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.
  
  
  METHODS
  This study provides Class II evidence that in patients with pediatric focal epilepsy, LVT and CBZ exhibit equivalent effects on neuropsychological function.
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
authors.forename: Da Eun
authors.initials: DE
authors.lastname: Jung
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
authors.forename: Rita
authors.initials: R
authors.lastname: Yu
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
authors.forename: Jung-Rim
authors.initials: JR
authors.lastname: Yoon
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
authors.forename: Baik-Lin
authors.initials: BL
authors.lastname: Eun
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
authors.forename: Soon Hak
authors.initials: SH
authors.lastname: Kwon
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
authors.forename: Yun Jin
authors.initials: YJ
authors.lastname: Lee
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
authors.forename: So-Hee
authors.initials: SH
authors.lastname: Eun
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
authors.forename: Joon Soo
authors.initials: JS
authors.lastname: Lee
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
authors.forename: Heung Dong
authors.initials: HD
authors.lastname: Kim
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
authors.forename: Sang Ook
authors.initials: SO
authors.lastname: Nam
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
authors.forename: Gun-Ha
authors.initials: GH
authors.lastname: Kim
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
authors.forename: Su-Kyeong
authors.initials: SK
authors.lastname: Hwang
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
authors.forename: Soyong
authors.initials: S
authors.lastname: Eom
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
authors.forename: Dae Ryong
authors.initials: DR
authors.lastname: Kang
authors.affiliation: From the Departments of Pediatrics (D.E.J.) and Biostatistics (D.R.K.), Ajou University School of Medicine, Suwon; the Division of Pediatric Neurology (R.Y., J.-R.Y., J.S.L., H.D.K., S.E., H.-C.K.), Department of Pediatrics, Severance Children's Hospital, Epilepsy Research Institute, Yonsei University College of Medicine, Seoul; the Department of Pediatrics (B.-L.E., S.-H.E., G.-H.K.), Kuro Hospital, Korea University College of Medicine, Seoul; the Department of Pediatrics (S.H.K., S.-K.H.), Kyungpook National University School of Medicine, Daegu; the Department of Pediatrics (Y.J.L., S.O.N.), Pusan National University Children's Hospital, Pusan National University School of Medicine, Yangsan; and the Department of Pediatrics (S.-H.E.), Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea. hipo0207@yuhs.ac.
authors.forename: Hoon-Chul
authors.initials: HC
authors.lastname: Kang
mesh_terms: D000293:Adolescent; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D002220:Carbamazepine / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D002648:Child; D002652:Child Behavior / Q000187:drug effects*; D002675:Child, Preschool; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007360:Intelligence / Q000187:drug effects*; D000077287:Levetiracetam; D008297:Male; D010889:Piracetam / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D066107:Social Skills; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D002220:Carbamazepine; D000077287:Levetiracetam; D010889:Piracetam