Subscribe to RSS
Study on Effectiveness and Tolerability of Adjunctive Perampanel Treatment in Children with Refractory Epilepsy in a Tertiary Care Center
Background Nearly 30% of patients with epilepsy are refractory to currently available antiseizure drugs (ASDs). Although the U.S. Food and Drug Administration approved perampanel (PER) for patients as young as 4 years, there are limited data on using PER in children.
Objective The aim of this study was to determine the efficacy and tolerability of adjunctive PER treatment in children with refractory epilepsy (RE).
Methodology This prospective intervention study was conducted in the tertiary care center, in Bengaluru, India from December 2020 to May 2022. PER was added after the failure of a minimum of two ASDs and patients with 6 months follow-up. Treatment response was classified as complete, partial, or none with ≥90, ≥50, and <50% reduction in seizure frequency, respectively. Adverse events and discontinuation data were used to assess tolerability.
Results Our cohort consisted of 100 cases, a mean age of 9.3 ± 3.8 years and male:female ratio of 3:1. The predominant seizure type was generalized seizures (74%), and concomitant enzyme-inducing ASD use was noted in 27%. Structural etiology was noted in 57%. A total of 76% of participants responded to PER therapy (46% complete response and 30% partial response), while 23% showed no response and 1% discontinued the treatment. Adverse events were observed in 25% of participants (11/25 [44%] drowsiness/sedation, 10/25 [40%] behavioral problems, and 4 [16%] other side effects). Early PER add-on provided a statistically significant benefit over late PER add-on (p = 0.01). Response to PER did not differ significantly with the type of seizure and ASD used (p > 0.05).
Conclusion Adjunctive PER therapy is safe and effective for treating children with RE. An early add-on of PER is more beneficial in controlling seizures than a late add-on.
Received: 22 January 2023
Accepted: 01 April 2023
Article published online:
11 May 2023
© 2023. Thieme. All rights reserved.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
- 1 Engel Jr J. Approaches to refractory epilepsy. Ann Indian Acad Neurol 2014; 17 (Suppl. 01) S12-S17
- 2 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 (06) 1069-1077 Erratum in: Epilepsia 2010;51(9):1922
- 3 Beleza P. Refractory epilepsy: a clinically oriented review. Eur Neurol 2009; 62 (02) 65-71
- 4 Camfield P, Camfield C. Incidence, prevalence and aetiology of seizures and epilepsy in children. Epileptic Disord 2015; 17 (02) 117-123
- 5 Swiderska N, Tan HJ, Rajai A, Silwal A, Desurkar A, Martland T. Effectiveness and tolerability of perampanel in children, adolescents and young adults with refractory epilepsy: a UK national multicentre study. Seizure 2017; 52: 63-70
- 6 Rogawski MA, Hanada T. Preclinical pharmacology of perampanel, a selective non-competitive AMPA receptor antagonist. Acta Neurol Scand Suppl 2013; ;(197): 19-24
- 7 De Liso P, Moavero R, Coppola G. et al. Current role of perampanel in pediatric epilepsy. Ital J Pediatr 2017; 43 (01) 51
- 8 Chang FM, Fan PC, Weng WC, Chang CH, Lee WT. The efficacy of perampanel in young children with drug-resistant epilepsy. Seizure 2020; 75: 82-86
- 9 Plosker GL. Perampanel: as adjunctive therapy in patients with partial-onset seizures. CNS Drugs 2012; 26 (12) 1085-1096
- 10 Greenwood J, Valdes J. Perampanel (Fycompa): a review of clinical efficacy and safety in epilepsy. P&T 2016; 41 (11) 683-698
- 11 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 (01) 53-59
- 12 Lin KL, Lin JJ, Chou ML. et al. Efficacy and tolerability of perampanel in children and adolescents with pharmacoresistant epilepsy: the first real-world evaluation in Asian pediatric neurology clinics. Epilepsy Behav 2018; 85: 188-194
- 13 Daniel WW. ed. Biostatistics: A Foundation for Analysis in the Health Sciences. 7th ed. New York: John Wiley & Sons; 1999
- 14 Pourhoseingholi MA, Vahedi M, Rahimzadeh M. Sample size calculation in medical studies. Gastroenterol Hepatol Bed Bench 2013; 6 (01) 14-17
- 15 Yun Y, Kim D, Lee YJ, Kwon S, Hwang SK. Efficacy and tolerability of adjunctive perampanel treatment in children under 12 years of age with refractory epilepsy. Korean J Pediatr 2019; 62 (07) 269-273
- 16 Abril Jaramillo J, Estévez María JC, Girón Úbeda JM, Vega López Ó, Calzado Rivas ME, Pérez Díaz H. et al. Corrigendum to “Effectiveness and safety of perampanel as early add-on treatment in patients with epilepsy and focal seizures in the routine clinical practice: Spain prospective study (PERADON)”. Epilepsy Behav 2020; 104 (A): 106917
- 17 Nishida T, Lee SK, Inoue Y, Saeki K, Ishikawa K, Kaneko S. Adjunctive perampanel in partial-onset seizures: Asia-Pacific, randomized phase III study. Acta Neurol Scand 2018; 137 (04) 392-399