好色先生

好色先生

Explore the latest content from across our publications
Join The AAN

Log In

Forgot Password?
Create New Account

Loading... please wait

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, FAAN (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.