Neuropsychological effects of levetiracetam and carbamazepine in children with focal epilepsy

Da Eun Jung, Rita Yu, Jung Rim Yoon, Baik Lin Eun, Soon Hak Kwon, Yun Jin Lee, So Hee Eun, Joon Soo Lee, HeungDong Kim, Sang Ook Nam, Gun Ha Kim, Su Kyeong Hwang, Soyong Eom, Dae Ryong Kang, hoonchul kang

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Abstract

Objective: To prospectively evaluate the neuropsychological effect of levetiracetam (LVT) in comparison with carbamazepine (CBZ) and its efficacy and tolerability as a monotherapy in children with focal epilepsy. Methods: A total of 121 out of 135 screened children (4-16 years) were randomly assigned to LVT or CBZ groups in a multicenter, parallel-group, open-label trial. The study's primary endpoints were defined as the end of 52 weeks of treatment, followed by analysis of changes observed in a series of follow-up neurocognitive, behavioral, and emotional function tests performed during treatment in the per protocol population. Drug efficacy and tolerability were also analyzed among the intention-to-treat (ITT) population (ClinicalTrials.gov, number NCT02208492). Results: Eighty-one patients (41 LVT, 40 CBZ) from the randomly assigned ITT population of 121 children (57 LVT, 64 CBZ) were followed up to their last visit. No significant worsening or differences were noted between groups in neuropsychological tests, except for the Children's Depression Inventory (LVT-1.97 vs CBZ +1.43, p 0.027, [+] improvement of function). LVT-treated patients showed an improvement (p 0.004) in internalizing behavioral problems on the Korean Child Behavior Checklist. Seizure-free outcomes were not different between the 2 groups (CBZ 57.8% vs LVT 66.7%, p 0.317). Conclusions: Neither LVT nor CBZ adversely affected neuropsychological function in pediatric patients. Both medications were considered equally safe and effective as monotherapy in children with focal epilepsy. Classification of evidence: This study provides Class II evidence that in patients with pediatric focal epilepsy, LVT and CBZ exhibit equivalent effects on neuropsychological function.

Original languageEnglish
Pages (from-to)2312-2319
Number of pages8
JournalNeurology
Volume84
Issue number23
DOIs
Publication statusPublished - 2015 Jun 9

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etiracetam
Partial Epilepsy
Carbamazepine
Pediatrics
Population
Neuropsychological Tests

All Science Journal Classification (ASJC) codes

  • Clinical Neurology

Cite this

Jung, Da Eun ; Yu, Rita ; Yoon, Jung Rim ; Eun, Baik Lin ; Kwon, Soon Hak ; Lee, Yun Jin ; Eun, So Hee ; Lee, Joon Soo ; Kim, HeungDong ; Nam, Sang Ook ; Kim, Gun Ha ; Hwang, Su Kyeong ; Eom, Soyong ; Kang, Dae Ryong ; kang, hoonchul. / Neuropsychological effects of levetiracetam and carbamazepine in children with focal epilepsy. In: Neurology. 2015 ; Vol. 84, No. 23. pp. 2312-2319.
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title = "Neuropsychological effects of levetiracetam and carbamazepine in children with focal epilepsy",
abstract = "Objective: To prospectively evaluate the neuropsychological effect of levetiracetam (LVT) in comparison with carbamazepine (CBZ) and its efficacy and tolerability as a monotherapy in children with focal epilepsy. Methods: A total of 121 out of 135 screened children (4-16 years) were randomly assigned to LVT or CBZ groups in a multicenter, parallel-group, open-label trial. The study's primary endpoints were defined as the end of 52 weeks of treatment, followed by analysis of changes observed in a series of follow-up neurocognitive, behavioral, and emotional function tests performed during treatment in the per protocol population. Drug efficacy and tolerability were also analyzed among the intention-to-treat (ITT) population (ClinicalTrials.gov, number NCT02208492). Results: Eighty-one patients (41 LVT, 40 CBZ) from the randomly assigned ITT population of 121 children (57 LVT, 64 CBZ) were followed up to their last visit. No significant worsening or differences were noted between groups in neuropsychological tests, except for the Children's Depression Inventory (LVT-1.97 vs CBZ +1.43, p 0.027, [+] improvement of function). LVT-treated patients showed an improvement (p 0.004) in internalizing behavioral problems on the Korean Child Behavior Checklist. Seizure-free outcomes were not different between the 2 groups (CBZ 57.8{\%} vs LVT 66.7{\%}, p 0.317). Conclusions: Neither LVT nor CBZ adversely affected neuropsychological function in pediatric patients. Both medications were considered equally safe and effective as monotherapy in children with focal epilepsy. Classification of evidence: This study provides Class II evidence that in patients with pediatric focal epilepsy, LVT and CBZ exhibit equivalent effects on neuropsychological function.",
author = "Jung, {Da Eun} and Rita Yu and Yoon, {Jung Rim} and Eun, {Baik Lin} and Kwon, {Soon Hak} and Lee, {Yun Jin} and Eun, {So Hee} and Lee, {Joon Soo} and HeungDong Kim and Nam, {Sang Ook} and Kim, {Gun Ha} and Hwang, {Su Kyeong} and Soyong Eom and Kang, {Dae Ryong} and hoonchul kang",
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Jung, DE, Yu, R, Yoon, JR, Eun, BL, Kwon, SH, Lee, YJ, Eun, SH, Lee, JS, Kim, H, Nam, SO, Kim, GH, Hwang, SK, Eom, S, Kang, DR & kang, H 2015, 'Neuropsychological effects of levetiracetam and carbamazepine in children with focal epilepsy', Neurology, vol. 84, no. 23, pp. 2312-2319. https://doi.org/10.1212/WNL.0000000000001661

Neuropsychological effects of levetiracetam and carbamazepine in children with focal epilepsy. / Jung, Da Eun; Yu, Rita; Yoon, Jung Rim; Eun, Baik Lin; Kwon, Soon Hak; Lee, Yun Jin; Eun, So Hee; Lee, Joon Soo; Kim, HeungDong; Nam, Sang Ook; Kim, Gun Ha; Hwang, Su Kyeong; Eom, Soyong; Kang, Dae Ryong; kang, hoonchul.

In: Neurology, Vol. 84, No. 23, 09.06.2015, p. 2312-2319.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Neuropsychological effects of levetiracetam and carbamazepine in children with focal epilepsy

AU - Jung, Da Eun

AU - Yu, Rita

AU - Yoon, Jung Rim

AU - Eun, Baik Lin

AU - Kwon, Soon Hak

AU - Lee, Yun Jin

AU - Eun, So Hee

AU - Lee, Joon Soo

AU - Kim, HeungDong

AU - Nam, Sang Ook

AU - Kim, Gun Ha

AU - Hwang, Su Kyeong

AU - Eom, Soyong

AU - Kang, Dae Ryong

AU - kang, hoonchul

PY - 2015/6/9

Y1 - 2015/6/9

N2 - Objective: To prospectively evaluate the neuropsychological effect of levetiracetam (LVT) in comparison with carbamazepine (CBZ) and its efficacy and tolerability as a monotherapy in children with focal epilepsy. Methods: A total of 121 out of 135 screened children (4-16 years) were randomly assigned to LVT or CBZ groups in a multicenter, parallel-group, open-label trial. The study's primary endpoints were defined as the end of 52 weeks of treatment, followed by analysis of changes observed in a series of follow-up neurocognitive, behavioral, and emotional function tests performed during treatment in the per protocol population. Drug efficacy and tolerability were also analyzed among the intention-to-treat (ITT) population (ClinicalTrials.gov, number NCT02208492). Results: Eighty-one patients (41 LVT, 40 CBZ) from the randomly assigned ITT population of 121 children (57 LVT, 64 CBZ) were followed up to their last visit. No significant worsening or differences were noted between groups in neuropsychological tests, except for the Children's Depression Inventory (LVT-1.97 vs CBZ +1.43, p 0.027, [+] improvement of function). LVT-treated patients showed an improvement (p 0.004) in internalizing behavioral problems on the Korean Child Behavior Checklist. Seizure-free outcomes were not different between the 2 groups (CBZ 57.8% vs LVT 66.7%, p 0.317). Conclusions: Neither LVT nor CBZ adversely affected neuropsychological function in pediatric patients. Both medications were considered equally safe and effective as monotherapy in children with focal epilepsy. Classification of evidence: This study provides Class II evidence that in patients with pediatric focal epilepsy, LVT and CBZ exhibit equivalent effects on neuropsychological function.

AB - Objective: To prospectively evaluate the neuropsychological effect of levetiracetam (LVT) in comparison with carbamazepine (CBZ) and its efficacy and tolerability as a monotherapy in children with focal epilepsy. Methods: A total of 121 out of 135 screened children (4-16 years) were randomly assigned to LVT or CBZ groups in a multicenter, parallel-group, open-label trial. The study's primary endpoints were defined as the end of 52 weeks of treatment, followed by analysis of changes observed in a series of follow-up neurocognitive, behavioral, and emotional function tests performed during treatment in the per protocol population. Drug efficacy and tolerability were also analyzed among the intention-to-treat (ITT) population (ClinicalTrials.gov, number NCT02208492). Results: Eighty-one patients (41 LVT, 40 CBZ) from the randomly assigned ITT population of 121 children (57 LVT, 64 CBZ) were followed up to their last visit. No significant worsening or differences were noted between groups in neuropsychological tests, except for the Children's Depression Inventory (LVT-1.97 vs CBZ +1.43, p 0.027, [+] improvement of function). LVT-treated patients showed an improvement (p 0.004) in internalizing behavioral problems on the Korean Child Behavior Checklist. Seizure-free outcomes were not different between the 2 groups (CBZ 57.8% vs LVT 66.7%, p 0.317). Conclusions: Neither LVT nor CBZ adversely affected neuropsychological function in pediatric patients. Both medications were considered equally safe and effective as monotherapy in children with focal epilepsy. Classification of evidence: This study provides Class II evidence that in patients with pediatric focal epilepsy, LVT and CBZ exhibit equivalent effects on neuropsychological function.

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