Efficacy and safety of lacosamide as an adjunctive therapy for refractory focal epilepsy in paediatric patients: a retrospective single‐centre study

Toupin, Jean-François; Lortie, Anne; Major, Philippe; Diadori, Paola; Vanasse, Michel; Rossignol, Elsa; D’Anjou, Guy; Perreault, Sébastien; Larbrisseau, Albert; Carmant, Lionel; Birca, Ala

doi:10.1684/epd.2015.0782

Cited by 24 publications

(13 citation statements)

References 21 publications

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“…Although achieving seizure control produces a secondary positive impact on cognitive and behavioral functioning in children and adolescents, some authors consider lacosamide has a specific primary cognitive enhancing effect improving information processing speed [45]. By contrast, several articles have reported cases of mild negative mood and behavioral changes (5-25%) [18,10,15,13,26,46,12]. In few special cases, lacosamide was discontinued because of severe hyperactivity, aggression, and inattention [8,21].…”

Section: Discussionmentioning

confidence: 99%

Efficacy of lacosamide in children and adolescents with drug-resistant epilepsy and refractory status epilepticus: A systematic review

Rosa

Ladino

Rodríguez

et al. 2018

Seizure

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Current evidence shows lacosamide as a good option in pediatric patients with focal drug-resistant epilepsy and refractory status epilepticus as an add-on therapy given its efficacy on seizure control and safety profile. The use of lacosamide in Lennox-Gastaut syndrome shows conflicting data. Large randomized controlled studies in the pediatric population are necessary to substantiate these findings.

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Section: Discussionmentioning

confidence: 99%

Efficacy of lacosamide in children and adolescents with drug-resistant epilepsy and refractory status epilepticus: A systematic review

Rosa

Ladino

Rodríguez

et al. 2018

Seizure

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“…An open‐label study to determine safety, tolerability, and efficacy of oral LCM in children with epilepsy (clinicaltrials.gov identifier NCT00938912) is being conducted in children 1 month to 17 years of age, but the study has not yet been completed. A number of observational studies on the off‐label use of LCM as a maintenance AED in children has been reported (see Table ), but have the limitations of short follow‐up times, variable or unspecified time points for efficacy assessment, small sample sizes, and the retrospective use of the 50% responder rate outcome measure.…”

Section: Discussionmentioning

confidence: 99%

Lacosamide use in children with epilepsy: Retention rate and effect of concomitant sodium channel blockers in a large cohort

McGinnis

Kessler

2016

Epilepsia

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SUMMARYObjectives: To evaluate the effectiveness of lacosamide (LCM) in pediatric patients, using time to treatment failure as the outcome measure, and to assess the impact of concomitant sodium channel blocker (SCB) use on LCM retention. Methods: This is a retrospective cohort study of patients <21 years old receiving LCM from 2010 to 2015. Kaplan-Meier survival curves were generated for time to LCM failure, defined as discontinuation of LCM or addition of another antiepileptic therapy. The impact of concomitant use of traditional SCB agents (phenytoin, carbamazepine, oxcarbazepine, and/or lamotrigine) and other factors including age, seizure types, fast drug titration, and prior antiepileptic drug history were evaluated using Cox regression. Results: The analysis cohort included 223 patients, of whom 116 were taking one or more SCBs, with median follow-up of 7.4 months (1-53 months). For all patients, the probability of remaining on LCM without addition of another therapy was 44.7% at 12 months and 25.6% at 24 months. Concomitant SCB use was an independent predictor of time to LCM failure (hazard ratio [HR] 1.91, 95% confidence interval [CI] 1.38-2.65, p < 0.001).Although treatment emergent adverse effects were reported more often in patients taking SCB (65% vs. 39%, p < 0.001), intolerability was rarely the sole reason cited for LCM discontinuation, and SCB use was strongly associated with LCM failure, even when controlling for presence of treatment emergent adverse effects (adjusted HR 1.99, 95% CI 1.36-2.90, p < 0.001). Significance: This study provides observational evidence for treatment persistence of LCM in children, in a large cohort with long-term follow-up, using time to treatment failure as the outcome measure. Concomitant SCB use was a key factor increasing risk of LCM failure, but not due to treatment-emergent adverse effects alone.

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“…10–12 The use of adjunctive lacosamide in children and adolescents has been investigated in open-label trials 13,14 and reported in observational studies. 15–20 The objective of this randomized, double-blind, placebo-controlled trial was to evaluate the efficacy and tolerability of adjunctive lacosamide in children and adolescents (≥4–<17 years of age) with uncontrolled focal seizures.…”

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confidence: 99%

Efficacy and tolerability of adjunctive lacosamide in pediatric patients with focal seizures

Farkas¹,

Steinborn²,

Flamini³

et al. 2019

Neurology

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ObjectiveTo evaluate efficacy and tolerability of adjunctive lacosamide in children and adolescents with uncontrolled focal (partial-onset) seizures.MethodsIn 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.ResultsThree 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%).ConclusionsAdjunctive lacosamide was efficacious in reducing seizure frequency and generally well tolerated in patients (age ≥4–<17 years) with focal seizures.ClinicalTrials.gov identifier:NCT01921205.Classification of evidenceThis trial provides Class I evidence that for children and adolescents with uncontrolled focal seizures, adjunctive lacosamide reduces seizure frequency.

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Efficacy and safety of lacosamide as an adjunctive therapy for refractory focal epilepsy in paediatric patients: a retrospective single‐centre study

Cited by 24 publications

References 21 publications

Efficacy of lacosamide in children and adolescents with drug-resistant epilepsy and refractory status epilepticus: A systematic review

Efficacy of lacosamide in children and adolescents with drug-resistant epilepsy and refractory status epilepticus: A systematic review

Lacosamide use in children with epilepsy: Retention rate and effect of concomitant sodium channel blockers in a large cohort

Efficacy and tolerability of adjunctive lacosamide in pediatric patients with focal seizures

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