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Abstract Details

Safety of Cenobamate for the Treatment of Focal Seizures, Following 1-Week vs 2-Week Titration Schedules
Epilepsy/Clinical Neurophysiology (EEG)
P11 - Poster Session 11 (8:00 AM-9:00 AM)
12-011
To assess safety of cenobamate in patients with uncontrolled focal seizures when titrated weekly (1W) or every other week (2W).
Treatment-emergent adverse event (TEAE) and exposure data from clinical studies YKP3089C013 (C013), YKP3089C017 (C017), and YKP3089C021 (C021) were analyzed.
In C013, starting doses of 50mg/day were increased by 50 mg/day every 2 weeks to 200 mg/day. In C017, patients were randomized to cenobamate 100, 200, or 400 mg/day. Cenobamate was increased at weekly intervals (50, 100, 150, 200, 300, 400 mg/day). In C021, cenobamate was increased at 2-week intervals (12.5, 25, 50, 100, 150, and 200 mg/day) to 200 mg/day. The dose could then be increased by 50mg/day every 2 weeks to a maximum of 400 mg/day. TEAEs, discontinuations due to TEAEs, and serious TEAEs were compared between pooled C013 and C021 (2W) data and C017 (1W) data.
Fewer patients had ≥1 treatment-related TEAE in the 2W (70.0%) vs 1W (83.8%) group, fewer patients reported ≥1 serious TEAE in the 2W (9.6%) vs 1W group (20.5%), and fewer 2W patients discontinued due to a TEAE (11%) vs the 1W group (19.3%). The most common TEAEs leading to discontinuation were dizziness (2W, 1.0%; 1W, 2.4%), somnolence (2W, 0.6%; 1W, 1.9%), and ataxia (2W, 0.4%; 1W, 1.9%). Severe TEAEs were experienced by fewer 2W vs 1W patients; the most common were dizziness (2W, 0.9%; 1W, 4.8%), somnolence (2W, 0.4%; 1W, 3.6%), and vertigo (2W, 0%; 1W, 1.7%). One 1W patient (200 mg/day) experienced drug reaction with eosinophilia and systemic symptoms (DRESS) on Day 24.
A slower, 2-week titration schedule was better tolerated than a 1-week titration. Fewer 2W vs 1W patients experienced treatment-related TEAEs, discontinuations due to TEAEs, and serious and severe TEAEs, particularly vertigo, somnolence, and dizziness. No cases of DRESS were identified in 2W group.
Authors/Disclosures
Marc Kamin, MD
PRESENTER 		Dr. Kamin has received personal compensation for serving as an employee of SK LIFE SCIENCE INC.
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.
Louis Ferrari (SK Lifescience) Louis Ferrari has received personal compensation for serving as an employee of SK Life science.