Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)

Study Overview
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Brief Summary
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Perampanel is a non-competitive antagonist of the AMPA ( 2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved by the European Medicines Agency as adjunctive treatment for partial-onset seizures in patients 12 years and older, in 2012. The aim of this study is to evaluate effectiveness and safety of perampanel as add-on treatment in patients with refractory epilepsy. The investigators retrospectively collected and analyzed the data of patients with refractory epilepsy who had been treated with perampanel between May of 2014 and April of 2015. In total, one hundred and ten patients were included (mean age 41 [SD = 15.2]). The mean duration of epilepsy was 25 years (SD = 14.4). The mean perampanel dose was 5.7 mg/d (SD = 2.3). The retention rate was 77% at 6 months and 61% at 12 months. After 6 months, the responder rate was 35.5%. Eight patients (7.3%) became seizure free. Adverse effects were reported in 60 patients (54.5%). Most common side effects were behaviour disturbance (22.7%), dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1).

Official Title
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Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)

Conditions
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Refractory Epilepsy

Intervention / Treatment
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* Drug: Perampanel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with refractory focal epilepsy Initiation of perampanel between 05/2014 and 04/2015 Exclusion Criteria: Exact date of initiation of Perampanel not defined Patients without follow-up data

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 86 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 |
| --- | --- |
| patients treated with Perampanel<br> | Drug: Perampanel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rate | Proportion of patient still treated with Perampanel 6 months after its initiation | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rate | Proportion of patients still treated with Perampanel 12 months after its initiation | 12 months | 
| Seizure freedom | Proportion of seizure-free patients during at least 6 months | 6 months | 
| Responder rates | Responder rates is defined as a reduction in seizure frequency of 50% or more compared with the three months before the initiation of perampanel. | 6 months | 
| Responder rates | Responder rates is defined as a reduction in seizure frequency of 50% or more compared with the three months before the initiation of perampanel. | 12 months | 
| Total withdrawal rate | Discontinuation rates at 6 months due to inefficiency or adverse effects | 6 months | 
| Total withdrawal rate | Discontinuation rates at 12 months due to inefficiency or adverse effects | 12 months | 
| Observed adverse effects during the observation period |  | 12 months |