Abstract Details

Title Consistent and Durable Long-Term Efficacy from Two Open-Label Studies of Cenobamate

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 006

Objective Compare long-term efficacy of cenobamate for partial-onset (focal) seizures from the open-label extension (OLE) of a phase 2 study (YKP3089C017 [C017]) and from a post-hoc analysis of patients enrolled at 10 North American sites in a subsequent open-label phase 3 safety study (YKP3089C021 [C021]).

Background In two adequate and well-controlled phase 2 studies of up to 18 weeks, cenobamate 100 mg/day, 200 mg/day, and 400 mg/day provided significantly better partial seizure reduction vs placebo.

Design/Methods In C017, patients entered the OLE after a 2-week conversion to a target dose of 300 mg once daily (max dose 400 mg/day). In C021, patients initiated cenobamate at 12.5 mg/day, titrated every other week over 10 weeks to a target dose of 200 mg/day. Increases to 400 mg/day by 50-mg/day increments every other week were allowed.

Results N=354 patients had at least 4 seizures/28 days at baseline (median 9.5 seizures/28 days) and entered the C017 OLE; 213 (60.2%) received cenobamate for at least 48 months. During Months 42-48 in the OLE, the median percent reduction in 28-day seizure frequency was 76.1%; 100% and 50% responder rates were 23.0% and 77.0%, respectively. Of the 240 patients assessed from 10 sites in North America, 90 had at least 3 seizures/28 days at baseline (median ~8.5 seizures/28 days) and took cenobamate for at least 21 months. During Months 21-27 the 100% and 50% responder rates were 28.9% and 81.1%, respectively. The median percent reduction in 28-day seizure frequency was 84.8% during this time period.

Conclusions

Long-term efficacy results, including 50% and 100% responders, were reproducible and durable in two long-term open-label studies in patients with refractory focal seizures and were consistent with results from two shorter adequate and well-controlled studies.

Authors/Disclosures
William E. Rosenfeld, MD, F�鶹��ýӳ�� (Comprehensive Epilepsy Care Center for Children and Adults) PRESENTER	The institution of Dr. Rosenfeld has received personal compensation in the range of $500,000-$999,999 for serving as a Consultant for SK Life Science. Dr. Rosenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for SK Life Science.
Louis Ferrari (SK Lifescience)	Louis Ferrari has received personal compensation for serving as an employee of SK Life science.

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