Oxcarbazepine adjunctive therapy in infants and young children with partial seizures.
OBJECTIVE
To evaluate the efficacy, safety, and pharmacokinetics of oxcarbazepine as adjunctive therapy in infants and young children (1 month to < 4 years).


METHODS
Children 1 month to < 4 years of age with inadequately controlled partial seizures taking up to two concomitant antiepileptic drugs (AEDs) were enrolled in this rater-blind, randomized, parallel-group study. Patients received either high-dose (60 mg/kg/day) or low-dose (10 mg/kg/day) oxcarbazepine as oral suspension. The primary efficacy variable was the absolute change in electrographic partial seizures with a behavioral correlate (type 1 seizure) frequency per 24 hours during the last 72 hours of continuous video-EEG monitoring in the treatment phase compared with baseline seizure frequency.


RESULTS
Of 191 patients screened, 128 were randomized: 64 to both oxcarbazepine dose groups. The median absolute change in type 1 seizure frequency per 24 hours was more effective for the high-dose group (-2.00) compared with the low-dose group (-1.37; p = 0.043). The median percentage reduction in type 1 seizure frequency per 24 hours was also greater in the high-dose group (83.33%) than in the low-dose group (46.18%; p = 0.047). The most frequent adverse events (> or = 10%) were somnolence and pyrexia, and most were mild in severity.


CONCLUSIONS
In this study, high-dose oxcarbazepine was significantly more effective than low-dose oxcarbazepine in controlling partial seizures in infants and very young children.
Piña-Garza
J E
JE
Vanderbilt Children's Hospital, Pediatric Neurology, Nashville, TN 37232, USA. eric.pina-garza@vanderbilt.edu
Espinoza
R
R
Nordli
D
D
Bennett
D A
DA
Spirito
S
S
Stites
T E
TE
Tang
D
D
Sturm
Y
Y
D000284:Administration, Oral; D000367:Age Factors; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000009:adverse effects* / Q000493:pharmacokinetics; D002220:Carbamazepine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D002675:Child, Preschool; D006970:Disorders of Excessive Somnolence / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy* / Q000517:prevention & control*; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D000078330:Oxcarbazepine; D016037:Single-Blind Method; D013997:Time Factors
D000927:Anticonvulsants; D002220:Carbamazepine; D000078330:Oxcarbazepine