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Title: Efficacy and tolerability of adjunctive lacosamide in pediatric patients with focal seizures.
Austin Authors: Farkas, Viktor;Steinborn, Barbara;Flamini, J Robert;Zhang, Ying;Yuen, Nancy;Borghs, Simon;Bozorg, Ali;Daniels, Tony;Martin, Paul;Carney, Hannah C;Dimova, Svetlana;Scheffer, Ingrid E 
Affiliation: Florey and Murdoch Children's Research Institute, University of Melbourne, Australia
UCB Pharma, Brussels, Belgium
Austin Health, Heidelberg, Victoria, Australia
First Department of Pediatrics, Semmelweis University, Budapest, Hungary
Department of Developmental Neurology, Poznań University of Medical Sciences, Poland
PANDA Neurology, Atlanta, GA, USA
UCB Pharma, Raleigh, NC, USA
UCB Pharma, Slough, UK
UCB Pharma, Braine-l'Alleud, Belgium
Evidence Scientific Solutions, Horsham, UK
Issue Date: 28-Aug-2019 2019-08-29
Publication information: Neurology 2019; 93(12): e1212-e1226
Abstract: To evaluate efficacy and tolerability of adjunctive lacosamide in children and adolescents with uncontrolled focal (partial-onset) seizures. In this double-blind trial (SP0969; NCT01921205), patients (age ≥4-<17 years) with uncontrolled focal seizures were randomized (1:1) to adjunctive lacosamide/placebo. After a 6-week titration, patients who reached the target dose range for their weight (<30 kg: 8-12 mg/kg/d oral solution; ≥30-<50 kg: 6-8 mg/kg/d oral solution; ≥50 kg: 300-400 mg/d tablets) entered a 10-week maintenance period. The primary outcome was change in focal seizure frequency per 28 days from baseline to maintenance. Three hundred forty-three patients were randomized; 306 (lacosamide 152 of 171 [88.9%]; placebo 154 of 172 [89.5%]) completed treatment (titration and maintenance). Adverse events (AEs) were the most common reasons for discontinuation during treatment (lacosamide 4.1%; placebo 5.8%). From baseline to maintenance, percent reduction in focal seizure frequency per 28 days for lacosamide (n = 170) vs placebo (n = 168) was 31.7% (p = 0.0003). During maintenance, median percent reduction in focal seizure frequency per 28 days was 51.7% for lacosamide and 21.7% for placebo. Fifty percent responder rates (≥50% reduction) were 52.9% and 33.3% (odds ratio 2.17, p = 0.0006). During treatment, treatment-emergent AEs were reported by 67.8% lacosamide-treated patients (placebo 58.1%), most commonly (≥10%) somnolence (14.0%, placebo 5.2%) and dizziness (10.5%, placebo 3.5%). Adjunctive lacosamide was efficacious in reducing seizure frequency and generally well tolerated in patients (age ≥4-<17 years) with focal seizures. NCT01921205. This trial provides Class I evidence that for children and adolescents with uncontrolled focal seizures, adjunctive lacosamide reduces seizure frequency.
DOI: 10.1212/WNL.0000000000008126
ORCID: 0000-0002-2311-2174
PubMed URL: 31462582
Type: Journal Article
Appears in Collections:Journal articles

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