Tolerability and efficacy of adjunctive lacosamide in children and adolescents with focal seizures in context of presence or absence of sodium-channel blocking AEDs: Post-hoc analysis of a randomized, double-blind, placebo-controlled trial

Objective: To investigate the tolerability and efficacy of lacosamide (LCM) in children and adolescents with focal seizures with or without concomitant sodium-channel blocking (SCB) AEDs. Background: Data in adults revealed inconsistent findings on the tolerability and efficacy of LCM with or without SCB AEDs. Design/Methods This was a post-hoc analysis of a double-blind, placebo (PBO)-controlled trial (SP0969; NCT01921205) of adjunctive LCM in patients (≥4– Results: 343 patients received trial medication (SS); 65.3% (LCM/PBO:116/108) on SCB[+] and 34.7% (LCM/PBO:55/64) on SCB[−]. Overall incidence of treatment-emergent adverse events (TEAEs) during the Treatment Period (LCM/PBO): 63.8%/59.3% on SCB[+], 76.4%/56.3% on SCB[−]; drug-related TEAEs (LCM/PBO): 34.5%/16.7% on SCB[+], 25.5%/20.3% on SCB[−]; discontinuations due to TEAEs (LCM/PBO): 5.2%/6.5% on SCB[+], 1.8%/4.7% on SCB[−]. From Baseline to Maintenance, percent seizure reduction on LCM vs PBO (FAS) in focal seizure-frequency/28 days: 31.4% on SCB[+] (LCM n=115; PBO n=106), 32.4% on SCB[−] (LCM n=55; PBO n=62); median percent reduction in seizure-frequency/28 days (LCM/PBO): 55.4%/24.8% on SCB[+], 51.7%/20.0% on SCB[−]; 50% responder rate (LCM/PBO): 53.0%/34.0% on SCB[+], 52.7%/32.3% on [SCB[−]; 75% responder rate (LCM/PBO): 29.6%/17.0% on SCB[+], 34.5%/14.5% on SCB[−]. Conclusions: This post-hoc analysis shows that in children and adolescents (≥4– Study Supported by: UCB Pharma. Disclosure: Dr. Scheffer has nothing to disclose. Dr. Bozorg has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of UCB Pharma. Dr. Bozorg holds stock and/or stock options in UCB. Dr. Daniels has nothing to disclose. Dr. Zhang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Full time employee of UCB Pharma. Dr. Zhang holds stock and/or stock options in Stock options of UCB Pharma, and is a full time employee of UCB Pharma, which sponsored research in which Dr. Zhang was involved as an investigator. Dr. Zhang holds stock and/or stock options in Stock options of UCB Pharma, and is a full time employee of UCB Pharma. Dr. Yuen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of UCB Pharma. Dr. Dimova has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Full time employee of UCB Pharma. Dr. Dimova holds stock and/or stock options in Stock options of UCB Pharma, and is a full time employee of UCB Pharma, which sponsored research in which Dr. Dimova was involved as an investigator. Dr. Dimova holds stock and/or stock options in Stock options of UCB Pharma, and is a full time employee of UCB Pharma.