Perampanel as monotherapy and adjunctive therapy for focal onset seizures, focal to bilateral tonic-clonic seizures and as adjunctive therapy of generalized onset tonic-clonic seizures

References

• World Health Organization, Informatics on epilepsy: 2016–2017; [ cited 2017 Jul 4]. Available from:http://www.who.int/mediacentre/informatic/mental-health/epilepsy/en
   Google Scholar
• Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000;342:314–319.
   PubMed Web of Science ®Google Scholar
• Brodie MJ, Barry SJE, Bamagous GA, et al. Patterns of treatment response in newly diagnosed epilepsy. Neurology. 2012;78:1548–1554.
   PubMed Web of Science ®Google Scholar
• Satlin A, Kramer LD, Laurenza A. Development of perampanel in epilepsy. Acta Neurol Scand. 2013;127:3–8.
   Web of Science ®Google Scholar
• Rogawski MA, Löscher W. The neurobiology of antiepileptic drugs. Nat Rev Neurosci. 2004;5:553–564.
   PubMed Web of Science ®Google Scholar
• Namba T, Morimoto K, Sato K, et al. Antiepileptogenic and anticonvulsant effects of NBQX, a selective AMPA receptor antagonist, in the rat kindling model of epilepsy. Brain Res. 1994;638:36–44.
   PubMed Web of Science ®Google Scholar
• Rogawski MA, Donevan SD. AMPA receptors in epilepsy and as targets for antiepileptic drugs. Adv Neurol. 1999;79:947–963.
   PubMedGoogle Scholar
• Tortorella A, Halonen T, Sahibzada N, et al. A crucial role of the amino-3-hydroxy-5-methylisoxazole-4-propionic acid subtype of glutamate receptors in piriform and perirhinal cortex for the initiation and propagation of limbic motor seizures. J Pharmacol Exp Ther. 2018;280:5.
   Google Scholar
• Rogawski MA, Hanada T. Preclinical pharmacology of perampanel, a selective non-competitive AMPA receptor antagonist. Acta Neurol Scand Suppl. 2013;197:19–24.
   PubMedGoogle Scholar
• Hanada T, Hashizume Y, Tokuhara N, et al. Perampanel: a novel, orally active, noncompetitive AMPA-receptor antagonist that reduces seizure activity in rodent models of epilepsy. Epilepsia. 2011;52:1331–1340.
   PubMed Web of Science ®Google Scholar
• Ceolin L, Bortolotto ZA, Bannister N, et al. A novel anti-epileptic agent, perampanel, selectively inhibits AMPA receptor-mediated synaptic transmission in the hippocampus. Neurochem Int. 2012;61:517–522.
   PubMed Web of Science ®Google Scholar
• Löscher W. Animal models of epilepsy for the development of antiepileptogenic and disease-modifying drugs. A comparison of the pharmacology of kindling and post-status epilepticus models of temporal lobe epilepsy. Epilepsy Res. 2002;50:105–123.
   PubMed Web of Science ®Google Scholar
• Patsalos PN. The clinical pharmacology profile of the new antiepileptic drug perampanel: a novel noncompetitive AMPA receptor antagonist. Epilepsia. 2015;56:12–27.
   PubMed Web of Science ®Google Scholar
• Franco V, Crema F, Iudice A, et al. Novel treatment options for epilepsy: focus on perampanel. Pharmacol Res. 2013;70:35–40.
   PubMed Web of Science ®Google Scholar
• Majid O, Laurenza A, Ferry J, et al. Impact of perampanel on pharmacokinetics of concomitant antiepileptics in patients with partial‐onset seizures: pooled analysis of clinical trials. Br J Clin Pharmacol. 2016;82:422–430.
   PubMed Web of Science ®Google Scholar
• Krauss GL, Bar M, Biton V, et al. Tolerability and safety of perampanel: two randomized dose-escalation studies. Acta Neurol Scand. 2012;125:8–15.
   PubMed Web of Science ®Google Scholar
• French JA, Krauss GL, Biton V, et al. Adjunctive perampanel for refractory partial-onset seizures randomized phase III study 304. Neurology. 2012;79:589–596.
   PubMed Web of Science ®Google Scholar
• 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;54:117–125.
   PubMed Web of Science ®Google Scholar
• Krauss GL, Serratosa JM, Villanueva V, et al. Randomized phase III study 306 adjunctive perampanel for refractory partial-onset seizures. Neurology. 2012;78:1408–1415.
   PubMed Web of Science ®Google Scholar
• Steinhoff BJ, Ben-Menachem E, Ryvlin P, et al. Efficacy and safety of adjunctive perampanel for the treatment of refractory partial seizures: a pooled analysis of three phase III studies. Epilepsia. 2013;54:1481–1489.
   PubMed Web of Science ®Google Scholar
• Rugg-Gunn F. Adverse effects and safety profile of perampanel: a review of pooled data. Epilepsia. 2014;55:13–15.
   PubMed Web of Science ®Google Scholar
• Ko D, Ramsay RE. Perampanel: expanding therapeutic options for patients with medically refractory secondary generalized convulsive seizures. Acta Neurol Scand Supplementum. 2013;127:36–43.
   Google Scholar
• Rektor I, Krauss GL, Bar M, et al. Perampanel study 207: long-term open-label evaluation in patients with epilepsy. Acta Neurol Scand. 2012;126:263–269.
   PubMed Web of Science ®Google Scholar
• Krauss GL, Perucca E, Ben-Menachem E, et al. Perampanel, a selective, noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor antagonist, as adjunctive therapy for refractory partial-onset seizures: interim results from phase III, extension study 307. Epilepsia. 2013;54:126–134.
   PubMed Web of Science ®Google Scholar
• 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;59:866–876.
   PubMed Web of Science ®Google Scholar
• Kwan P, Mintzer S, Laurenza A, et al. Evaluation of perampanel as monotherapy for focal seizures: experience from open-label extension studies. Epilepsy Behav Case Rep. 2018;9:1–5.
   PubMed Web of Science ®Google Scholar
• French JA, Krauss GL, Wechsler RT, et al. Perampanel for tonic-clonic seizures in idiopathic generalized epilepsy. A randomized trial. Neurology. 2015;85:950–957.
   PubMed Web of Science ®Google Scholar
• Wechsler RT, French J, Trinka E, et al. Long-term safety and efficacy outcomes of adjunctive perampanel: an open-label extension (OLEx) of a Phase III study in patients with drug-resistant primary generalized tonic-clonic (PGTC) seizures in idiopathic generalized epilepsy (IGE) (P5–P233). Neurology. 2017;88:P5–P233.
   Google Scholar
• O’Brien T, Bibbiani F, Patten A, et al. Effect of common concomitant antiepileptic drugs (AEDs) during adjunctive treatment with perampanel: post hoc analysis from the open-label extension (OLEx) of a phase III study in patients with idiopathic generalized epilepsy (IGE) (P1.261). Neurology. 2018;90:P1–P261.
   Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Kramer LD, Satlin A, Krauss GL, et al. Perampanel for adjunctive treatment of partial-onset seizures: a pooled dose–response analysis of phase III studies. Epilepsia. 2014;55:423–431.
   PubMed Web of Science ®Google Scholar
• Rohracher A, Zimmermann G, Villanueva V, et al. Perampanel in routine clinical use across Europe: pooled, multicenter, observational data. Epilepsia. 2018;59:1727–1739.
   PubMed Web of Science ®Google Scholar
• Schorlemmer K, Bauer S, Belke M, et al. Sustained seizure remission on perampanel in progressive myoclonic epilepsy (Lafora disease). Epilepsy Behav Case Rep. 2013 Aug;16(1):118–121.
   Google Scholar
• Goldsmith D, Minassian BA. Efficacy and tolerability of perampanel in ten patients with Lafora disease. Epilepsy Behav. 2016 Sep;1(62):132–135.
   Google Scholar
• Hu S-C, Hung K-L, Chen H-J, et al. Seizure remission and improvement of neurological function in sialidosis with perampanel therapy. Epilepsy Behav Case Rep. 2018;10:32–34.
   PubMed Web of Science ®Google Scholar
• Shiraishi H, Egawa K, Ito T, et al. Efficacy of perampanel for controlling seizures and improving neurological dysfunction in a patient with dentatorubral-pallidoluysian atrophy (DRPLA). Epilepsy Behav Case Rep. 2017;8:44–46.
   PubMed Web of Science ®Google Scholar
• Steinhoff BJ. Adjunctive perampanel for partial-onset seizures. Acta Neurol Scand. 2018 Apr;1(137):376–377.
   Google Scholar
• Mintzer S, French JA, Perucca E, et al. Is a separate monotherapy indication warranted for antiepileptic drugs?. Lancet Neurol. 2015;14:1229–1240.
   PubMed Web of Science ®Google Scholar
• Faulkner MA. Spotlight on perampanel in the management of seizures: design, development and an update on place in therapy. Drug Des Devel Ther. 2017 Oct;4(11):2921–2930.
   Google Scholar
• Rudzinski LA, Vélez-Ruiz NJ, Gedzelman ER, et al. New antiepileptic drugs: focus on ezogabine, clobazam, and perampanel. J Invest Med. London. 2016 Aug;64:1087.
   PubMed Web of Science ®Google Scholar
• Diaz A, Deliz B, Benbadis SR. The use of newer antiepileptic drugs in patients with renal failure. Expert Rev Neurother. 2012 Jan;12:99–105.
   PubMed Web of Science ®Google Scholar
• Mora Rodríguez KA, Benbadis SR. Managing antiepileptic medication in dialysis patients. Curr Treat Options Neurol. 2018 Sep;27(20):45.
   Google Scholar
• Greenwood J, Valdes J. Perampanel (Fycompa). P T. 2016 Nov;41:683–698.
   PubMedGoogle Scholar
• Brigo F, Bragazzi NL, Nardone R, et al. Efficacy and tolerability of brivaracetam compared to lacosamide, eslicarbazepine acetate, and perampanel as adjunctive treatments in uncontrolled focal epilepsy: results of an indirect comparison meta-analysis of RCTs. Seizure. 2016;42:29–37.
   PubMed Web of Science ®Google Scholar
• Hu Q, Zhang F, Teng W, et al. Efficacy and safety of antiepileptic drugs for refractory partial-onset epilepsy: a network meta-analysis. J Neurol. 2018;265:1–11.
   PubMed Web of Science ®Google Scholar
• Mula M. Third generation antiepileptic drug monotherapies in adults with epilepsy. Expert Rev Neurother. 2016;16:1087–1092.
   PubMed Web of Science ®Google Scholar
• Margolis JM, Chu BC, Wang ZJ, et al. Effectiveness of antiepileptic drug combination therapy for partial-onset seizures based on mechanisms of action. JAMA Neurol. 2014;71:985–993.
   PubMed Web of Science ®Google Scholar
• Fycompa (perampanel) prescribing information. Woodcliff Lake. New Jersey: Eisai R&D Management (Eisai Ltd.); 2016.
   Google Scholar
• Ettinger AB, LoPresti A, Yang H, et al. Psychiatric and behavioral adverse events in randomized clinical studies of the noncompetitive AMPA receptor antagonist perampanel - Ettinger - 2015 - Epilepsia - Wiley Online Library. Epilepsia. 2015;56:1252–1263.
   PubMed Web of Science ®Google Scholar
• Zaccara G, Giovannelli F, Cincotta M, et al. The adverse event profile of perampanel: meta-analysis of randomized controlled trials. Eur J Neurol. 2013;20:1204–1211.
   PubMed Web of Science ®Google Scholar
• Nikanorova M, Biro A, Kölmel M, et al. Perampanel efficacy and safety in severe epileptic encephalopathies of childhood. Epilepsia. 2015;56:173.
   PubMed Web of Science ®Google Scholar
• Rosenfeld W, Conry J, Lagae L, et al. Efficacy and safety of perampanel in adolescent patients with drug-resistant partial seizures in three double-blind, placebo-controlled, phase III randomized clinical studies and a combined extension study. Eur J Paediatr Neurol. 2015;19:435–445.
   PubMed Web of Science ®Google Scholar
• Biró A, Stephani U, Tarallo T, et al. Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies: first experiences. Neuropediatrics. 2015 Mar;2(46):110–115.
   Google Scholar
• De Liso P, Vigevano 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.
   PubMed Web of Science ®Google Scholar
• Lin K-L, Lin -J-J, Chou M-L, 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 Aug;1(85):188–194.
   Google Scholar
• 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 Nov;1(52):63–70.
   Google Scholar
• Auvin S, Dozieres B, Ilea A, et al. Use of perampanel in children and adolescents with Lennox–Gastaut syndrome. Epilepsy Behav. 2017 Sep;1(74):59–63.
   Google Scholar