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Abstract Details

Post-hoc Analysis of a Phase 3, Open-Label Study of Cenobamate for Treatment of Uncontrolled Focal Seizures: Effects of Dose Reductions to Concomitant Lamotrigine and Carbamazepine
Epilepsy/Clinical Neurophysiology (EEG)
Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)
011
Report post-hoc results of how dose adjustments to concomitant lamotrigine and carbamazepine impacted efficacy and tolerability in an ongoing, phase 3 study (N=1347) of cenobamate, an FDA-approved antiseizure medication (ASM) for treatment of focal seizures.
Adjunctive cenobamate may reduce plasma levels of concomitant lamotrigine and carbamazepine, thus dose adjustments to these may be considered. 
Patients with uncontrolled focal seizures on 1-3 ASMs were enrolled. Increasing doses of cenobamate were administered (12.5, 25, 50, 100, 150, 200 mg/day) biweekly. Increases to 400 mg/day by 50-mg/day increments biweekly and adjustments to concomitant ASMs were permitted. 
Of 240 patients, 177 (73.8%) remained on cenobamate. At baseline, 66 (27.5%) and 24 (10.0%) were on concomitant lamotrigine and carbamazepine. Among ongoing cenobamate patients who received these ASMs, 28/48 (58.3%) lamotrigine and 11/16 (68.8%) carbamazepine patients had their ASM dose reduced. Ongoing cenobamate patients had greater dose reductions of carbamazepine and approximately equal reductions of lamotrigine vs those who discontinued. Among ongoing cenobamate patients, lamotrigine and carbamazepine were discontinued in n=7 (14.5%) and n=5 (31.3%) patients. Lamotrigine and carbamazepine reductions occurred most due to adverse events of fatigue and dizziness. 60/177 (33.9%) cenobamate patients were seizure-free for ≥12 months at last 3-month visit and 17/60 (28.3%) received lamotrigine. This was similar to percentages on lamotrigine of all patients (27.5%), those continuing cenobamate (27.1%), and those who discontinued cenobamate (28.6%). Fewer carbamazepine patients were seizure-free at 5.0% (3/60) vs 10.0% (24/240) of all evaluable, 9.0% (16/177) of ongoing cenobamate patients, and 12.7% (8/63) of those who discontinued cenobamate.
In this analysis, greater reductions of carbamazepine led to more patients continuing cenobamate and lamotrigine reductions were approximately equal among ongoing and discontinued patients. Despite data indicating increasing doses of concomitant lamotrigine and carbamazepine be considered with cenobamate, ASMs doses were reduced and negative changes in efficacy were infrequent.
Authors/Disclosures
Louis Ferrari (SK Lifescience)
PRESENTER 		Louis Ferrari has received personal compensation for serving as an employee of SK Life science.
Arkady Nisman, PharmD (SK Life Science, Inc.) Dr. Nisman has received personal compensation for serving as an employee of SK Life Science, Inc.. Dr. Nisman has a non-compensated relationship as a Senior Director, Medical Affairs with SK Life Science, Inc. that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
Michael R. Sperling, MD, FÂ鶹´«Ã½Ó³»­ (Thomas Jefferson University) Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. The institution of Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB Pharma. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medscape. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for International Medical Press. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Projects for Knowledge. The institution of Dr. Sperling has received research support from SK Life Science. The institution of Dr. Sperling has received research support from UCB Pharma . The institution of Dr. Sperling has received research support from Takeda. The institution of Dr. Sperling has received research support from Neurelis. The institution of Dr. Sperling has received research support from Engage Therapeutics . The institution of Dr. Sperling has received research support from Medtronic. The institution of Dr. Sperling has received research support from Cavion. The institution of Dr. Sperling has received research support from Xenon Pharma. The institution of Dr. Sperling has received research support from Cerevel. The institution of Dr. Sperling has received research support from National Institutes of Health . The institution of Dr. Sperling has received research support from DARPA. Dr. Sperling has received publishing royalties from a publication relating to health care. Dr. Sperling has received publishing royalties from a publication relating to health care. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Vice President with Epilepsy Consortium .
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.