Clinical study of the adjunctive treatment of perampanel in children with refractory epilepsy_Journal of Epilepsy

Authors：

ZHANG Jingwen ¹ , ZHANG Yuxin ¹ , LI Xufeng ¹ , LIANG Mingjuan ¹ , WANG Chun ² , GUO Yuxiong ² , CHEN Zhihong ¹ ,  ZHAI Qiongxiang ¹

1. Guangdong General Hospital (Guangdong Academy of Medical Sciences), Department of Pediatrics, Guangzhou 510080, China;
2. Pediatric Intensive Care Unit, Guangzhou 510080, China;

Corresponding author：

ZHAI Qiongxiang, Email: zhaiqiongxiang@sina.com

Keywords：

Perampanel; Refractory epilepsy; Effectiveness; Adverse reactions

DOI：

10.7507/2096-0247.202112007

Video：

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Objective To study the efficacy and adverse events of adjunctive perampanel in children with refractory epilepsy. Methods A prospective study was carried out in 45 children with refractory epilepsy, who were treated in our hospital from January 2020 to February 2021 using perampanel as an add-on treatment, with a criteria for enrollment and the starting dose of perampanel. Follow-up would be taken at once a month. Afte 3 months would check blood routine, liver function, kidney function and humoral immunity. The EEG was reviewed after 6 months. The initial dose of perampanel was 0.04 mg/(kg·d) (the maximum didn't exceed 2 mg/d), increasing by 0.04 mg/(kg·d) every two weeks, and the maximum maintenance dose didn't exceed 6 mg/d. The efficacy and adverse reactions of perampanel were evaluated by comparing the seizure frequency and EEG results before and after a 6-month add-on therapy.Results Among the 45 children,complete seizure control was achieved in 7 cases after the therapy, and the seizure attacks were reduced in 26 cases, showing a total response rate of 73.3%. After the treatment, the epileptiform discharge of 28 children was reduced, and the effective rate was 62.22%. During the observation period, all the blood routine, liver function, kidney function,and humoral immunity of the children were normal.10 cases of adverse reactions occurred after the additional treatment of perampanel, and the adverse reaction rate was 22.22%. Conclusions Perampanel has good efficacy and safety in the add-on treatment of refractory epilepsy.

Citation： ZHANG Jingwen, ZHANG Yuxin, LI Xufeng, LIANG Mingjuan, WANG Chun, GUO Yuxiong, CHEN Zhihong, ZHAI Qiongxiang. Clinical study of the adjunctive treatment of perampanel in children with refractory epilepsy. Journal of Epilepsy, 2022, 8(3): 232-235. doi: 10.7507/2096-0247.202112007 Copy

1.	Kwan P, Arzimanoglou A, Berg AT, et al. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia, 2010, 51(6): 1069-1077.
2.	Leo A, Giovannini G, Russo E, et al. The role of ampa receptors and their antagonists in status epilepticus. Epilepsia, 2018, 59(6): 1098-1108.
3.	周永, 刘民, 梁万年. 癫痫流行病学研究进展. 中华流行病学杂志, 2007, 28(1): 92-94.
4.	Fisher RS, Cross JH, French JA, et al. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia, 2017, 58(Suppl.): 522-530.
5.	张宇昕, 翟琼香, 汤志鸿, 等. 左乙拉西坦添加治疗小儿额叶癫痫: 附105例报告. 南方医科大学学报, 2014, (3): 364-367.
6.	Krauss GL, Perucca E, Kwan P, et al. Final safety, tolerability, and seizure outcomes in patients with focal epilepsy treated with adjunctive perampanel for up to 4 years in an open-label extension of phase iii randomized trials: Study 307. Epilepsia, 2018, 59(4): 866-876.
7.	褚思嘉, 汤继宏. 第三代新型ASMs吡仑帕奈在癫痫治疗中的研究进展. 癫痫杂志, 2021, 7(1): 58-61.
8.	Pina-Garza JE, Rosenfeld W, Saeki K, et al. Efficacy and safety of adjunctive perampanel in adolescent patients with epilepsy: Post hoc analysis of six randomized studies. Epilepsy Behav, 2020: 104.
9.	Rektor I, Krauss GL, Inoue Y, et al. Assessment of the long-term efficacy and safety of adjunctive perampanel in tonic-clonic seizures: Analysis of four open-label extension studies. Epilepsia, 2020, 61(7): 1491-1502.
10.	Fogarasi A, Flamini R, Milh M, et al. Open-label study to investigate the safety and efficacy of adjunctive perampanel in pediatric patients (4 to < 12 years) with inadequately controlled focal seizures or generalized tonic-clonic seizures. Epilepsia, 2020, 61(1): 125-137.
11.	Chen T, Dai SH, Jiang ZQ, et al. The AMPAR Antagonist perampanel attenuates traumatic brain injury through anti-oxidative and anti-inflammatory activity. Cell Mol Eurobiol, 2017, 37(1): 43-52.
12.	Nishida T, Lee SK, Inoue Y, et al. Adjunctive perampanel in partial-onset seizures: Asia-pacific, randomized phase iii study. Acta Neurol Scand, 2018, 137(4): 392-399.
13.	Ishikawa N, Tateishi Y, Tani H, et al. Clinical profiles associated with serum perampanel concentrations in children with refractory epilepsy. Epilepsy Behav, 2019, 94: 82-86.
14.	Ikemoto S, Hamano S, Hirata Y, et al. Efficacy and serum concentrations of perampanel for treatment of drug-resistant epilepsy in children, adolescents, and young adults: comparison of patients younger and older than 12 years. Seizure-Eur J Epilep, 2019, 73: 75-78.
15.	Hwang SK, Lee YJ, Nam SO, et al. Real-life effectiveness and tolerability of perampanel in pediatric patients aged 4 years or older with epilepsy: a Korean national multicenter study. J Clin Neurol, 2020, 16(1): 53-59.
16.	褚思嘉, 汤继宏, 李岩, 等. 吡仑帕奈治疗儿童难治性癫痫的疗效和安全性研究. 癫痫杂志, 2021, 7(5): 385-391.
17.	Trinka E, Steinhoff BJ, Nikanorova M, et al. Perampanel for focal epilepsy: Insights from early clinical experience. Acta Neurol Scand, 2016, 133(3): 160-172.

1. Kwan P, Arzimanoglou A, Berg AT, et al. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia, 2010, 51(6): 1069-1077.
2. Leo A, Giovannini G, Russo E, et al. The role of ampa receptors and their antagonists in status epilepticus. Epilepsia, 2018, 59(6): 1098-1108.
3. 周永, 刘民, 梁万年. 癫痫流行病学研究进展. 中华流行病学杂志, 2007, 28(1): 92-94.
4. Fisher RS, Cross JH, French JA, et al. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia, 2017, 58(Suppl.): 522-530.
5. 张宇昕, 翟琼香, 汤志鸿, 等. 左乙拉西坦添加治疗小儿额叶癫痫: 附105例报告. 南方医科大学学报, 2014, (3): 364-367.
6. Krauss GL, Perucca E, Kwan P, et al. Final safety, tolerability, and seizure outcomes in patients with focal epilepsy treated with adjunctive perampanel for up to 4 years in an open-label extension of phase iii randomized trials: Study 307. Epilepsia, 2018, 59(4): 866-876.
7. 褚思嘉, 汤继宏. 第三代新型ASMs吡仑帕奈在癫痫治疗中的研究进展. 癫痫杂志, 2021, 7(1): 58-61.
8. Pina-Garza JE, Rosenfeld W, Saeki K, et al. Efficacy and safety of adjunctive perampanel in adolescent patients with epilepsy: Post hoc analysis of six randomized studies. Epilepsy Behav, 2020: 104.
9. Rektor I, Krauss GL, Inoue Y, et al. Assessment of the long-term efficacy and safety of adjunctive perampanel in tonic-clonic seizures: Analysis of four open-label extension studies. Epilepsia, 2020, 61(7): 1491-1502.
10. Fogarasi A, Flamini R, Milh M, et al. Open-label study to investigate the safety and efficacy of adjunctive perampanel in pediatric patients (4 to < 12 years) with inadequately controlled focal seizures or generalized tonic-clonic seizures. Epilepsia, 2020, 61(1): 125-137.
11. Chen T, Dai SH, Jiang ZQ, et al. The AMPAR Antagonist perampanel attenuates traumatic brain injury through anti-oxidative and anti-inflammatory activity. Cell Mol Eurobiol, 2017, 37(1): 43-52.
12. Nishida T, Lee SK, Inoue Y, et al. Adjunctive perampanel in partial-onset seizures: Asia-pacific, randomized phase iii study. Acta Neurol Scand, 2018, 137(4): 392-399.
13. Ishikawa N, Tateishi Y, Tani H, et al. Clinical profiles associated with serum perampanel concentrations in children with refractory epilepsy. Epilepsy Behav, 2019, 94: 82-86.
14. Ikemoto S, Hamano S, Hirata Y, et al. Efficacy and serum concentrations of perampanel for treatment of drug-resistant epilepsy in children, adolescents, and young adults: comparison of patients younger and older than 12 years. Seizure-Eur J Epilep, 2019, 73: 75-78.
15. Hwang SK, Lee YJ, Nam SO, et al. Real-life effectiveness and tolerability of perampanel in pediatric patients aged 4 years or older with epilepsy: a Korean national multicenter study. J Clin Neurol, 2020, 16(1): 53-59.
16. 褚思嘉, 汤继宏, 李岩, 等. 吡仑帕奈治疗儿童难治性癫痫的疗效和安全性研究. 癫痫杂志, 2021, 7(5): 385-391.
17. Trinka E, Steinhoff BJ, Nikanorova M, et al. Perampanel for focal epilepsy: Insights from early clinical experience. Acta Neurol Scand, 2016, 133(3): 160-172.

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