Krauss and colleagues recently published the results of a trial of adjunctive treatment with cenobamate (YKP3089) for uncontrolled focal seizures. In this trial, 437 patients with focal seizures refractory to at least one antiepileptic drug were randomly assigned to placebo (n=108) or to three different adjunctive cenobamate dose groups (108 patients to 100 mg per day, 110 to 200 mg per day, and 111 to 400 mg per day). Of the 437 patients, 138 (32%) were taking lamotrigine, 122 (28%) were on carbamazepine, and 64 (15%) were taking oxcarbazepine. A large proportion of patients in this study had at least one treatment-emergent adverse event; 65% in the 100 mg cenobamate group, 76% in the 200 mg group, and 90% in the 400 mg group. The most frequent side-effects (in ≥10% of patients) were dizziness, somnolence, diplopia, headache, and fatigue. 53 (approximately 12%) patients (five taking placebo, 11 taking cenobamate 100 mg per day, 15 taking cenobamate 200 mg per day, and 22 taking cenobamate 400 mg per day) had to discontinue treatment because of intolerable side-effects. Common adverse events that led to cessation of the treatment were ataxia, dizziness, nystagmus, and vertigo.

中文翻译：

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未控制的局灶性癫痫发作中使用cenobamate辅助治疗的安全性。

克劳斯和他的同事们最近发表了一项实验结果，结果表明，使用考诺贝特（YKP3089）进行辅助治疗可治疗局灶性癫痫。在该试验中，将437例至少对一种抗癫痫药难治的局灶性癫痫发作患者随机分配至安慰剂组（n = 108）或三个不同的Cenobamate辅助剂量组（108例患者每天100 mg，每天110至200 mg，和每天111至400毫克）。在这437名患者中，有138名（32％）服用拉莫三嗪，有122名（28％）服用卡马西平，有64名（15％）服用奥卡西平。在这项研究中，很大一部分患者发生了至少一种治疗紧急事件。100 mg cenobamate组为65％，200 mg组为76％，400 mg组为90％。最常见的副作用（≥10％的患者）是头晕，嗜睡，复视，头痛和疲劳。53名（约12％）患者（5名服用安慰剂，11名每天服用cenobamate 200毫克，15名每天服用cenobamate 200毫克和22名每天服用cenobamate 400毫克）由于无法忍受的副作用而不得不中止治疗。导致停药的常见不良事件为共济失调，头晕，眼球震颤和眩晕。