Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial

This study is registered with ClinicalTrials.gov, number NCT01866111.FindingsBetween July 31, 2013, and June 22, 2015, 437 patients were randomly assigned to either placebo (n=108) or cenobamate 100 mg (n=108), 200 mg (n=110), or 400 mg (n=111). Of these patients, 434 (106 [98%] in placebo group, 108 [100%] in 100 mg group, 109 [99%] in 200 mg group, and 111 [100%] in 400 mg group) were included in the modified intention-to-treat population, and 397 (102 [94%] in placebo group, 102 [94%] in 100 mg group, 98 [89%] in 200 mg group, and 95 [86%] in 400 mg group) were included in the modified intention-to-treat maintenance phase population. Median percentage changes in seizure frequency were −24·0% (IQR −45·0 to −7·0%) for the placebo group compared with −35·5% (−62·5 to −15·0%; p=0·0071) for the 100 mg dose group, −55·0% (−73·0 to −23·0%; p<0·0001) for the 200 mg dose group, and −55·0% (−85·0 to −28·0%; p<0·0001) for the 400 mg dose group. Responder rates during the maintenance phase were 25% (26 of 102 patients) for the placebo group compared with 40% (41 of 102; odds ratio 1·97, 95% CI 1·08–3·56; p=0·0365) for the 100 mg dose group, 56% (55 of 98; 3·74, 2·06–6·80; p<0·0001) for the 200 mg dose group, and 64% (61 of 95; 5·24, 2·84–9·67; p<0·0001) for the 400 mg dose group. Treatment-emergent adverse events occurred in 76 (70%) of 108 patients in the placebo group, 70 (65%) of 108 in the 100 mg group, 84 (7...
Source: The Lancet Neurology - Category: Neurology Source Type: research