Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures

Study Overview
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Brief Summary
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The objective of this study is to identify the following in adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa: unknown adverse drug reactions (ADRs); occurrence of ADRs; factors that are likely to affect safety and efficacy; occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items; occurrence of psychiatric adverse events as priority investigation items (eg, aggression).

Official Title
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Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures

Conditions
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Partial Seizures (With or Without Secondary Generalized Seizures), Primary Generalized Tonic-clonic Seizures

Intervention / Treatment
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* Drug: Fycompa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Epilepsy participants from 12 to 17 years of age with: Partial seizures (with or without secondary generalized seizures) Primary generalized Tonic-clonic seizures Exclusion Criteria: Participants previously treated with Fycompa

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 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 |
| --- | --- |
| Fycompa-treated epilepsy participants<br>Adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa | Drug: Fycompa<br>* The usual oral dosage for adults and children 12 years of age or older is initially 2 milligrams (mg) once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 1 week or longer. The maintenance dose is 8 mg once daily in the absence of concomitant antiepileptic drugs that accelerate the metabolism of this product, or 8 to 12 mg once daily in the presence of such concomitant drugs. The dosage may be increased or decreased as necessary by 2 mg at intervals of 1 week or longer depending on symptoms, but the maximum daily dose should not be over 12 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with any serious adverse event |  | from 0 to 104 weeks | 
| Number of participants with any non-serious adverse event |  | from 0 to 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing seizures |  | from 0 to 104 weeks | 
| Overall improvement rating in seizure frequency |  | from 0 to 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescent epilepsy participants, partial seizures, primary generalized Tonic-clonic seizures