Study 512 Design: Perampanel as First Adjunctive Therapy in Patients Aged ≥ 12 Years with Focal-onset Seizures or Generalized Tonic-clonic Seizures Associated with Genetic Generalized Epilepsy
Abstract number :
2.13
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2022
Submission ID :
2204570
Source :
www.aesnet.org
Presentation date :
12/4/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:25 AM
Authors :
Sofia Quintas, MD – Centro Hospitalar Universitário Lisboa Norte; Sergey Burd, MD – Pirogov Russian National Research Medical University; Giovanni Assenza, MD – Campus Bio-Medico University, Rome, Italy; Francisco José Gil López, MD – Hospital Universitari del Sagrat Cor, Barcelona, Spain; Jan Wagner, MD – University of Ulm and Universitäts- und Rehabilitationskliniken Ulm, Ulm, Germany; Anna Patten, PhD – Eisai Europe Ltd., Hatfield, Hertfordshire, UK; Ricardo Sáinz-Fuertes, LMS, MSc, MRCPsych, PhD – Eisai Europe Ltd., Hatfield, Hertfordshire, UK; Stanislas Lagarde, MD, PhD – Aix Marseille University, Assistance Publique Hôpitaux de Marseille and Institute of Neuroscience Systems, Timone Hospital, Epileptology Department, Marseille, France; Tobias Sejbaek, MD, PhD – Hospital Southwest Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark; Pavel Vlasov, MD, PhD – Moscow State University of General Medicine and Dentistry named after A.I. Evdokimov, Moscow, Russia; Vadim Kharkovskiy, MD – Moscow State University of General Medicine and Dentistry named after A.I. Evdokimov, Moscow, Russia; Anna Lebedeva, MD, PhD – Pirogov Russian National Research Medical University, Moscow, Russia
Rationale: Patients with uncontrolled seizures while on anti-seizure medication (ASM) monotherapy may require adjunctive therapy. In the U.S. and EU, perampanel is approved for focal-onset seizures (FOS), with/without focal to bilateral tonic-clonic seizures (FBTCS), in patients aged ≥ 4 years (U.S., monotherapy/adjunctive; EU, adjunctive), and generalized tonic-clonic seizures (GTCS) in patients aged ≥ 12 (≥ 7, EU) years (adjunctive). Study 512 (NCT04252846) is a prospective, observational, multicenter study (Figure 1) to assess the dosage, effectiveness, and safety of perampanel as adjunctive therapy in patients aged ≥ 12 years with FOS and/or GTCS associated with genetic generalized epilepsy (GGE) in clinical care in Europe. Here, we present the design of Study 512 in addition to interim study results.
Methods: Enrolled patients received perampanel as the first adjunctive therapy to ASM monotherapy per the investigator’s decision.
Key inclusion criteria: aged ≥ 12 years; diagnosis of epilepsy (FOS, with/without FBTCS, or GTCS associated with GGE); previously treated with ≤ 2 ASM monotherapies; available baseline seizure-frequency data.
Key exclusion criteria: episode(s) of status epilepticus in ≤ 6 months pre-screening; ≥ 2 ASMs in combination (except for cross-titration between ASM monotherapies); previous/current perampanel use. Patients will be assessed at baseline and as per routine clinical care, with study visits occurring at Months 6 and 12 post-baseline. The primary endpoint is retention rate at Month 12. Secondary endpoints include retention rate at Month 6, change in seizure frequency, responder/seizure-freedom/seizure-worsening rates at Months 6 and 12, dosing patterns, treatment duration, and safety. Descriptive statistics will be used for analysis.
Results: The study was initiated on July 20, 2020, and recruitment was terminated on December 23, 2021; 196 patients were enrolled at 45 study sites across ≥ 5 countries. Baseline demographics and clinical characteristics of enrolled patients are presented in Table 1. The mean (standard deviation) age of patients was 39.6 (19.6) years; the most common seizure type was FOS (n=151/194; 77.8%). Nearly all patients (n=186/188; 98.9%) were receiving one ASM at baseline; most commonly levetiracetam (n=82/191; 42.9%) and lamotrigine (n=29/191; 15.2%). Interim study results will be presented in the poster.
Conclusions: Study 512 will provide prospective, observational data on the real‑world use of perampanel as first adjunctive therapy in patients aged ≥ 12 years with epilepsy.
Funding: Eisai Inc.; Eisai Ltd.; Eisai Co., Ltd.
Clinical Epilepsy