A multicenter trial of oxcarbazepine oral suspension monotherapy in children newly diagnosed with partial seizures: A clinical and cognitive evaluation

So-Hee Eun, Heung Dong Kim, Hee Jung Chung, Hoon Chul Kang, Joon Soo Lee, Joon Sik Kim, Su Jeong You, Han Ku Moon, Young Mock Lee, Dong Wook Kim, Eun Sook Suh, Ji Yeon Kim, Juneyoung Lee, Baik-Lin Eun

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Purpose: We conducted a prospective, multicenter, open label trial to evaluate the effectiveness of oxcarbazepine (OXC) oral suspension as monotherapy for children newly diagnosed with partial seizures. Methods: This trial included a two- to eight-week titration and stabilization period to achieve effective target doses and a 24-week maintenance phase. The primary outcome measure was the seizure-free rate over six months, while a secondary measure was the change in cognition and behavior from screening to the end of the maintenance phase. The effectiveness of OXC was compared in intellectually normal versus intellectually impaired children (intelligence quotient <70). Results: We enrolled 171 patients and analyzed 168 as the per-protocol (PP) group (3 patients had protocol violations). The mean age of the PP group was 8.4 ± 2.7 years. The maintenance dose of OXC was 24.9 ± 8.0 mg/kg/day. Of the 168 patients included in the efficacy analysis, 122 (72.6%) completed the study and 94 (56.0%) became seizure-free after the OXC treatment. Comparing the efficacy of OXC for intellectually normal and intellectually impaired patients, 79 (56.8%) of the 139 intellectually normal patients and 15 (51.7%) of the 29 intellectually impaired patients became seizure-free (P = 0.61). After treatment, intelligence scale scores improved in intellectually normal patients compared to the intellectually impaired children (P < 0.05). Social problems quantified by behavior scales improved in intellectually impaired patients compared to intellectually normal children (P < 0.05). Conclusions: OXC is effective and well-tolerated as monotherapy in children with partial seizures. There was no difference in the effectiveness of OXC between intellectually normal and intellectually impaired children.

Original languageEnglish
Pages (from-to)679-684
Number of pages6
JournalSeizure
Volume21
Issue number9
DOIs
Publication statusPublished - 2012 Nov 1

Fingerprint

Multicenter Studies
Suspensions
Seizures
Intelligence
Maintenance
oxcarbazepine
Social Problems
Cognition
Outcome Assessment (Health Care)
Therapeutics

Keywords

  • Behavior
  • Child
  • Cognition
  • Epilepsy
  • Oxcarbazepine

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

A multicenter trial of oxcarbazepine oral suspension monotherapy in children newly diagnosed with partial seizures : A clinical and cognitive evaluation. / Eun, So-Hee; Kim, Heung Dong; Chung, Hee Jung; Kang, Hoon Chul; Lee, Joon Soo; Kim, Joon Sik; You, Su Jeong; Moon, Han Ku; Lee, Young Mock; Kim, Dong Wook; Suh, Eun Sook; Kim, Ji Yeon; Lee, Juneyoung; Eun, Baik-Lin.

In: Seizure, Vol. 21, No. 9, 01.11.2012, p. 679-684.

Research output: Contribution to journalArticle

Eun, So-Hee ; Kim, Heung Dong ; Chung, Hee Jung ; Kang, Hoon Chul ; Lee, Joon Soo ; Kim, Joon Sik ; You, Su Jeong ; Moon, Han Ku ; Lee, Young Mock ; Kim, Dong Wook ; Suh, Eun Sook ; Kim, Ji Yeon ; Lee, Juneyoung ; Eun, Baik-Lin. / A multicenter trial of oxcarbazepine oral suspension monotherapy in children newly diagnosed with partial seizures : A clinical and cognitive evaluation. In: Seizure. 2012 ; Vol. 21, No. 9. pp. 679-684.
@article{b0c169ebd16a4af791eda3a175e96a66,
title = "A multicenter trial of oxcarbazepine oral suspension monotherapy in children newly diagnosed with partial seizures: A clinical and cognitive evaluation",
abstract = "Purpose: We conducted a prospective, multicenter, open label trial to evaluate the effectiveness of oxcarbazepine (OXC) oral suspension as monotherapy for children newly diagnosed with partial seizures. Methods: This trial included a two- to eight-week titration and stabilization period to achieve effective target doses and a 24-week maintenance phase. The primary outcome measure was the seizure-free rate over six months, while a secondary measure was the change in cognition and behavior from screening to the end of the maintenance phase. The effectiveness of OXC was compared in intellectually normal versus intellectually impaired children (intelligence quotient <70). Results: We enrolled 171 patients and analyzed 168 as the per-protocol (PP) group (3 patients had protocol violations). The mean age of the PP group was 8.4 ± 2.7 years. The maintenance dose of OXC was 24.9 ± 8.0 mg/kg/day. Of the 168 patients included in the efficacy analysis, 122 (72.6{\%}) completed the study and 94 (56.0{\%}) became seizure-free after the OXC treatment. Comparing the efficacy of OXC for intellectually normal and intellectually impaired patients, 79 (56.8{\%}) of the 139 intellectually normal patients and 15 (51.7{\%}) of the 29 intellectually impaired patients became seizure-free (P = 0.61). After treatment, intelligence scale scores improved in intellectually normal patients compared to the intellectually impaired children (P < 0.05). Social problems quantified by behavior scales improved in intellectually impaired patients compared to intellectually normal children (P < 0.05). Conclusions: OXC is effective and well-tolerated as monotherapy in children with partial seizures. There was no difference in the effectiveness of OXC between intellectually normal and intellectually impaired children.",
keywords = "Behavior, Child, Cognition, Epilepsy, Oxcarbazepine",
author = "So-Hee Eun and Kim, {Heung Dong} and Chung, {Hee Jung} and Kang, {Hoon Chul} and Lee, {Joon Soo} and Kim, {Joon Sik} and You, {Su Jeong} and Moon, {Han Ku} and Lee, {Young Mock} and Kim, {Dong Wook} and Suh, {Eun Sook} and Kim, {Ji Yeon} and Juneyoung Lee and Baik-Lin Eun",
year = "2012",
month = "11",
day = "1",
doi = "10.1016/j.seizure.2012.07.007",
language = "English",
volume = "21",
pages = "679--684",
journal = "Seizure : the journal of the British Epilepsy Association",
issn = "1059-1311",
publisher = "W.B. Saunders Ltd",
number = "9",

}

TY - JOUR

T1 - A multicenter trial of oxcarbazepine oral suspension monotherapy in children newly diagnosed with partial seizures

T2 - A clinical and cognitive evaluation

AU - Eun, So-Hee

AU - Kim, Heung Dong

AU - Chung, Hee Jung

AU - Kang, Hoon Chul

AU - Lee, Joon Soo

AU - Kim, Joon Sik

AU - You, Su Jeong

AU - Moon, Han Ku

AU - Lee, Young Mock

AU - Kim, Dong Wook

AU - Suh, Eun Sook

AU - Kim, Ji Yeon

AU - Lee, Juneyoung

AU - Eun, Baik-Lin

PY - 2012/11/1

Y1 - 2012/11/1

N2 - Purpose: We conducted a prospective, multicenter, open label trial to evaluate the effectiveness of oxcarbazepine (OXC) oral suspension as monotherapy for children newly diagnosed with partial seizures. Methods: This trial included a two- to eight-week titration and stabilization period to achieve effective target doses and a 24-week maintenance phase. The primary outcome measure was the seizure-free rate over six months, while a secondary measure was the change in cognition and behavior from screening to the end of the maintenance phase. The effectiveness of OXC was compared in intellectually normal versus intellectually impaired children (intelligence quotient <70). Results: We enrolled 171 patients and analyzed 168 as the per-protocol (PP) group (3 patients had protocol violations). The mean age of the PP group was 8.4 ± 2.7 years. The maintenance dose of OXC was 24.9 ± 8.0 mg/kg/day. Of the 168 patients included in the efficacy analysis, 122 (72.6%) completed the study and 94 (56.0%) became seizure-free after the OXC treatment. Comparing the efficacy of OXC for intellectually normal and intellectually impaired patients, 79 (56.8%) of the 139 intellectually normal patients and 15 (51.7%) of the 29 intellectually impaired patients became seizure-free (P = 0.61). After treatment, intelligence scale scores improved in intellectually normal patients compared to the intellectually impaired children (P < 0.05). Social problems quantified by behavior scales improved in intellectually impaired patients compared to intellectually normal children (P < 0.05). Conclusions: OXC is effective and well-tolerated as monotherapy in children with partial seizures. There was no difference in the effectiveness of OXC between intellectually normal and intellectually impaired children.

AB - Purpose: We conducted a prospective, multicenter, open label trial to evaluate the effectiveness of oxcarbazepine (OXC) oral suspension as monotherapy for children newly diagnosed with partial seizures. Methods: This trial included a two- to eight-week titration and stabilization period to achieve effective target doses and a 24-week maintenance phase. The primary outcome measure was the seizure-free rate over six months, while a secondary measure was the change in cognition and behavior from screening to the end of the maintenance phase. The effectiveness of OXC was compared in intellectually normal versus intellectually impaired children (intelligence quotient <70). Results: We enrolled 171 patients and analyzed 168 as the per-protocol (PP) group (3 patients had protocol violations). The mean age of the PP group was 8.4 ± 2.7 years. The maintenance dose of OXC was 24.9 ± 8.0 mg/kg/day. Of the 168 patients included in the efficacy analysis, 122 (72.6%) completed the study and 94 (56.0%) became seizure-free after the OXC treatment. Comparing the efficacy of OXC for intellectually normal and intellectually impaired patients, 79 (56.8%) of the 139 intellectually normal patients and 15 (51.7%) of the 29 intellectually impaired patients became seizure-free (P = 0.61). After treatment, intelligence scale scores improved in intellectually normal patients compared to the intellectually impaired children (P < 0.05). Social problems quantified by behavior scales improved in intellectually impaired patients compared to intellectually normal children (P < 0.05). Conclusions: OXC is effective and well-tolerated as monotherapy in children with partial seizures. There was no difference in the effectiveness of OXC between intellectually normal and intellectually impaired children.

KW - Behavior

KW - Child

KW - Cognition

KW - Epilepsy

KW - Oxcarbazepine

UR - http://www.scopus.com/inward/record.url?scp=84866380225&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84866380225&partnerID=8YFLogxK

U2 - 10.1016/j.seizure.2012.07.007

DO - 10.1016/j.seizure.2012.07.007

M3 - Article

C2 - 22902287

AN - SCOPUS:84866380225

VL - 21

SP - 679

EP - 684

JO - Seizure : the journal of the British Epilepsy Association

JF - Seizure : the journal of the British Epilepsy Association

SN - 1059-1311

IS - 9

ER -