A Phase 4, multicenter, prospective, non-interventional, observational study to investigate the effectiveness and safety/tolerability of perampanel when used as first adjunctive therapy in routine clinical practice in people with epilepsy: Study 512
IntroductionStudy 512 aimed to assess the efficacy and safety of perampanel (PER) as the first add-on therapy.MethodsIn this 12-month, prospective, observational, multicenter study, people with epilepsy (PWE) aged ≥12 years with focal-onset seizures or generalized tonic–clonic seizures (GTCS) associ...
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Frontiers Media S.A.
2025-04-01
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| author | Sergey Burd Sergey Burd Giovanni Assenza Giovanni Assenza Sofia Quintas Francisco José Gil López Jan Wagner Anna Lebedeva Anna Lebedeva Pavel Vlasov Nina Pantina Anna Patten Samantha Goldman Ricardo Sáinz-Fuertes Marta Torres Arlandis Stanislas Lagarde Stanislas Lagarde Tobias Sejbaek Tobias Sejbaek Vadim Kharkovsky |
| author_facet | Sergey Burd Sergey Burd Giovanni Assenza Giovanni Assenza Sofia Quintas Francisco José Gil López Jan Wagner Anna Lebedeva Anna Lebedeva Pavel Vlasov Nina Pantina Anna Patten Samantha Goldman Ricardo Sáinz-Fuertes Marta Torres Arlandis Stanislas Lagarde Stanislas Lagarde Tobias Sejbaek Tobias Sejbaek Vadim Kharkovsky |
| author_sort | Sergey Burd |
| collection | DOAJ |
| description | IntroductionStudy 512 aimed to assess the efficacy and safety of perampanel (PER) as the first add-on therapy.MethodsIn this 12-month, prospective, observational, multicenter study, people with epilepsy (PWE) aged ≥12 years with focal-onset seizures or generalized tonic–clonic seizures (GTCS) associated with idiopathic generalized epilepsy received PER as the first add-on therapy to antiseizure medication (ASM) monotherapy. The primary efficacy endpoint was the retention rate at 12 months. Other endpoints included change in seizure frequency from baseline; pragmatic seizure freedom rate (proportion of PWE in the full analysis set achieving freedom from all seizures); responder rate (≥50% seizure frequency reduction from baseline), changes from baseline in the 10-item Quality of Life in Epilepsy questionnaire (QOLIE-10) total score, the Epworth Sleepiness Scale (ESS), and the age-corrected EpiTrack and EpiTrack Junior total score; safety/tolerability (treatment-emergent adverse events [TEAEs]); and PER dose.ResultsOf 184 PWE (Safety Set, n = 182; Full Analysis Set, n = 174), 135 (73.4%) completed the 12-month study. The mean PER dose was 4.7 mg/day. Retention rate at 12 months was 74.2% in the overall population, 81.8% in the 12 to <18 years age group, 74.3% in the 18 to <65 years age group, and 66.7% in the ≥65 years age group. Retention rates were similar between PWE with focal-onset seizures (74.5%) and GTCS (75.0%). The median reduction in monthly seizure frequency per 28 days from baseline to 12 months was 78.6% in the overall population, 92.3% in the 12 to <18 age group, 75.0% in the 18 to <65 years age group, and 87.5% in the ≥65 years age group. In the overall population, pragmatic seizure freedom rates at 12 months were 36.2% (all seizures), 34.1% (all focal seizures), and 45.5% (GTCS); the responder rate at 12 months was 64.4% in the overall population. In total, 52.7% of PWE experienced TEAEs, and 12.1% discontinued due to TEAEs. No significant changes were identified from baseline to 12 months in QOLIE-10, ESS, and the age-corrected EpiTrack and EpiTrack Junior scores.ConclusionPER was efficacious for focal and generalized seizures across all age groups and was generally well-tolerated, as demonstrated by the high retention rates at 12 months. |
| format | Article |
| id | doaj-art-3fbb2b44839c482eb4cae2b704ae88d3 |
| institution | OA Journals |
| issn | 1664-2295 |
| language | English |
| publishDate | 2025-04-01 |
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| series | Frontiers in Neurology |
| spelling | doaj-art-3fbb2b44839c482eb4cae2b704ae88d32025-08-20T02:16:10ZengFrontiers Media S.A.Frontiers in Neurology1664-22952025-04-011610.3389/fneur.2025.15337671533767A Phase 4, multicenter, prospective, non-interventional, observational study to investigate the effectiveness and safety/tolerability of perampanel when used as first adjunctive therapy in routine clinical practice in people with epilepsy: Study 512Sergey Burd0Sergey Burd1Giovanni Assenza2Giovanni Assenza3Sofia Quintas4Francisco José Gil López5Jan Wagner6Anna Lebedeva7Anna Lebedeva8Pavel Vlasov9Nina Pantina10Anna Patten11Samantha Goldman12Ricardo Sáinz-Fuertes13Marta Torres Arlandis14Stanislas Lagarde15Stanislas Lagarde16Tobias Sejbaek17Tobias Sejbaek18Vadim Kharkovsky19Pirogov Russian National Research Medical University, Moscow, RussiaFederal Center of Brain Research and Neurotechnologies, Moscow, RussiaUOC Neurologia, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, ItalyResearch Unit of Neurology, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Rome, ItalyCentro Hospitalar Universitário Lisboa Norte, Lisbon, PortugalHospital Universitari del Sagrat Cor, Barcelona, SpainUniversity of Ulm and Universitäts-und RehabilitationsklinikenUlm, Ulm, GermanyPirogov Russian National Research Medical University, Moscow, RussiaFederal Center of Brain Research and Neurotechnologies, Moscow, RussiaDepartment of Neurology, Scientific Research Institute of Clinical Medicine named after N.A. Semashko, Russian University of Medicine, Moscow, RussiaFederal Center of Brain Research and Neurotechnologies, Moscow, RussiaEisai Europe Ltd., Hatfield, Hertfordshire, United KingdomEisai Europe Ltd., Hatfield, Hertfordshire, United KingdomEisai Europe Ltd., Hatfield, Hertfordshire, United KingdomEisai Europe Ltd., Hatfield, Hertfordshire, United Kingdom0APHM, Timone Hospital, Epileptology and Cerebral Rhythmology, Marseille, France1Aix Marseille Univ, INSERM, INS, Inst Neurosci Syst, Marseille, France2Hospital Southwest Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark3University of Southern Denmark, Odense, DenmarkDepartment of Neurology, Scientific Research Institute of Clinical Medicine named after N.A. Semashko, Russian University of Medicine, Moscow, RussiaIntroductionStudy 512 aimed to assess the efficacy and safety of perampanel (PER) as the first add-on therapy.MethodsIn this 12-month, prospective, observational, multicenter study, people with epilepsy (PWE) aged ≥12 years with focal-onset seizures or generalized tonic–clonic seizures (GTCS) associated with idiopathic generalized epilepsy received PER as the first add-on therapy to antiseizure medication (ASM) monotherapy. The primary efficacy endpoint was the retention rate at 12 months. Other endpoints included change in seizure frequency from baseline; pragmatic seizure freedom rate (proportion of PWE in the full analysis set achieving freedom from all seizures); responder rate (≥50% seizure frequency reduction from baseline), changes from baseline in the 10-item Quality of Life in Epilepsy questionnaire (QOLIE-10) total score, the Epworth Sleepiness Scale (ESS), and the age-corrected EpiTrack and EpiTrack Junior total score; safety/tolerability (treatment-emergent adverse events [TEAEs]); and PER dose.ResultsOf 184 PWE (Safety Set, n = 182; Full Analysis Set, n = 174), 135 (73.4%) completed the 12-month study. The mean PER dose was 4.7 mg/day. Retention rate at 12 months was 74.2% in the overall population, 81.8% in the 12 to <18 years age group, 74.3% in the 18 to <65 years age group, and 66.7% in the ≥65 years age group. Retention rates were similar between PWE with focal-onset seizures (74.5%) and GTCS (75.0%). The median reduction in monthly seizure frequency per 28 days from baseline to 12 months was 78.6% in the overall population, 92.3% in the 12 to <18 age group, 75.0% in the 18 to <65 years age group, and 87.5% in the ≥65 years age group. In the overall population, pragmatic seizure freedom rates at 12 months were 36.2% (all seizures), 34.1% (all focal seizures), and 45.5% (GTCS); the responder rate at 12 months was 64.4% in the overall population. In total, 52.7% of PWE experienced TEAEs, and 12.1% discontinued due to TEAEs. No significant changes were identified from baseline to 12 months in QOLIE-10, ESS, and the age-corrected EpiTrack and EpiTrack Junior scores.ConclusionPER was efficacious for focal and generalized seizures across all age groups and was generally well-tolerated, as demonstrated by the high retention rates at 12 months.https://www.frontiersin.org/articles/10.3389/fneur.2025.1533767/fullepilepsyfirst add-onfocal epilepsygeneralized epilepsyperampanelreal-world |
| spellingShingle | Sergey Burd Sergey Burd Giovanni Assenza Giovanni Assenza Sofia Quintas Francisco José Gil López Jan Wagner Anna Lebedeva Anna Lebedeva Pavel Vlasov Nina Pantina Anna Patten Samantha Goldman Ricardo Sáinz-Fuertes Marta Torres Arlandis Stanislas Lagarde Stanislas Lagarde Tobias Sejbaek Tobias Sejbaek Vadim Kharkovsky A Phase 4, multicenter, prospective, non-interventional, observational study to investigate the effectiveness and safety/tolerability of perampanel when used as first adjunctive therapy in routine clinical practice in people with epilepsy: Study 512 Frontiers in Neurology epilepsy first add-on focal epilepsy generalized epilepsy perampanel real-world |
| title | A Phase 4, multicenter, prospective, non-interventional, observational study to investigate the effectiveness and safety/tolerability of perampanel when used as first adjunctive therapy in routine clinical practice in people with epilepsy: Study 512 |
| title_full | A Phase 4, multicenter, prospective, non-interventional, observational study to investigate the effectiveness and safety/tolerability of perampanel when used as first adjunctive therapy in routine clinical practice in people with epilepsy: Study 512 |
| title_fullStr | A Phase 4, multicenter, prospective, non-interventional, observational study to investigate the effectiveness and safety/tolerability of perampanel when used as first adjunctive therapy in routine clinical practice in people with epilepsy: Study 512 |
| title_full_unstemmed | A Phase 4, multicenter, prospective, non-interventional, observational study to investigate the effectiveness and safety/tolerability of perampanel when used as first adjunctive therapy in routine clinical practice in people with epilepsy: Study 512 |
| title_short | A Phase 4, multicenter, prospective, non-interventional, observational study to investigate the effectiveness and safety/tolerability of perampanel when used as first adjunctive therapy in routine clinical practice in people with epilepsy: Study 512 |
| title_sort | phase 4 multicenter prospective non interventional observational study to investigate the effectiveness and safety tolerability of perampanel when used as first adjunctive therapy in routine clinical practice in people with epilepsy study 512 |
| topic | epilepsy first add-on focal epilepsy generalized epilepsy perampanel real-world |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2025.1533767/full |
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