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Abstract Details

Seizure Reduction With Adjunctive Cenobamate During Titration in the Phase 3 C021 Study
Epilepsy/Clinical Neurophysiology (EEG)
Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)
022
Assess seizure reduction in cenobamate-treated patients during titration.
Cenobamate is approved in the US for treatment of focal (partial-onset) seizures in adults. The phase 3, open-label C021 study used start-low, go-slow cenobamate titration.
Adults with uncontrolled focal seizures taking 1-3 ASMs received adjunctive cenobamate 12.5 mg/day for 2 weeks, with increasing doses (25, 50, 100, 150, 200 mg/day) at 2-week intervals thereafter. Seizure reduction up to the 100 mg/day dose was evaluated post-hoc.
Two hundred forty patients from 10 eligible US study sites had seizure data, met inclusion criteria, and were included in the analysis population; 177 were still receiving cenobamate. In patients continuing cenobamate, the ≥50% responder rate increased from 52.6% with 12.5 mg/day (Weeks 1-2), 60.6% with 25 mg/day (Weeks 3-4), and 67.6% with 50 mg/day (Weeks 5-6) during titration. Sixty (33.9%) patients experienced 100% seizure reduction for ≥12 months. Among them, 100% seizure reduction occurred in 51.7% of patients at 12.5 mg/day (Weeks 1-2), 55.0% at 25 mg/day (Weeks 3-4), 73.3% at 50 mg/day (Weeks 5-6), and 65.0% at 100 mg/day (Weeks 7-8). The median percent reduction in 28-day seizure frequency in ongoing cenobamate patients was 65.1% with 12.5 mg/day (Weeks 1-2), 77.9% with 25 mg/day (Weeks 3-4), and 100% with 50 mg/day (Weeks 5-6). These results exceed the predicted reduction during titration based on FDA modeling. Common adverse events in ongoing cenobamate patients were fatigue, dizziness, and somnolence. No cases of DRESS occurred.
Patients with uncontrolled focal seizures who received adjunctive cenobamate with start-low, go-slow titration responded to cenobamate as early as the first 1-2 weeks of therapy with 12.5 mg/day. Early reduction appeared to be a good predictor of response. Patients without early reduction may also have a response as additional reduction, including 100% seizure reduction, occurred with continued increases in cenobamate dose during titration.
Authors/Disclosures
Victor Biton, MD (AEP)
PRESENTER 		Dr. Biton has nothing to disclose.
Perminder Bhatia, MD (Neuro-pain Medical Center Inc) Dr. Bhatia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BIOHAVEN. Dr. Bhatia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ALLERGAN. Dr. Bhatia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for SK LIFE SCIENCES.
Louis Ferrari (SK Lifescience) Louis Ferrari has received personal compensation for serving as an employee of SK Life science.
Mindy Grall, PhD, NP Ms. Grall has received personal compensation for serving as an employee of Supernus Pharmaceuticals. Ms. Grall has or had stock in Supernus.
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.