Evidence map›Paper›PMID 31462582›Full record

Trial reportNeurology2019

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

Viktor Farkas, Barbara Steinborn, J Robert Flamini, Ying Zhang, Nancy Yuen, Simon Borghs, Ali Bozorg, Tony Daniels, Paul Martin, Hannah C Carney and 3 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01921205 (A Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy ≥4 Years to <17 Years of Age With Partial Onset Seizures), which is not on this map. Cited by 29 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 7 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01921205 phase3completednot on this map

A Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy ≥4 Years to <17 Years of Age With Partial Onset Seizures

TypeinterventionalSponsorUCB PharmaRan2013 to 2017Enrolled404ConditionsEpilepsyArmsLacosamide, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
  2. Adjunctive treatment for pediatric focal epilepsy: a systematic review.European journal of clinical pharmacology · 2025
    Pooled it
  3. Pooled it
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  7. Psychiatric Comorbidities in Pediatric Epilepsy.Current psychiatry reports · 2020
    Pooled it
  8. Trial
  9. Trial
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  12. Article
  13. Article
  14. Article
  15. Article
  16. Impact of Age and Concurrent Antiseizure Medication Use on Lacosamide Dose to Concentration Ratio and Dosing in Pediatric Patients.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024
    Article
  17. Article
  18. Article
  19. Article
  20. The impact of anti-seizure medications on psychiatric disorders among children with epilepsy: Both a challenge and an opportunity?Journal of the Canadian Academy of Child and Adolescent Psychiatry = Journal de l'Academie canadienne de psychiatrie de l'enfant et de l'adolescent · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Viktor FarkasFrom the First Department of Pediatrics (V.F.), Semmelweis University, Budapest, Hungary; Department of Developmental Neurology (B.S.), Poznań University of Medical Sciences, Poland; PANDA Neurology (J.R.F.), Atlanta, GA; UCB Pharma (Y.Z., N.Y., A.B., T.D.), Raleigh, NC; UCB Pharma (S.B.), Slough, UK; UCB Pharma (P.M.), Braine-l'Alleud, Belgium; Evidence Scientific Solutions (H.C.C.), Horsham, UK; UCB Pharma (S.D.), Brussels, Belgium; and Austin Health (I.E.S.), Florey and Murdoch Children's Research Institute, University of Melbourne, Australia. farkas.viktor@med.semmelweis-univ.hu.
Barbara SteinbornFrom the First Department of Pediatrics (V.F.), Semmelweis University, Budapest, Hungary; Department of Developmental Neurology (B.S.), Poznań University of Medical Sciences, Poland; PANDA Neurology (J.R.F.), Atlanta, GA; UCB Pharma (Y.Z., N.Y., A.B., T.D.), Raleigh, NC; UCB Pharma (S.B.), Slough, UK; UCB Pharma (P.M.), Braine-l'Alleud, Belgium; Evidence Scientific Solutions (H.C.C.), Horsham, UK; UCB Pharma (S.D.), Brussels, Belgium; and Austin Health (I.E.S.), Florey and Murdoch Children's Research Institute, University of Melbourne, Australia.
J Robert FlaminiFrom the First Department of Pediatrics (V.F.), Semmelweis University, Budapest, Hungary; Department of Developmental Neurology (B.S.), Poznań University of Medical Sciences, Poland; PANDA Neurology (J.R.F.), Atlanta, GA; UCB Pharma (Y.Z., N.Y., A.B., T.D.), Raleigh, NC; UCB Pharma (S.B.), Slough, UK; UCB Pharma (P.M.), Braine-l'Alleud, Belgium; Evidence Scientific Solutions (H.C.C.), Horsham, UK; UCB Pharma (S.D.), Brussels, Belgium; and Austin Health (I.E.S.), Florey and Murdoch Children's Research Institute, University of Melbourne, Australia.
Ying ZhangFrom the First Department of Pediatrics (V.F.), Semmelweis University, Budapest, Hungary; Department of Developmental Neurology (B.S.), Poznań University of Medical Sciences, Poland; PANDA Neurology (J.R.F.), Atlanta, GA; UCB Pharma (Y.Z., N.Y., A.B., T.D.), Raleigh, NC; UCB Pharma (S.B.), Slough, UK; UCB Pharma (P.M.), Braine-l'Alleud, Belgium; Evidence Scientific Solutions (H.C.C.), Horsham, UK; UCB Pharma (S.D.), Brussels, Belgium; and Austin Health (I.E.S.), Florey and Murdoch Children's Research Institute, University of Melbourne, Australia.
Nancy YuenFrom the First Department of Pediatrics (V.F.), Semmelweis University, Budapest, Hungary; Department of Developmental Neurology (B.S.), Poznań University of Medical Sciences, Poland; PANDA Neurology (J.R.F.), Atlanta, GA; UCB Pharma (Y.Z., N.Y., A.B., T.D.), Raleigh, NC; UCB Pharma (S.B.), Slough, UK; UCB Pharma (P.M.), Braine-l'Alleud, Belgium; Evidence Scientific Solutions (H.C.C.), Horsham, UK; UCB Pharma (S.D.), Brussels, Belgium; and Austin Health (I.E.S.), Florey and Murdoch Children's Research Institute, University of Melbourne, Australia.
Simon BorghsFrom the First Department of Pediatrics (V.F.), Semmelweis University, Budapest, Hungary; Department of Developmental Neurology (B.S.), Poznań University of Medical Sciences, Poland; PANDA Neurology (J.R.F.), Atlanta, GA; UCB Pharma (Y.Z., N.Y., A.B., T.D.), Raleigh, NC; UCB Pharma (S.B.), Slough, UK; UCB Pharma (P.M.), Braine-l'Alleud, Belgium; Evidence Scientific Solutions (H.C.C.), Horsham, UK; UCB Pharma (S.D.), Brussels, Belgium; and Austin Health (I.E.S.), Florey and Murdoch Children's Research Institute, University of Melbourne, Australia.
Ali BozorgFrom the First Department of Pediatrics (V.F.), Semmelweis University, Budapest, Hungary; Department of Developmental Neurology (B.S.), Poznań University of Medical Sciences, Poland; PANDA Neurology (J.R.F.), Atlanta, GA; UCB Pharma (Y.Z., N.Y., A.B., T.D.), Raleigh, NC; UCB Pharma (S.B.), Slough, UK; UCB Pharma (P.M.), Braine-l'Alleud, Belgium; Evidence Scientific Solutions (H.C.C.), Horsham, UK; UCB Pharma (S.D.), Brussels, Belgium; and Austin Health (I.E.S.), Florey and Murdoch Children's Research Institute, University of Melbourne, Australia.
Tony DanielsFrom the First Department of Pediatrics (V.F.), Semmelweis University, Budapest, Hungary; Department of Developmental Neurology (B.S.), Poznań University of Medical Sciences, Poland; PANDA Neurology (J.R.F.), Atlanta, GA; UCB Pharma (Y.Z., N.Y., A.B., T.D.), Raleigh, NC; UCB Pharma (S.B.), Slough, UK; UCB Pharma (P.M.), Braine-l'Alleud, Belgium; Evidence Scientific Solutions (H.C.C.), Horsham, UK; UCB Pharma (S.D.), Brussels, Belgium; and Austin Health (I.E.S.), Florey and Murdoch Children's Research Institute, University of Melbourne, Australia.
Paul MartinFrom the First Department of Pediatrics (V.F.), Semmelweis University, Budapest, Hungary; Department of Developmental Neurology (B.S.), Poznań University of Medical Sciences, Poland; PANDA Neurology (J.R.F.), Atlanta, GA; UCB Pharma (Y.Z., N.Y., A.B., T.D.), Raleigh, NC; UCB Pharma (S.B.), Slough, UK; UCB Pharma (P.M.), Braine-l'Alleud, Belgium; Evidence Scientific Solutions (H.C.C.), Horsham, UK; UCB Pharma (S.D.), Brussels, Belgium; and Austin Health (I.E.S.), Florey and Murdoch Children's Research Institute, University of Melbourne, Australia.
Hannah C CarneyFrom the First Department of Pediatrics (V.F.), Semmelweis University, Budapest, Hungary; Department of Developmental Neurology (B.S.), Poznań University of Medical Sciences, Poland; PANDA Neurology (J.R.F.), Atlanta, GA; UCB Pharma (Y.Z., N.Y., A.B., T.D.), Raleigh, NC; UCB Pharma (S.B.), Slough, UK; UCB Pharma (P.M.), Braine-l'Alleud, Belgium; Evidence Scientific Solutions (H.C.C.), Horsham, UK; UCB Pharma (S.D.), Brussels, Belgium; and Austin Health (I.E.S.), Florey and Murdoch Children's Research Institute, University of Melbourne, Australia.
Svetlana DimovaFrom the First Department of Pediatrics (V.F.), Semmelweis University, Budapest, Hungary; Department of Developmental Neurology (B.S.), Poznań University of Medical Sciences, Poland; PANDA Neurology (J.R.F.), Atlanta, GA; UCB Pharma (Y.Z., N.Y., A.B., T.D.), Raleigh, NC; UCB Pharma (S.B.), Slough, UK; UCB Pharma (P.M.), Braine-l'Alleud, Belgium; Evidence Scientific Solutions (H.C.C.), Horsham, UK; UCB Pharma (S.D.), Brussels, Belgium; and Austin Health (I.E.S.), Florey and Murdoch Children's Research Institute, University of Melbourne, Australia.
Ingrid E SchefferFrom the First Department of Pediatrics (V.F.), Semmelweis University, Budapest, Hungary; Department of Developmental Neurology (B.S.), Poznań University of Medical Sciences, Poland; PANDA Neurology (J.R.F.), Atlanta, GA; UCB Pharma (Y.Z., N.Y., A.B., T.D.), Raleigh, NC; UCB Pharma (S.B.), Slough, UK; UCB Pharma (P.M.), Braine-l'Alleud, Belgium; Evidence Scientific Solutions (H.C.C.), Horsham, UK; UCB Pharma (S.D.), Brussels, Belgium; and Austin Health (I.E.S.), Florey and Murdoch Children's Research Institute, University of Melbourne, Australia.
SP0969 Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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% (

conclusionsAdjunctive lacosamide was efficacious in reducing seizure frequency and generally well tolerated in patients (age ≥4-<17 years) with focal seizures. CLINICALTRIALSGOV IDENTIFIER: NCT01921205. CLASSIFICATION OF EVIDENCE: This trial provides Class I evidence that for children and adolescents with uncontrolled focal seizures, adjunctive lacosamide reduces seizure frequency.

Indexed as

AdolescentAnticonvulsantsChildChild, PreschoolDouble-Blind MethodDrug Therapy, CombinationFemaleHumansLacosamideMaleProspective StudiesSeizuresTreatment OutcomeAnticonvulsantsLacosamide

Identifiers

PMID31462582
PMCPMC6808531

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Registered trials

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