PMID- 34991056
OWN - NLM
STAT- MEDLINE
DCOM- 20220318
LR  - 20220318
IS  - 1525-5069 (Electronic)
IS  - 1525-5050 (Linking)
VI  - 127
DP  - 2022 Feb
TI  - Long-term therapeutic effect of eslicarbazepine acetate in children: An 
      open-label extension of a cognition study in children aged 6-16 years.
PG  - 108515
LID - S1525-5050(21)00776-9 [pii]
LID - 10.1016/j.yebeh.2021.108515 [doi]
AB  - OBJECTIVE: In Europe, eslicarbazepine acetate (ESL) is approved as adjunctive 
      therapy for the treatment of focal seizures (FS) in children aged >6 years. In 
      the US, ESL is approved as both monotherapy and adjunctive therapy for the 
      treatment of FS in patients aged >/=4 years. In a phase II study of children aged 
      6-16 years with FS, ESL had no significant effects on attention or behavioral 
      functioning and decreased seizure frequency during double-blind therapy and a 
      1-year open-label extension (OLE). This report presents data from an additional 
      2-year OLE of the phase II study. METHODS: Previous recipients of ESL or placebo 
      were treated with open-label ESL (10-30 mg/kg/day, adjusted for clinical response 
      and/or adverse events [AEs]). Safety was assessed by incidence of 
      treatment-emergent AEs (TEAEs). Efficacy endpoints were treatment retention time 
      and change from baseline in Clinical Global Impression-Severity (CGI-S) scale 
      scores. RESULTS: Forty-two patients entered and 31 (73.8%) completed the 2-year 
      OLE. Median treatment retention time was 735 (95% confidence interval 728-741) 
      days. Seven patients (17% of total, 23% of completed) experienced >/=1 TEAE during 
      the 2-year OLE, mostly of mild or moderate intensity. The incidence of serious 
      TEAEs was low (n = 2; 5% of total, 6% of completed) and none were related to ESL. 
      One child was withdrawn because of splenomegaly that was considered possibly 
      related to ESL. The only change from baseline in CGI-S was a 0.5-point reduction 
      in the severity of illness score. All findings were consistent across patient 
      subgroups based on previous double-blind treatment (placebo or ESL) and patient 
      age (6-11 or 12-16 years). CONCLUSIONS: The majority of patients remained on ESL 
      during the 2-year OLE, and treatment efficacy was maintained. Adverse events were 
      consistent with the known safety profile of ESL, and no new safety signals were 
      identified.
CI  - Copyright (c) 2021 The Author(s). Published by Elsevier Inc. All rights reserved.
FAU - Veggiotti, Pierangelo
AU  - Veggiotti P
AD  - Pediatric Neurology Unit, Vittore Buzzi Hospital Milan, Via Castelvetro, 32 - 
      Ospedale dei Bambini Vittore Buzzi - Pad. A 20154, Milan, Italy; Child 
      Neuropsychiatry Chair, University of Milan, Milan, Italy.
FAU - Jozwiak, Sergiusz
AU  - Jozwiak S
AD  - Department of Child Neurology, Medical University of Warsaw, Al. Zwirki i Wigury 
      63a, 02-091 Warsaw, Poland.
FAU - Kirkham, Fenella
AU  - Kirkham F
AD  - University Hospital, Southampton, UK; University of Southampton, University Road, 
      Southampton SO17 1BJ, UK; UCL Great Ormond Street Institute of Child Health, 
      Gower Street, London WC1E 6BT, UK; King's College Hospital, Denmark Hill, London 
      SE5 9RS, UK.
FAU - Moreira, Joana
AU  - Moreira J
AD  - BIAL-Portela & C feminine, S.A., A Avenida da Siderurgia Nacional, 4745‑457 S. Mamede do 
      Coronado, Portugal.
FAU - Pereira, Ana
AU  - Pereira A
AD  - BIAL-Portela & C feminine, S.A., A Avenida da Siderurgia Nacional, 4745‑457 S. Mamede do 
      Coronado, Portugal.
FAU - Ikedo, Fabio
AU  - Ikedo F
AD  - BIAL-Portela & C feminine, S.A., A Avenida da Siderurgia Nacional, 4745‑457 S. Mamede do 
      Coronado, Portugal.
FAU - Gama, Helena
AU  - Gama H
AD  - BIAL-Portela & C feminine, S.A., A Avenida da Siderurgia Nacional, 4745‑457 S. Mamede do 
      Coronado, Portugal. Electronic address: Helena.Gama@bial.com.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220103
PL  - United States
TA  - Epilepsy Behav
JT  - Epilepsy & behavior : E&B
JID - 100892858
RN  - 0 (Anticonvulsants)
RN  - 0 (Dibenzazepines)
RN  - BEA68ZVB2K (eslicarbazepine acetate)
SB  - IM
MH  - Adolescent
MH  - *Anticonvulsants/adverse effects
MH  - Child
MH  - Child, Preschool
MH  - Cognition
MH  - *Dibenzazepines/adverse effects
MH  - Double-Blind Method
MH  - Humans
MH  - Seizures/drug therapy
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Adolescents
OT  - Children
OT  - Eslicarbazepine acetate
OT  - Focal seizures
COIS- Declaration of Competing Interest Pierangelo Veggiotti has received speaker's fee 
      from Eisai, Nutricia and Schar SPA. Sergiusz Jozwiak reports receiving consulting 
      fees from BIAL - Portela & Ca, S.A. Fenella Kirkham has received fees for her 
      work in advisory boards for BIAL/Eisai with expenses paid to present data at 
      meetings in Europe (Helsinki, London, Lyon and Athens).
EDAT- 2022/01/07 06:00
MHDA- 2022/03/19 06:00
CRDT- 2022/01/06 20:28
PHST- 2021/07/21 00:00 [received]
PHST- 2021/12/15 00:00 [revised]
PHST- 2021/12/15 00:00 [accepted]
PHST- 2022/01/07 06:00 [pubmed]
PHST- 2022/03/19 06:00 [medline]
PHST- 2022/01/06 20:28 [entrez]
AID - S1525-5050(21)00776-9 [pii]
AID - 10.1016/j.yebeh.2021.108515 [doi]
PST - ppublish
SO  - Epilepsy Behav. 2022 Feb;127:108515. doi: 10.1016/j.yebeh.2021.108515. Epub 2022 
      Jan 3.