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Abstract Details

Long-Term Efficacy of Cenobamate by Concomitant Antiseizure Medication: Post-hoc Analysis of the C017 Open-label Extension Study
Epilepsy/Clinical Neurophysiology (EEG)
Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)
024
To report long-term outcomes with adjunctive cenobamate by concomitant antiseizure medication (ASM) from the open-label extension (OLE) of the YKP3089C017 (C017) study.
Patients with uncontrolled focal epilepsy despite 1-3 ASMs achieved significantly greater reductions in median seizure frequency/month with adjunctive cenobamate (100, 200, or 400 mg/day) over placebo. Patients completing the double-blind period could continue in the OLE.
Patients entering the OLE underwent a 2-week blinded conversion to a target dose of cenobamate 300 mg/day (max dose 400 mg/day). Median percent reduction in seizure frequency/28 days from baseline (double-blind study) was compared among patients taking regimens including concomitant levetiracetam, lamotrigine, or lacosamide at baseline.
354/437 randomized patients (81%) entered the OLE and had any OLE seizure data; 60.2% (213/354) remained on therapy through 4 years. Most patients (82.8% [293/354]) were taking 2-3 concomitant ASMs at baseline of the double-blind study; 156 (44.1%) were on levetiracetam, 119 (33.6%) on lamotrigine, and 61 (17.2%) on lacosamide. Median percent reduction from baseline during the first 6 months of treatment in the OLE was 65.4% for all patients and 65.4%, 59.0%, and 61.0% for levetiracetam, lamotrigine, and lacosamide-treated patients. Reduction in seizure frequency increased over the OLE, up to a median 76.1% at 42-48 months for all patients (n=213) and 75.5%, 72.0%, and 72.5% for patients taking levetiracetam (n=100), lamotrigine (n=66), and lacosamide (n=38), respectively. 100% responder rate (zero seizures) at Months 42-48 was 23.0% for all cenobamate patients and 20.0%, 19.7%, and 13.2% for levetiracetam, lamotrigine, and lacosamide-treated patients, respectively. Most common adverse events among levetiracetam, lamotrigine, and lacosamide-treated patients included dizziness (19.0%, 19.4%, 18.8%), somnolence (9.6%, 12.0%, 14.4%), fatigue (5.7%, 6.6%, 11.4%), and diplopia (6.8%, 11.1%, 10.9%).
Adjunctive treatment with cenobamate was associated with sustained long-term efficacy in patients taking regimens including levetiracetam, lamotrigine, or lacosamide at the beginning of the OLE.
Authors/Disclosures
Louis Ferrari (SK Lifescience)
PRESENTER 		Louis Ferrari has received personal compensation for serving as an employee of SK Life science.
William E. Rosenfeld, MD, FÂ鶹´«Ã½Ó³»­ (Comprehensive Epilepsy Care Center for Children and Adults) 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.