The results of the long-term, open-label extension (OLE) of a randomized, double-blind, placebo-controlled study of cenobamate (C013) have been published online by the journal Epilepsia.
The OLE enrolled 149 adult patients who completed the 12-week C013 study* and the median treatment duration was 6.25 years.
The results showed the probability of continuing cenobamate for 6 years was 59%; among those who remained on cenobamate for at least 12 months, the probability of continuing for 6 years was 79%.
In conclusion, the study displayed high rates of retention and demonstrated that adjunctive cenobamate was generally safe and well-tolerated long-term.
The results were announced by SK Life Science, Inc., a subsidiary of SK biopharmaceuticals Co., Ltd., an innovative global pharmaceutical company focused on developing treatments for central nervous system (CNS) disorders.
*Study C013 is a multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of cenobamate 200 mg/day as an adjunctive therapy in adults (18-65 years old) with uncontrolled focal seizures.