Efficacy and safety of extended-release oxcarbazepine (Oxtellar XR™) as adjunctive therapy in patients with refractory partial-onset seizures: a randomized controlled trial

Acta Neurologica Scandinavica
J A FrenchPROSPER Investigators Study Group

Abstract

To evaluate the efficacy, tolerability, and safety of once-daily 1200 mg and 2400 mg SPN-804 (Oxtellar XR™, Supernus Pharmaceuticals), an extended-release tablet formulation of oxcarbazepine (OXC), added to 1-3 concomitant antiepileptic drugs (AEDs) in adults with refractory partial-onset seizures, with or without secondary generalization. The Prospective, Randomized Study of OXC XR in Subjects with Partial Epilepsy Refractory (PROSPER) study was a multinational, randomized, double-blind, parallel-group Phase 3 study. The primary efficacy endpoint was median percent reduction from baseline in monthly (28-day) seizure frequency for the 16-week double-blind treatment period in the intent-to-treat (ITT) population with analyzable seizure data. Other efficacy analyses included proportion of patients with ≥ 50% seizure reduction, proportion of patients seizure free, and the relationship between clinical response and plasma concentration. Median percent reduction was -28.7% for placebo, -38.2% (P = 0.08 vs placebo) for once-daily SPN-804 1200 mg, and -42.9% (P = 0.003) for SPN-804 2400 mg. Responder rates were 28.1%, 36.1% (P = 0.08), and 40.7% (P = 0.02); 16-week seizure-free rates in a pragmatic ITT analysis were 3.3%, 4.9% (P = 0....Continue Reading

References

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Citations

Nov 28, 2015·Pharmacological Research : the Official Journal of the Italian Pharmacological Society·Valentina FrancoEmilio Perucca
Sep 13, 2015·Seizure : the Journal of the British Epilepsy Association·Annika SattlerTheodor W May
Mar 18, 2016·Current Neurology and Neuroscience Reports·Derek J Chong, Andrew M Lerman
Jun 19, 2014·Expert Opinion on Pharmacotherapy·Lorenza ChiossiPaolo Martelletti
Jul 23, 2016·Acta Neurologica Scandinavica·E SchmidE Trinka
Nov 20, 2015·Lancet Neurology·Scott MintzerMichel Baulac
Apr 20, 2018·Expert Opinion on Pharmacotherapy·Christian Brandt, Theodor W May
Jul 2, 2014·Electrophoresis·Mariana Zuccherato BocatoAnderson Rodrigo Moraes de Oliveira
Mar 5, 2020·The Cochrane Database of Systematic Reviews·Rebecca BresnahanAnthony G Marson
Dec 30, 2017·Expert Review of Clinical Pharmacology·Laurent M WillemsAdam Strzelczyk
Nov 30, 2018·Expert Opinion on Pharmacotherapy·Monika BanachStanisław J Czuczwar
Sep 16, 2014·Expert Review of Neurotherapeutics·Steve Chung
Dec 20, 2018·Epilepsia Open·Emilio Perucca
Jan 26, 2020·Seizure : the Journal of the British Epilepsy Association·Rodrigo RocamoraVicente Villanueva
Apr 15, 2021·Expert Review of Clinical Pharmacology·Yue-Ting ChenZheng Jiao
Jul 24, 2021·Neuropsychopharmacology Reports·Tahir Hakami

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