A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

Eisai Limited191 enrolled

Overview

The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures \[POS\] with or without secondary generalization \[SG\] or for primary generalized tonic-clonic seizures \[PGTCS\] associated with idiopathic generalized epilepsy \[IGE\] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.

Study Type

OBSERVATIONAL

Enrollment

191

Conditions

Idiopathic Generalized Epilepsy Partial Onset Seizures Generalised Tonic-Clonic Seizures

Interventions

PerampanelDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of epilepsy 2. History of POS with or without SG or PGTCS associated with IGE 3. Documented POS with or without SG or PGTCS associated with IGE, within the past 12 months 4. Previously treated with 1 or 2 AEDs as monotherapy 5. At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate baseline seizure frequency Exclusion Criteria: 1. Episode(s) of status epilepticus within the past 6 months before Screening 2. Previously treated with 2 or more AEDs in combination (other than during cross-titration between AED monotherapies) 3. Previous or current use of perampanel Note: Retrospective inclusions will be allowed but only if the time between the initiation of perampanel treatment and the inclusion does not exceed 7 calendar days 4. Hypersensitivity to perampanel or any of the excipients

Locations (36)

Sydvestjysk Sygehus Esbjerg

Esbjerg, Region Syddanmark, Denmark

Hôpital Pontchaillou

Rennes, Ille-et-Vilaine, France

Hôpital Roger Salengro

Lille, Nord, France

Centre de consultations Saint-Jean Bâtiment A

Cagnes-sur-Mer, France

Hopitaux de La Timone

Marseille, France

Hôpital Robert Debré

Outcomes

Primary Outcomes

Retention Rate at Month 12

Retention rate at 12 months is defined as the percentage of participants remaining on perampanel at 12 months.

Time frame: Month 12

Secondary Outcomes

Retention Rate at Month 6

Retention rate at 6 months is defined as the percentage of participants remaining on perampanel at 6 months.

Time frame: Month 6

Pragmatic Seizure-free Rate at Months 6 and 12

Pragmatic seizure-free rate is defined as the percentage of participants (based on all study participants) who are free of all seizures at 6 months (and for the previous 3 months) and at 12 months (and for the previous 6 months).

Time frame: Months 6 and 12

Completer Seizure-free Rate at Months 6 and 12

Completer seizure-free rate is defined as the percentage of participants (based on a subset of study participants who remain on perampanel treatment at 6 and 12 months) who are free of all seizures at 6 months (and for the previous 3 months) and at 12 months (and for the previous 6 months), respectively.

Time frame: Months 6 and 12

Median Percent Change From Baseline in Seizure Frequency at Months 6 and 12

Seizure frequency change will be measured at 6 months (averaged over the previous 3 months) and at 12 months (averaged over the previous 6 months).

Time frame: Months 6 and 12

50 Percent (%) Responder Rate at Months 6 and 12

50% responder rate is defined as the percentage of participants with greater than or equal to (\>=) 50% reduction in seizure frequency (averaged over the 3 months before the 6-month visit, and over the 6 months before the12-month visit) relative to baseline.

Time frame: Months 6 and 12

Seizure Worsening Rate at Months 6 and 12

Seizure worsening rate is defined as the percentage of participants with \>=10% increase in seizure frequency (averaged over the 3 months before the 6-month visit, and over the 6 months before the 12-month visit) relative to baseline.

Time frame: Months 6 and 12

Last Dose of Perampanel at Months 6 and 12

Time frame: Months 6 and 12

Percentage of Participants by Perampanel Dose Titration Speed

Time frame: Up to Month 12

Duration of Treatment on Perampanel

Time frame: Up to Month 12

Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs),Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, and TEAEs by Severity

Time frame: Up to Month 12