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

Adolescent Anticonvulsants / administration & dosage Child Child, Preschool Double-Blind Method Drug Therapy, Combination Female Humans Lacosamide / administration & dosage Male Prospective Studies Seizures / blood Treatment Outcome

Journal

Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060

Informations de publication

Date de publication:
17 09 2019
Historique:
received: 10 10 2018
accepted: 26 04 2019
pubmed: 30 8 2019
medline: 31 1 2020
entrez: 30 8 2019
Statut: ppublish

Résumé

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% ( 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.

Identifiants

DOI: 10.1212/WNL.0000000000008126 PMID: 31462582 PMC: PMC6808531
pubmed: 31462582
pii: WNL.0000000000008126
doi: 10.1212/WNL.0000000000008126
pmc: PMC6808531
doi:

Substances chimiques

Anticonvulsants 0
Lacosamide 563KS2PQY5

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e1212-e1226

Informations de copyright

Copyright © 2019 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

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Auteurs

Viktor Farkas (V)

From 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 Steinborn (B)

From 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 Flamini (JR)

From 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 Zhang (Y)

From 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 Yuen (N)

From 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 Borghs (S)

From 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 Bozorg (A)

From 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 Daniels (T)

From 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 Martin (P)

From 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 Carney (HC)

From 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 Dimova (S)

From 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 Scheffer (IE)

From 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.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adolescent › Efficacy and tolerability of adjunctive...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Agents du système nerveux central › Anticonvulsivants › Efficacy and tolerability of adjunctive...
questionsmedicales.fr › Personnes › Tranches d'âge › Enfant › Efficacy and tolerability of adjunctive...
questionsmedicales.fr › Personnes › Tranches d'âge › Enfant › Enfant d'âge préscolaire › Efficacy and tolerability of adjunctive...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en double aveugle › Efficacy and tolerability of adjunctive...
questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Association de médicaments › Efficacy and tolerability of adjunctive...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Efficacy and tolerability of adjunctive...
questionsmedicales.fr › Composés chimiques organiques › Acides carboxyliques › Acides acycliques › Acétamides › Lacosamide › Efficacy and tolerability of adjunctive...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études prospectives › Efficacy and tolerability of adjunctive...
questionsmedicales.fr › États, signes et symptômes pathologiques › Signes et symptômes › Manifestations neurologiques › Crises épileptiques › Efficacy and tolerability of adjunctive...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Efficacy and tolerability of adjunctive...