epilepsiaEpilepsy and paroxysmal conditionsЭпилепсия и пароксизмальные состояния2077-83332311-4088IRBIS LLC10.17749/2077-8333/epi.par.con.2021.107epilepsia-747Research ArticleEVENTSСОБЫТИЯThe Resolution of the Russian League Against Epilepsy Working Group Meeting (September 25, 2021, Moscow)Резолюция заседания рабочей группы Российской Противоэпилептической Лиги (25 сентября 2021 г., Москва)РедакционнаястатьяEditorialArticle202114012022134393398Copyright © Editorial a., 20222022Редакционная с.Editorial a.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.epilepsia.su/jour/article/view/747

On September 25, 2021, the Russian League Against Epilepsy (RLAE) Working Group Meeting was held regarding approaches to therapy of pediatric focal epilepsy. Considering the experience of the world medical community and Russian epileptologists, the participants discussed issues related to administering diverse anti-epilepsy agents in this patient cohort. It was noted that an ideal therapy might provide rapid and long-lasting seizure control, few side effects, low potential of drug interaction, good compliance and adherence to therapy, and no effects on course of comorbidities. The article presents the Resolution of the RLAE Working Group Meeting that was approved after discussion.

25 сентября 2021 г. состоялось заседание рабочей группы Российской Противоэпилептической Лиги (РПЭЛ) по подходам к терапии фокальной эпилепсии у детей. Учитывая опыт мирового врачебного сообщества и российских эпилептологов, участники обсудили проблемы, связанные с использованием различных антиэпилептических препаратов у пациентов данной категории. Было отмечено, что идеальная терапия должна обеспечить быстрый и длительный контроль приступов, минимум побочных эффектов, низкий потенциал межлекарственного взаимодействия, хорошие показатели приверженности и удержания на терапии, отсутствие влияния на течение сопутствующих заболеваний. В статье представлена Резолюция заседания рабочей группы РПЭЛ, принятая экспертами в результате дискуссии.

фокальная эпилепсиядетиэффективность терапииантиэпилептические препаратыблокаторы натриевых каналовлакосамидклинические исследованияпереносимость препаратакогнитивные функциипобочные эффектыприверженность терапиикачество жизниfocal epilepsychildrentherapeutic efficacyantiepileptic drugssodium channel blockerslacosamideclinical trialsdrug tolerancecognitive functionsside effectsadherence to therapyquality of lifeМероприятие организовано при поддержке ООО «ЮСБ Фарма».The event was organized with the support of UCB Pharma LLC.ReferencesArya R., Glauser T.A. Pharmacotherapy of focal epilepsy in children: a systematic review of approved agents. CNS Drugs. 2013; 27 (4): 273–86. https://doi.org/10.1007/s40263-013-0048-z.Arya R., Glauser T.A. Pharmacotherapy of focal epilepsy in children: a systematic review of approved agents. CNS Drugs. 2013; 27 (4): 273–86. https://doi.org/10.1007/s40263-013-0048-z.Ferreira J.A., Le Pichon J.B., Abdelmoity A.T., et al. Safety and tolerability of adjunctive lacosamide in a pediatric population with focal seizures – an open-label trial. Seizure. 2019; 71: 166–73. https://doi.org/10.1016/j.seizure.2019.05.016.Ferreira J.A., Le Pichon J.B., Abdelmoity A.T., et al. Safety and tolerability of adjunctive lacosamide in a pediatric population with focal seizures – an open-label trial. Seizure. 2019; 71: 166–73. https://doi.org/10.1016/j.seizure.2019.05.016.French J.A., Staley B.A. AED treatment through different ages: as our brains change, should our drug choices also? Epilepsy Curr. 2012; 12 (Suppl. 3): 22–7. https://doi.org/10.5698/1535-7511-12.4s.22.French J.A., Staley B.A. AED treatment through different ages: as our brains change, should our drug choices also? Epilepsy Curr. 2012; 12 (Suppl. 3): 22–7. https://doi.org/10.5698/1535-7511-12.4s.22.European Medicines Agency. Guideline on clinical investigation of medicinal products in the treatment ofepileptic disorders. 22 July 2010. URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070043.pdf. (дата обращения 29.10.2021).European Medicines Agency. Guideline on clinical investigation of medicinal products in the treatment ofepileptic disorders. 22 July 2010. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070043.pdf. (accessed 29.10.2021).Hadjiloizou S.M., Bourgeois B.F. Antiepileptic drug treatment in children. Expert Rev Neurother. 2007; 7 (2): 179–93. https://doi.org/10.1586/14737175.7.2.179.Hadjiloizou S.M., Bourgeois B.F. Antiepileptic drug treatment in children. Expert Rev Neurother. 2007; 7 (2): 179–93. https://doi.org/10.1586/14737175.7.2.179.Zuberi S.M., Symonds J.D. Update on diagnosis and management of childhood epilepsies. J Pediatr (Rio J). 2015; 91 (6 Suppl. 1): S67–77. https://doi.org/10.1016/j.jped.2015.07.003.Zuberi S.M., Symonds J.D. Update on diagnosis and management of childhood epilepsies. J Pediatr (Rio J). 2015; 91 (6 Suppl. 1): S67–77. https://doi.org/10.1016/j.jped.2015.07.003.Guerrini R., Rosati A., Bradshaw K., Giorgi L. Adjunctive zonisamide therapy in the long-term treatment of children with partial epilepsy: results of an open-label extension study of a phase III, randomized, double-blind, placebo-controlled trial. Epilepsia. 2014; 55 (4): 568–78. https://doi.org/10.1111/epi.12548.Guerrini R., Rosati A., Bradshaw K., Giorgi L. Adjunctive zonisamide therapy in the long-term treatment of children with partial epilepsy: results of an open-label extension study of a phase III, randomized, double-blind, placebo-controlled trial. Epilepsia. 2014; 55 (4): 568–78. https://doi.org/10.1111/epi.12548.Schiemann-Delgado J., Yang H., de la Loge C., et al. A long-term open-label extension study assessing cognition and behavior, tolerability, safety, and efficacy of adjunctive levetiracetam in children aged 4 to 16 years with partial-onset seizures. J Child Neurol. 2012; 27 (1): 80–9. https://doi.org/10.1177/0883073811417183.Schiemann-Delgado J., Yang H., de la Loge C., et al. A long-term open-label extension study assessing cognition and behavior, tolerability, safety, and efficacy of adjunctive levetiracetam in children aged 4 to 16 years with partial-onset seizures. J Child Neurol. 2012; 27 (1): 80–9. https://doi.org/10.1177/0883073811417183.Guerrini R., Rosati A., Bradshaw K., Giorgi L. P51 – 1765 Safety and potential impact on growth and developmental skills of long-term adjunctive zonisamide therapy in paediatric patients with partial epilepsy. Eur J Paediatr Neurol. 2013; 17 (Suppl. 1): S68. https://doi.org/10.1016/S1090-3798(13)70230-7.Guerrini R., Rosati A., Bradshaw K., Giorgi L. P51 – 1765 Safety and potential impact on growth and developmental skills of long-term adjunctive zonisamide therapy in paediatric patients with partial epilepsy. Eur J Paediatr Neurol. 2013; 17 (Suppl. 1): S68. https://doi.org/10.1016/S1090-3798(13)70230-7.Kwan P., Brodie M.J. Early identification of refractory epilepsy. N Engl J Med. 2000; 342 (5): 314–9. https://doi.org/10.1056/NEJM200002033420503.Kwan P., Brodie M.J. Early identification of refractory epilepsy. N Engl J Med. 2000; 342 (5): 314–9. https://doi.org/10.1056/NEJM200002033420503.Glauser T.A., Pellock J.M., Bebin E.M., et al. Efficacy and safety of levetiracetam in children with partial seizures: an open-label trial. Epilepsia. 2002; 43 (5): 518–24. https://doi.org/10.1046/j.1528-1157.2002.13101.x.Glauser T.A., Pellock J.M., Bebin E.M., et al. Efficacy and safety of levetiracetam in children with partial seizures: an open-label trial. Epilepsia. 2002; 43 (5): 518–24. https://doi.org/10.1046/j.1528-1157.2002.13101.x.Appleton R., Fichtner K., LaMoreaux L., et al. Gabapentin as add-on therapy in children with refractory partial seizures: a 12-week, multicentre, double-blind, placebo-controlled study. Gabapentin Paediatric Study Group. Epilepsia. 1999; 40 (8): 1147–54. https://doi.org/10.1111/j.1528-1157.1999.tb00833.x.Appleton R., Fichtner K., LaMoreaux L., et al. Gabapentin as add-on therapy in children with refractory partial seizures: a 12-week, multicentre, double-blind, placebo-controlled study. Gabapentin Paediatric Study Group. Epilepsia. 1999; 40 (8): 1147–54. https://doi.org/10.1111/j.1528-1157.1999.tb00833.x.Glauser T., Arzimanoglou A., Litzinger M., et al. Efficacy and safety of rufinamide as adjunctive therapy for inadequately controlled partial seizures in pediatric patients. URL: https://www.aesnet.org/abstractslisting/efficacy-and-safety-of-rufinamide-as-adjunctivetherapy-for-inadequately-controlled-partial-seizures-in-pediatricpatients (дата обращения 29.10.2021).Glauser T., Arzimanoglou A., Litzinger M., et al. Efficacy and safety of rufinamide as adjunctive therapy for inadequately controlled partial seizures in pediatric patients. Available at: https://www.aesnet.org/abstractslisting/efficacy-and-safety-of-rufinamide-as-adjunctivetherapy-for-inadequately-controlled-partial-seizures-in-pediatricpatients (accessed 29.10.2021).Glauser T., Ben-Menachem E., Bourgeois B., et al. ILAE treatment guidelines: evidence-based analysis of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia. 2006; 47 (7): 1094–120. https://doi.org/10.1111/j.1528-1167.2006.00585.x.Glauser T., Ben-Menachem E., Bourgeois B., et al. ILAE treatment guidelines: evidence-based analysis of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia. 2006; 47 (7): 1094–120. https://doi.org/10.1111/j.1528-1167.2006.00585.x.Glauser T.A., Nigro M., Sachdeo R., et al. Adjunctive therapy with oxcarbazepine in children with partial seizures. The Oxcarbazepine Pediatric Study Group. Neurology. 2000; 54 (12): 2237–44. https://doi.org/10.1212/wnl.54.12.2237.Glauser T.A., Nigro M., Sachdeo R., et al. Adjunctive therapy with oxcarbazepine in children with partial seizures. The Oxcarbazepine Pediatric Study Group. Neurology. 2000; 54 (12): 2237–44. https://doi.org/10.1212/wnl.54.12.2237.Glauser T.A., Sfikas N. Oxcarbazepine adjunctive therapy in children with inadequately controlled partial seizures: an analysis of seizure-free rates. URL: https://www.aesnet.org/abstractslisting/oxcarbazepine-adjunctive-therapy-in-children-with-inadequatelycontrolled-partial-seizures--an-analysis-of-seizure-free-rates (дата обращения 29.10.2021).Glauser T.A., Sfikas N. Oxcarbazepine adjunctive therapy in children with inadequately controlled partial seizures: an analysis of seizure-free rates. Available at: https://www.aesnet.org/abstractslisting/oxcarbazepine-adjunctive-therapy-in-children-with-inadequatelycontrolled-partial-seizures--an-analysis-of-seizure-free-rates (accessed 29.10.2021).Glauser T.A., Dlugos D.J., Dodson W.E., et al. Topiramate monotherapy in newly diagnosed epilepsy in children and adolescents. J Child Neurol. 2007; 22 (6): 693–9. https://doi.org/10.1177/0883073807303997.Glauser T.A., Dlugos D.J., Dodson W.E., et al. Topiramate monotherapy in newly diagnosed epilepsy in children and adolescents. J Child Neurol. 2007; 22 (6): 693–9. https://doi.org/10.1177/0883073807303997.Jung D.E., Yu R., Yoon J.R., et al. Neuropsychological effects of levetiracetam and carbamazepine in children with focal epilepsy. Neurology. 2015; 84 (23): 2312–9. https://doi.org/10.1212/WNL.0000000000001661.Jung D.E., Yu R., Yoon J.R., et al. Neuropsychological effects of levetiracetam and carbamazepine in children with focal epilepsy. Neurology. 2015; 84 (23): 2312–9. https://doi.org/10.1212/WNL.0000000000001661.Eun S.H., Eun B.L., Lee J.S., et al. Effects of lamotrigine on cognition and behavior compared to carbamazepine as monotherapy for children with partial epilepsy. Brain Dev. 2012; 34 (10): 818–23. https://doi.org/10.1016/j.braindev.2012.03.006.Eun S.H., Eun B.L., Lee J.S., et al. Effects of lamotrigine on cognition and behavior compared to carbamazepine as monotherapy for children with partial epilepsy. Brain Dev. 2012; 34 (10): 818–23. https://doi.org/10.1016/j.braindev.2012.03.006.Kang H.C., Eun B.L., Lee C.W., et al. The effects on cognitive function and behavioral problems of topiramate compared to carbamazepine as monotherapy for children with benign rolandic epilepsy. Epilepsia. 2007; 48 (9): 1716–23. https://doi.org/10.1111/j.1528-1167.2007.01160.x.Kang H.C., Eun B.L., Lee C.W., et al. The effects on cognitive function and behavioral problems of topiramate compared to carbamazepine as monotherapy for children with benign rolandic epilepsy. Epilepsia. 2007; 48 (9): 1716–23. https://doi.org/10.1111/j.1528-1167.2007.01160.x.Appleton R., Fichtner K., LaMoreaux L., et al. Gabapentin as add-on therapy in children with refractory partial seizures: a 24-week, multicentre, open-label study. Dev Med Child Neurol. 2001; 43 (4): 269–73. https://doi.org/10.1017/s0012162201000500.Appleton R., Fichtner K., LaMoreaux L., et al. Gabapentin as add-on therapy in children with refractory partial seizures: a 24-week, multicentre, open-label study. Dev Med Child Neurol. 2001; 43 (4): 269–73. https://doi.org/10.1017/s0012162201000500.Levisohn P.M., Mintz M., Hunter S.J., et al. Neurocognitive effects of adjunctive levetiracetam in children with partial-onset seizures: a randomized, double-blind, placebo-controlled, noninferiority trial. Epilepsia. 2009; 50 (11): 2377–89. https://doi.org/10.1111/j.1528-1167.2009.02197.x.Levisohn P.M., Mintz M., Hunter S.J., et al. Neurocognitive effects of adjunctive levetiracetam in children with partial-onset seizures: a randomized, double-blind, placebo-controlled, noninferiority trial. Epilepsia. 2009; 50 (11): 2377–89. https://doi.org/10.1111/j.1528-1167.2009.02197.x.Donati F., Gobbi G., Campistol J., et al. Effects of oxcarbazepine on cognitive function in children and adolescents with partial seizures. Neurology. 2006; 67 (4): 679–82. https://doi.org/10.1212/01.wnl.0000230138.46508.5b.Donati F., Gobbi G., Campistol J., et al. Effects of oxcarbazepine on cognitive function in children and adolescents with partial seizures. Neurology. 2006; 67 (4): 679–82. https://doi.org/10.1212/01.wnl.0000230138.46508.5b.Renfroe B.J., Lagae L., Williams B., et al. Adjunctive perampanel in adolescents with inadequately controlled partial seizures: efficacy and safety results from study 235 (phase II) (P7.008). Neurology. 2015: 84 (14 Suppl.).Renfroe B.J., Lagae L., Williams B., et al. Adjunctive perampanel in adolescents with inadequately controlled partial seizures: efficacy and safety results from study 235 (phase II) (P7.008). Neurology. 2015: 84 (14 Suppl.).Wilfong A.A. Seizures and epilepsy in children: initial treatment and monitoring. URL: https://www.uptodate.com/contents/seizures-andepilepsy-in-children-initial-treatment-and-monitoring?search=seizures-and-epilepsy-in-children-initialtreatment-monitoring&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1 (дата обращения 29.10.2021).Wilfong A.A. Seizures and epilepsy in children: initial treatment and monitoring. Available at: https://www.uptodate.com/contents/seizures-and-epilepsy-in-children-initial-treatment-and-monitoring?search=seizures-and-epilepsy-in-children-initialtreatment-monitoring&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1 (accessed 29.10.2021).Lin J., Mula M., Hermann B. Uncovering the lifespan neurobehavioural comorbidities of epilepsy. Lancet. 2012; 380 (9848): 1180–92. https://doi.org/10.1016/S0140-6736(12)61455-X.Lin J., Mula M., Hermann B. Uncovering the lifespan neurobehavioural comorbidities of epilepsy. Lancet. 2012; 380 (9848): 1180–92. https://doi.org/10.1016/S0140-6736(12)61455-X.Thigpen J., Miller S.E., Pond B.B. Behavioral side effects of antiepileptic drugs. URL: https://www.uspharmacist.com/article/behavioral-side-effects-of-antiepileptic-drugs (дата обращения 29.10.2021).Thigpen J., Miller S.E., Pond B.B. Behavioral side effects of antiepileptic drugs. Available at: https://www.uspharmacist.com/article/behavioral-side-effects-of-antiepileptic-drugs (accessed 29.10.2021).Guerrini R. Epilepsy in children. Lancet. 2006; 367 (9509): 499–524. https://doi.org/10.1016/S0140-6736(06)68182-8.Guerrini R. Epilepsy in children. Lancet. 2006; 367 (9509): 499–524. https://doi.org/10.1016/S0140-6736(06)68182-8.Park S.P., Kwon S.H. Cognitive effects of antiepileptic drugs. J Clin Neurol. 2008; 4 (3): 99–106. https://doi.org/10.3988/jcn.2008.4.3.99.Park S.P., Kwon S.H. Cognitive effects of antiepileptic drugs. J Clin Neurol. 2008; 4 (3): 99–106. https://doi.org/10.3988/jcn.2008.4.3.99.Hovinga C.A., Asato M.R., Manjunath R., et al. Association of non-adherence to antiepileptic drugs and seizures, quality of life, and productivity: survey of patients with epilepsy and physicians. Epilepsy Behav. 2008; 13 (2): 316–22. https://doi.org/10.1016/j.yebeh.2008.03.009.Hovinga C.A., Asato M.R., Manjunath R., et al. Association of non-adherence to antiepileptic drugs and seizures, quality of life, and productivity: survey of patients with epilepsy and physicians. Epilepsy Behav. 2008; 13 (2): 316–22. https://doi.org/10.1016/j.yebeh.2008.03.009.Shetty J., Greene S.A., Mesalles-Naranjo O., Kirkpatrick M. Adherence to antiepileptic drugs in children with epilepsy in a Scottish population cohort. Dev Med Child Neurol. 2016; 58 (5): 469–74. https://doi.org/10.1111/dmcn.12942.Shetty J., Greene S.A., Mesalles-Naranjo O., Kirkpatrick M. Adherence to antiepileptic drugs in children with epilepsy in a Scottish population cohort. Dev Med Child Neurol. 2016; 58 (5): 469–74. https://doi.org/10.1111/dmcn.12942.Mellish L.C., Dunkley C., Ferrie C.D., Pal D.K. Antiepileptic drug treatment of rolandic epilepsy and Panayiotopoulos syndrome: clinical practice survey and clinical trial feasibility. Arch Dis Child. 2015; 100 (1): 62–7. https://doi.org/10.1136/archdischild-2013-304211.Mellish L.C., Dunkley C., Ferrie C.D., Pal D.K. Antiepileptic drug treatment of rolandic epilepsy and Panayiotopoulos syndrome: clinical practice survey and clinical trial feasibility. Arch Dis Child. 2015; 100 (1): 62–7. https://doi.org/10.1136/archdischild-2013-304211.Wheless J.W., Clarke D.F., Carpenter D. Treatment of pediatric epilepsy: expert opinion, 2005. J Child Neurol. 2005; 20 (Suppl. 1): S1–56. https://doi.org/10.1177/088307380502000101.Wheless J.W., Clarke D.F., Carpenter D. Treatment of pediatric epilepsy: expert opinion, 2005. J Child Neurol. 2005; 20 (Suppl. 1): S1–56. https://doi.org/10.1177/088307380502000101.Burneo J.G., McLachlan R.S. Treating newly diagnosed epilepsy: the Canadian choice. Can J Neurol Sci. 2007; 34 (2): 230–6. https://doi.org/10.1017/s0317167100006107.Burneo J.G., McLachlan R.S. Treating newly diagnosed epilepsy: the Canadian choice. Can J Neurol Sci. 2007; 34 (2): 230–6. https://doi.org/10.1017/s0317167100006107.Hill D.S., Wlodarczyk B.J., Palacios A.M., Finnel R.H. Teratogenic effects of antiepileptic drugs. Expert Rev Neurother. 2010; 10 (6): 943–59. https://doi.org/10.1586/ern.10.57.Hill D.S., Wlodarczyk B.J., Palacios A.M., Finnel R.H. Teratogenic effects of antiepileptic drugs. Expert Rev Neurother. 2010; 10 (6): 943–59. https://doi.org/10.1586/ern.10.57.European Medicines Agency. Reflection paper on the use of extrapolation in the development of medicines for paediatrics. 9 October 2017. URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/10/WC500236640.pdf.2017 (дата обращения 29.10.2021).European Medicines Agency. Reflection paper on the use of extrapolation in the development of medicines for paediatrics. 9 October 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/10/WC500236640.pdf.2017 (accessed 29.10.2021).Murphy D. Extrapolation of efficacy in the pediatric population. URL: https://www.fda.gov/media/85058/download (дата обращения 29.10.2021).Murphy D. Extrapolation of efficacy in the pediatric population. Available at: https://www.fda.gov/media/85058/download (accessed 29.10.2021).Brodie M.J. Sodium channel blockers in the treatment of epilepsy. CNS Drugs. 2017; 31 (7): 527–34. https://doi.org/10.1007/s40263-017-0441-0.Brodie M.J. Sodium channel blockers in the treatment of epilepsy. CNS Drugs. 2017; 31 (7): 527–34. https://doi.org/10.1007/s40263-017-0441-0.Rogawski M.A., Tofighy A., White H.S., et al. Current understanding of the mechanism of action of the antiepileptic drug lacosamide. Epilepsy Res. 2015; 110: 189–205. https://doi.org/10.1016/j.eplepsyres.2014.11.021.Rogawski M.A., Tofighy A., White H.S., et al. Current understanding of the mechanism of action of the antiepileptic drug lacosamide. Epilepsy Res. 2015; 110: 189–205. https://doi.org/10.1016/j.eplepsyres.2014.11.021.Инструкция по медицинскому применению лекарственного препарата Вимпат® (раствор для применения внутрь). ЛП-007034-210521. URL: http://grls.rosminzdrav.ru/ (дата обращения 29.10.2021).Instructions for medical use of the drug Vimpat® (solution for oral use). LP-007034-210521. Available at: http://grls.rosminzdrav.ru/ (in Russ.) (accessed 29.10.2021).Распоряжение Правительства РФ от 12 октября 2019 г. № 2406-р «Об утверждении перечня жизненно необходимых и важнейших лекарственных препаратов для медицинского применения на 2020 год, перечня лекарственных препаратов для медицинского применения, в том числе лекарственных препаратов для медицинского применения, назначаемых по решению врачебных комиссий медицинских организаций, перечня лекарственных препаратов, предназначенных для обеспечения лиц, больных гемофилией, муковисцидозом, гипофизарным нанизмом, болезнью Гоше, а также минимального ассортимента лекарственных препаратов, необходимых для оказания медицинской помощи». URL: https://www.garant.ru/products/ipo/prime/doc/72761778/(дата обращения 29.10.2021).Decree of the Government of the Russian Federation of October 12 , 2019 No. 2406-r “On approval of the List of Vital and Essential Medicines for medical use for 2020, the List of medicines for medical use, including medicines for medical use prescribed by decision of medical commissions of medical organizations, the List of medicines intended to provide persons with hemophilia, cystic fibrosis, pituitary nanism, Gaucher disease, as well as the minimum range of medicines necessary for medical care”. Available at: https://www.garant.ru/products/ipo/prime/doc/72761778/ (in Russ.) (accessed 29.10.2021).Сайт Министерства здравоохранения Российской Федерации. URL: http://www.rosminzdrav.ru/ministry/ (дата обращения 29.10.2021).Website of the Ministry of Health of the Russian Federation. Available at: http://www.rosminzdrav.ru/ministry/ (in Russ.) (accessed 29.10.2021).Farkas V., Steinborn B., Flamini J.R., et al. Efficacy and tolerability of adjunctive lacosamide in pediatric patients with focal seizures. Neurology. 2019; 93 (12): e1212–26. https://doi.org/10.1212/WNL.0000000000008126.Farkas V., Steinborn B., Flamini J.R., et al. Efficacy and tolerability of adjunctive lacosamide in pediatric patients with focal seizures. Neurology. 2019; 93 (12): e1212–26. https://doi.org/10.1212/WNL.0000000000008126.European Medicines Agency. Concept paper on extrapolation of efficacy and safety in medicine development. 22 June 2012. URL: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-extrapolation-efficacy-safety-medicinedevelopment_en.pdf (дата обращения 29.10.2021).European Medicines Agency. Concept paper on extrapolation of efficacy and safety in medicine development. 22 June 2012. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-extrapolation-efficacy-safety-medicinedevelopment_en.pdf (accessed 29.10.2021).Baulac M., Byrnes W., Williams P., et al. Lacosamide and sodium channel-blocking antiepileptic drug cross-titration against levetiracetam background therapy. Acta Neurol Scand. 2017; 135 (4): 434–41. https://doi.org/10.1111/ane.12691.Baulac M., Byrnes W., Williams P., et al. Lacosamide and sodium channel-blocking antiepileptic drug cross-titration against levetiracetam background therapy. Acta Neurol Scand. 2017; 135 (4): 434–41. https://doi.org/10.1111/ane.12691

The authors declare that there are no conflicts of interest present.