A multicenter trial of oxcarbazepine oral suspension monotherapy in children newly diagnosed with partial seizures: a clinical and cognitive evaluation.
OBJECTIVE
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±8.0mg/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.
Department of Pediatrics, Korea University College of Medicine, Seoul, Republic of Korea.
So-Hee
SH
Eun
Heung Dong
HD
Kim
Hee Jung
HJ
Chung
Hoon-Chul
HC
Kang
Joon Soo
JS
Lee
Joon Sik
JS
Kim
Su Jeong
SJ
You
Han Ku
HK
Moon
Young-Mock
YM
Lee
Dong Wook
DW
Kim
Eun Sook
ES
Suh
Ji Yeon
JY
Kim
Juneyoung
J
Lee
Baik-Lin
BL
Eun
D000284:Administration, Oral; D000293:Adolescent; D002220:Carbamazepine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002648:Child; D002675:Child, Preschool; D003072:Cognition Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D004828:Epilepsies, Partial / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D000078330:Oxcarbazepine; D011446:Prospective Studies; D013535:Suspensions
D013535:Suspensions; D002220:Carbamazepine; D000078330:Oxcarbazepine