Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial
Article and commentary
10 March, 2020
The Lancet Neurology Volume 19, Issue 1, January 2020, pages 38-44
Summary
Background
More than a third of patients with epilepsy are treatment resistant, and thus new, more effective therapies to achieve seizure freedom are needed. Cenobamate (YKP3089), an investigational antiepileptic drug, has shown broad-spectrum anticonvulsant activity in preclinical studies and seizure models. We aimed to evaluate the safety, efficacy, and tolerability of adjunctive cenobamate in patients with uncontrolled focal (partial)-onset epilepsy.
Interpretation
Adjunctive cenobamate reduced focal (partial)-onset seizure frequency, in a dose-related fashion. Treatment-emergent adverse events were most frequent in the highest dose group. Cenobamate appears to be an effective treatment option in patients with uncontrolled focal seizures.
Commentary
Cenobamate for focal seizures — a game changer?
Nature Reviews Neurology 16, 133-134(2020)
In the first published efficacy study of cenobamate for treatment-resistant focal seizures, high doses produced high seizure-free rates, suggesting cenobamate can outperform existing options. A risk of serious rash and low tolerability at higher doses means further safety studies and clinical experience are needed to determine its clinical value.
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