of participants who had no change or a worsening of seizures from baseline | An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure). | Baseline, up to 24 months | 
| Total provider health care visits before, during, and after final dose of Fycompa | Total provider health care visits before, during, and after final dose of Fycompa will be summarized as a safety variable. | 6 months before initiation of Fycompa to 6 months after last dose of Fycompa | 
| Number of participants with any treatment-emergent (TE) serious adverse event (SAE) resulting in discontinuation of Fycompa | An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening (ie, the participant was at immediate risk of death from the adverse events [AE] as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. | Up to 24 months | 
| Number of participants with any treatment-emergent adverse event (TEAE) resulting in discontinuation of Fycompa | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. | Up to 24 months | 
| Mean change in body weight from baseline | Change from baseline is calculated as the post-baseline value minus the baseline value. | Baseline, Up to 24 months | 
| Mean change in height of pediatric participants from baseline | Change from baseline is calculated as the post-baseline value minus the baseline value. | Baseline, Up to 24 months | 
| Maximum dose of Fycompa | The extent of exposure of Fycompa will be determined by summarizing the maximum dose of the study drug. | Up to 24 months | 
| Average dose of Fycompa | The extent of exposure of Fycompa will be determined by summarizing the average dose of the study drug. | Up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
seizure, Fycompa