Efficacy and safety study of perampanel monotherapy in self-limited epilepsy with central temporal spikes_Journal of Epilepsy

Authors：

YUE Xuan ,  LIU Xiaoming , CHEN Jiao , LIU Li , ZHAO Jiaqiang , SHI Na , ZHENG Nuo

Department of Neurology, Xuzhou Children's Hospital, Xuzhou 221006, China;

Corresponding author：

LIU Xiaoming, Email: xzlrlxm@163.com

Keywords：

Perampanel; Self-limited epilepsy with centrotemporal spikes; Children

DOI：

10.7507/2096-0247.202306012

Video：

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Objective To investigate the efficacy and safety of Perampanel (PER) monotherapy in the treatment of self limited epilepsy with central temporal spikes (SeLECTS). Methods The clinical data of the first confirmed SelECTS in the outpatient and inpatient department of Xuzhou Children's Hospital affiliated to Xuzhou Medical University in December 2021 were collected, and the clinical data of PER monotherapy were retrospectively analyzed. The Seizure of 12 months old children were followed up to observe the efficacy and safety of PER monotherapy with spikes in the central temporal region, and the changes of Electroencephalography were observed. Result A total of 45 children with SeLECTS were included, of which 43 had complete medical records, including 13 males and 30 females, aged 4 ~ 14 years old, with a course of disease ranging from 1 month to 1.5 years. All 45 patients had focal seizures or focal secondary generalized tonic clonic seizures. Among them, 43 patients treated with PER alone for 12 months had epilepsy control efficacy rates of 74.41% (32/43) and no seizure rates of 60.46% (26/43), respectively. Seven children (15.56%, 7/45) experienced adverse reactions, characterized by dizziness, unstable gait, and irritability. Conclusion The third generation anti Seizure drug PER has a clear effect in the treatment of SelECTS, 2 ~ 4 mg PER can control Seizure well, and has no significant impact on cognitive development.

Citation： YUE Xuan, LIU Xiaoming, CHEN Jiao, LIU Li, ZHAO Jiaqiang, SHI Na, ZHENG Nuo. Efficacy and safety study of perampanel monotherapy in self-limited epilepsy with central temporal spikes. Journal of Epilepsy, 2023, 9(5): 388-392. doi: 10.7507/2096-0247.202306012 Copy

1.	Potschka H, Trinka E. Perampanel: does it have broad-spectrum potential? Epilepsia, 2019, 60(Suppl 1): 22-36.
2.	Sills GJ, Rogawski MA. Mechanisms of action of currently used antiseizure drugs . Neuropharmacology, 2020, 168(5): 107966.
3.	刘晓燕. 临床脑电图学(第2版). 北京: 人民卫生出版社, 2017: 335.
4.	Yamamoto T, Gil-Nagel A, Wheless JW, et al. Perampanel monotherapy for the treatment of epilepsy: clinical trial and real-world evidence. Epilepsy Behav, 2022, 136: 108885.
5.	梁锦平. 国际抗癫痫联盟2017年版癫痫分类特点及其解读 . 中国实用儿科杂志, 2020, 35(1): 47-54.
6.	French JA, Krauss GL, Biton V, et al. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology, 2012, 79(6): 589–596.
7.	French JA, Krauss GL, Steinhoff BJ, et al. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: results of randomized global phase III study 305. Epilepsia, 2013, 54(1): 117–125.
8.	Krauss GL, Serratosa JM, Villanueva V, et al. Randomized phase III study 306: adjunctive perampanel for refractory partial-onset seizures. Neurology, 2012, 8(18): 1408–1415.
9.	Gil-Nagel A, Burd S, Toledo M, et al. A retrospective, multicentre study of perampanel given as monotherapy in routine clinical care in people with epilepsy. Seizure, 2018, 54: 61–66.
10.	Husni RE, Ngo LY, Senokuchi H, et al. Experience of perampanel monotherapy beyond initial titration to achieve seizure freedom in patients with focal-onset seizures with newly diagnosed or currently untreated recurrent epilepsy: a post hoc analysis of the open-label study 342 (FREEDOM). Epilepsia Open, 2022, 7(1): 59–66.
11.	樊海珍, 王燕梅, 韩虹, 等. PER添加治疗儿童局灶性癫痫疗效与安全性观察. 中国药物与临床, 2021, 21(14): 2524-2526 .
12.	Brodie MJ, Stephen LJ. Prospective audit with adjunctive perampanel: preliminary observations in focal epilepsy. Epilepsy Behav, 2016, 54: 100-103.
13.	Garamendi-Ruiz I, García-García ME, Bertol-Alegre V, et al. One-year clinical experience of perampanel in Spain: a multicentre study of efficacy and tolerability. Epileptic Disord, 2016, 18: 173-180.
14.	Maurousset A, Limousin N, Praline J, et al. Adjunctive perampanel in refractory epilepsy: experience at tertiary epilepsy care center in Tours . Epilepsy Behav, 2016, 61: 237-241.
15.	Villanueva V, GarcésM, López-González FJ, et al. Safety, efficacy and outcome-related factors of perampanel over 12 months in a real-world setting: the FYDATA study. Epilepsy Res, 2016, 126: 201-210.
16.	Heyman E, Lahat E, LeVin N, et al. Tolerability and efficacy of perampanel in children with refractory epilepsy. Dev Med Child Neurol, 2017, 59: 441-444.
17.	Datta AN, Xu Q, Sachedina S, et al. Clinical experience with perampanel for refractory pediatric epilepsy in one Canadian center. J Child Neurol, 2017, 32: 834-839.
18.	Swiderska N, Tan HJ, Rajai A, et al. Effectiveness and tolerability of perampanel in children, adolescents and young adults with refractory epilepsy: a UK national multicentre study. Seizure, 2017, 52: 63-70.
19.	Biró A, Stephani U, Tarallo T, et al. Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies: first experiences. Neuropediatrics, 2015, 46: 110-115.
20.	De Liso P, Vigeano F, Specchio N, et al. Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies: an Italian observational multicenter study. Epilepsy Res, 2016, 127: 93-100.
21.	Stein hoff BJ, Hamer H, Trinka E, et al. A multi-center survey of clinical experiences with perampanel in real life in Germany and Austria. Epilepsy Res, 2014, 108(5): 986-988.

1. Potschka H, Trinka E. Perampanel: does it have broad-spectrum potential? Epilepsia, 2019, 60(Suppl 1): 22-36.
2. Sills GJ, Rogawski MA. Mechanisms of action of currently used antiseizure drugs . Neuropharmacology, 2020, 168(5): 107966.
3. 刘晓燕. 临床脑电图学(第2版). 北京: 人民卫生出版社, 2017: 335.
4. Yamamoto T, Gil-Nagel A, Wheless JW, et al. Perampanel monotherapy for the treatment of epilepsy: clinical trial and real-world evidence. Epilepsy Behav, 2022, 136: 108885.
5. 梁锦平. 国际抗癫痫联盟2017年版癫痫分类特点及其解读 . 中国实用儿科杂志, 2020, 35(1): 47-54.
6. French JA, Krauss GL, Biton V, et al. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology, 2012, 79(6): 589–596.
7. French JA, Krauss GL, Steinhoff BJ, et al. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: results of randomized global phase III study 305. Epilepsia, 2013, 54(1): 117–125.
8. Krauss GL, Serratosa JM, Villanueva V, et al. Randomized phase III study 306: adjunctive perampanel for refractory partial-onset seizures. Neurology, 2012, 8(18): 1408–1415.
9. Gil-Nagel A, Burd S, Toledo M, et al. A retrospective, multicentre study of perampanel given as monotherapy in routine clinical care in people with epilepsy. Seizure, 2018, 54: 61–66.
10. Husni RE, Ngo LY, Senokuchi H, et al. Experience of perampanel monotherapy beyond initial titration to achieve seizure freedom in patients with focal-onset seizures with newly diagnosed or currently untreated recurrent epilepsy: a post hoc analysis of the open-label study 342 (FREEDOM). Epilepsia Open, 2022, 7(1): 59–66.
11. 樊海珍, 王燕梅, 韩虹, 等. PER添加治疗儿童局灶性癫痫疗效与安全性观察. 中国药物与临床, 2021, 21(14): 2524-2526 .
12. Brodie MJ, Stephen LJ. Prospective audit with adjunctive perampanel: preliminary observations in focal epilepsy. Epilepsy Behav, 2016, 54: 100-103.
13. Garamendi-Ruiz I, García-García ME, Bertol-Alegre V, et al. One-year clinical experience of perampanel in Spain: a multicentre study of efficacy and tolerability. Epileptic Disord, 2016, 18: 173-180.
14. Maurousset A, Limousin N, Praline J, et al. Adjunctive perampanel in refractory epilepsy: experience at tertiary epilepsy care center in Tours . Epilepsy Behav, 2016, 61: 237-241.
15. Villanueva V, GarcésM, López-González FJ, et al. Safety, efficacy and outcome-related factors of perampanel over 12 months in a real-world setting: the FYDATA study. Epilepsy Res, 2016, 126: 201-210.
16. Heyman E, Lahat E, LeVin N, et al. Tolerability and efficacy of perampanel in children with refractory epilepsy. Dev Med Child Neurol, 2017, 59: 441-444.
17. Datta AN, Xu Q, Sachedina S, et al. Clinical experience with perampanel for refractory pediatric epilepsy in one Canadian center. J Child Neurol, 2017, 32: 834-839.
18. Swiderska N, Tan HJ, Rajai A, et al. Effectiveness and tolerability of perampanel in children, adolescents and young adults with refractory epilepsy: a UK national multicentre study. Seizure, 2017, 52: 63-70.
19. Biró A, Stephani U, Tarallo T, et al. Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies: first experiences. Neuropediatrics, 2015, 46: 110-115.
20. De Liso P, Vigeano F, Specchio N, et al. Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies: an Italian observational multicenter study. Epilepsy Res, 2016, 127: 93-100.
21. Stein hoff BJ, Hamer H, Trinka E, et al. A multi-center survey of clinical experiences with perampanel in real life in Germany and Austria. Epilepsy Res, 2014, 108(5): 986-988.

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Efficacy and safety study of perampanel monotherapy in self-limited epilepsy with central temporal spikes

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