Long-Term Efficacy and Safety of Adjunctive Cenobamate in Patients with Uncontrolled Focal Seizures: Open-Label Extension of a Randomized Clinical Study
Abstract number :
2.206
Submission category :
7. Antiepileptic Drugs / 7B. Clinical Trials
Year :
2019
Submission ID :
2421651
Source :
www.aesnet.org
Presentation date :
12/8/2019 4:04:48 PM
Published date :
Nov 25, 2019, 12:14 PM
Authors :
Pavel Klein, Mid-Atlantic Epilepsy and Sleep center; Gregory L. Krauss, Johns Hopkins University School of Medic; Sami Aboumatar, Austin Epilepsy Care Center; Marc Kamin, SK Life Science, Inc.
Rationale: Results from a double-blind (DB), placebo-controlled, dose-response YKP3089C017 (C017) study demonstrated significant reductions in median percentage seizure frequency/month with cenobamate (CNB) 100, 200, and 400 mg (35.5%, 55.0%, and 55.0%, respectively) vs. placebo (PBO, 24.0%; all p<0.01). The most common treatment-emergent adverse events (TEAEs) with CNB during DB treatment were somnolence, dizziness, headache, and fatigue. Patients who completed the entire 18-week DB treatment period were eligible to continue CNB in an open-label extension (OLE). Here we report long-term efficacy outcomes (change in seizure frequency/month) and safety outcomes (adverse events) from the ongoing OLE. Methods: In C017, 437 adults 18-70 years old with uncontrolled focal seizures who had >
Antiepileptic Drugs