A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.

Detailed Description
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This is a global, observational, cohort study in patients with epilepsy. Multiple treating physicians will prescribe perampanel to approximately 500 patients, who then will be observed for approximately 52 weeks.

Official Title
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A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Perampanel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male or female patients age greater than or equal to 12 years (or as regionally appropriate) at the time of informed consent Patients prescribed perampanel for the adjunctive treatment of epilepsy within 7 days of the Screening Visit Patients who provide informed consent Exclusion Criteria Participation in another study involving administration of an investigational drug or device whilst participating in this observational study Prior participation in a perampanel clinical study Hypersensitivity to perampanel

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>Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment | Drug: Perampanel<br>* Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatment Emergent Adverse Events (TEAEs) of interest | Assessment of events of dizziness, blurred vision, somnolence, aggression, balance disorders, ataxia, falls, unintended pregnancy, weight gain, suicidality, drug abuse, misuse, dependence, withdrawal, off-label use, skin photosensitivity, unintended pregnancy while taking levonorgestrel-containing contraceptives, and outcomes associated with any suspected drug-drug interaction. | Up to 52 weeks and 2 weeks of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of unintended pregnancy |  | Up to 52 weeks | 
| Incidence of off-label use |  | Up to 52 weeks | 
| Summary scores for the Hospital Anxiety and Depression Scale (HADS) |  | Screening, Week 52 | 
| Number of TEAEs in the patient subpopulations of interest | TEAEs observed in the specified subpopulations of patients could also be made in order to get a better understanding of whether any of these particular potential risk factors (e.g., old age, cardiovascular disease) define groups with greater or lesser risk. | Up to 52 weeks and 2 weeks of follow-up | 
| Clinical Global Impression of Change | Assessment of disease severity will utilize the Clinical Global Impression of Change (CGI-C) scale at end of treatment to evaluate change in disease status since initiation of treatment. | Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy