A non-inferiority randomized controlled study of Perampanel versus Oxcarbazepine monotherapy for post-stroke epilepsy

Cuihua Yan; Jing Liu; Jing Jiang; Yanping Sun; Juan Chen; Kunkun Wei; Xiaoyun Liu; Qi Xiang; Anru Liu; Yuxiang Han; Liling Yang; Tao Han; Xuewu Liu

doi:10.1016/j.seizure.2025.01.016

A non-inferiority randomized controlled study of Perampanel versus Oxcarbazepine monotherapy for post-stroke epilepsy

Seizure. 2025 Jan 11:125:172-178. doi: 10.1016/j.seizure.2025.01.016. Online ahead of print.

Authors

Cuihua Yan¹, Jing Liu², Jing Jiang³, Yanping Sun⁴, Juan Chen⁵, Kunkun Wei⁶, Xiaoyun Liu⁷, Qi Xiang⁸, Anru Liu⁸, Yuxiang Han⁷, Liling Yang⁷, Tao Han⁹, Xuewu Liu¹⁰

Affiliations

¹ Department of Neurology, Shandong Provincial Hospital, Shandong University, Jinan, Shandong, PR China; Department of Neurology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, PR China; Institute of Epilepsy, Shandong University, Jinan, Shandong, PR China; Department of Neurology, Qilu Hospital of Shandong University, Jinan, Shandong, PR China; Department of Critical Care Medicine, People's Hospital of Rizhao, No. 126 Taian Road, 276827, Rizhao, PR China.
² Department of Hyperbaric Oxygen Therapy, Shandong Provincial Third Hospital, Cheeloo College of Medicine, Shandong University, 250031, Jinan, China.
³ Department of Neurology, Shandong Provincial Hospital, Shandong University, Jinan, Shandong, PR China; Department of Neurology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, PR China; Institute of Epilepsy, Shandong University, Jinan, Shandong, PR China.
⁴ Qingdao University Affiliated Hospital, Qingdao, Shandong, PR China.
⁵ The Third People's Hospital of Heze City, Heze, Shandong, PR China.
⁶ Peking University People's Hospital, Qingdao, Women and Children's Hospital, QINGDAO UNIVERSITY, Shandong, PR China.
⁷ Department of Neurology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, PR China.
⁸ Department of Neurology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, PR China; Institute of Epilepsy, Shandong University, Jinan, Shandong, PR China.
⁹ Department of Neurology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, PR China; Institute of Epilepsy, Shandong University, Jinan, Shandong, PR China; Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, PR China. Electronic address: [email protected].
¹⁰ Department of Neurology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, PR China; Institute of Epilepsy, Shandong University, Jinan, Shandong, PR China. Electronic address: [email protected].

PMID: 39848108
DOI: 10.1016/j.seizure.2025.01.016

Abstract

Background: Post-stroke epilepsy (PSE) poses a significant challenge despite advances in stroke treatment. This study compares the efficacy of the novel anti-seizure medication (ASM) Perampanel with the classical ASM Oxcarbazepine in treating PSE.

Methods: This prospective randomized controlled trial recruited PSE patients from September 2022 to January 2024 across multiple hospitals. Patients were randomly assigned to receive either Perampanel or Oxcarbazepine monotherapy. Baseline seizure frequency was measured over three months prior to treatment. Efficacy was assessed at six months, with a ≥ 50 % reduction in seizure frequency deemed effective. Perampanel was considered non-inferior to Oxcarbazepine if its lower 95 % confidence limit for efficacy was above 80 % of Oxcarbazepine's six-month seizure freedom rate. Intention-to-treat analysis and Kaplan-Meier methods evaluated retention rates and side effects.

Results: A total of 67 patients were included in this study: 33 patients in the Perampanel group (26 males, 78.8 %; 7 females, 21.2 %) and 34 patients in the Oxcarbazepine group (26 males, 76.5 %; 8 females, 23.5 %). There were no statistically significant differences in the baseline data between the two groups. This indicates that the groups are comparable. Treatment efficacy was 75.0 % and 78.8 % in the Perampanel and Oxcarbazepine groups at three months, and 80.6 % and 75.0 % at six months, respectively. At six months, the lower limit of the 95 % confidence interval for efficacy in the Perampanel group was higher than the prespecified non-inferiority threshold, indicating that Perampanel was noninferior than Oxcarbazepine. The rates of drug retention and adverse effects were similar in the two groups, with no statistically significant difference (P > 0.05).

Conclusion: Perampanel is noninferior to Oxcarbazepine and is considered a good option for the management of post-stroke epilepsy.

Keywords: Anti-seizure medications; Clinical efficacy; Epilepsy; Oxcarbazepine; Perampanel; Safety.