Remarkably High Efficacy of Cenobamate in Adults With Focal-Onset Seizures: A Double-Blind, Randomized, Placebo-Controlled Trial
Abstract
Safety and Efficacy of Adjunctive Cenobamate (YKP3089) in Patients With Uncontrolled Focal Seizures: A Multicentre, Double-Blind, Randomized, Placebo-Controlled, Dose-Responsive Trial Krauss GL, Klein P, Brandt C, et al. Lancet Neurol. 2020;19(1):38-48. https://doi.org/10.1016/S1474-4422(19)30399-0. 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. METHODS: We did a multicenter, double-blind, randomized, placebo-controlled, dose–response study at 107 epilepsy and neurology centers in 16 countries. Adult patients (aged 18-70 years) with focal seizures despite treatment with 1 to 3 antiepileptic drugs were randomly assigned (1:1:1:1) via an interactive web response system, by block sizes of 4 within each country, to adjuvant once daily oral cenobamate at dose groups of 100 mg, 200 mg, or 400 mg, or placebo following an 8-week baseline assessment. Patients, investigators, and study personnel were masked to treatment assignment. The study included a 6-week titration phase and 12-week maintenance phase. The primary efficacy outcomes were percentage change in 28-day focal seizure…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 111 participants or records.
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