Long-term therapeutic effect of eslicarbazepine acetate in children: An open-label extension of a cognition study in children aged 6-16 years
Long-term therapeutic effect of eslicarbazepine acetate in children: An open-label extension of a cognition study in children aged 6-16 years
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 One child was withdrawn because of splenomegaly that was considered possibly related to ESL.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.
Adolescents, Children, Eslicarbazepine acetate, Focal seizures
Veggiotti, Pierangelo
971d8792-c9dd-408d-a10c-4438124db31a
Jozwiak, Sergiusz
32101edd-04f0-4879-a8eb-cd1da9162af4
Kirkham, Fenella
1dfbc0d5-aebe-4439-9fb2-dac6503bcd58
Moreira, Joana
55a8ba5d-0294-4443-a5a0-97a96707e6fa
Pereira, Ana
7a89f899-34a3-45ef-b5b2-ae9170371de1
Ikedo, Fabio
59a703d5-f8a5-4ede-8282-95d5ea2ebfc4
Gama, Helena
b9e92b6b-1038-4091-9100-f87c03e25db6
February 2022
Veggiotti, Pierangelo
971d8792-c9dd-408d-a10c-4438124db31a
Jozwiak, Sergiusz
32101edd-04f0-4879-a8eb-cd1da9162af4
Kirkham, Fenella
1dfbc0d5-aebe-4439-9fb2-dac6503bcd58
Moreira, Joana
55a8ba5d-0294-4443-a5a0-97a96707e6fa
Pereira, Ana
7a89f899-34a3-45ef-b5b2-ae9170371de1
Ikedo, Fabio
59a703d5-f8a5-4ede-8282-95d5ea2ebfc4
Gama, Helena
b9e92b6b-1038-4091-9100-f87c03e25db6
Veggiotti, Pierangelo, Jozwiak, Sergiusz, Kirkham, Fenella, Moreira, Joana, Pereira, Ana, Ikedo, Fabio and Gama, Helena
(2022)
Long-term therapeutic effect of eslicarbazepine acetate in children: An open-label extension of a cognition study in children aged 6-16 years.
Epilepsy & Behavior, 127, [108515].
(doi:10.1016/j.yebeh.2021.108515).
Abstract
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.
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More information
Accepted/In Press date: 15 December 2021
e-pub ahead of print date: 3 January 2022
Published date: February 2022
Additional Information:
Funding Information:
We would like to thank Nicola Ryan who wrote the first draft of this manuscript on behalf of Springer Healthcare Communications. This medical writing assistance was funded by Bial.
Funding Information:
This study was sponsored by Bial – Portela & Ca. S.A. Bial participated in the study design analysis and interpretation of data, and review and approval of the manuscript to submit for publication. Funding for manuscript development was provided by Bial – Portela & Ca. S.A.
Publisher Copyright:
© 2021 The Author(s)
Keywords:
Adolescents, Children, Eslicarbazepine acetate, Focal seizures
Identifiers
Local EPrints ID: 470225
URI: http://eprints.soton.ac.uk/id/eprint/470225
ISSN: 1525-5050
PURE UUID: fea7f0b2-3ebf-4920-9cc6-6dbb360ff318
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Date deposited: 04 Oct 2022 16:51
Last modified: 17 Mar 2024 02:53
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Contributors
Author:
Pierangelo Veggiotti
Author:
Sergiusz Jozwiak
Author:
Joana Moreira
Author:
Ana Pereira
Author:
Fabio Ikedo
Author:
Helena Gama
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