title: Oxcarbazepine adjunctive therapy in infants and young children with partial seizures.
abstract: 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.
authors.affiliation: Vanderbilt Children's Hospital, Pediatric Neurology, Nashville, TN 37232, USA. eric.pina-garza@vanderbilt.edu
authors.forename: J E
authors.initials: JE
authors.lastname: Piña-Garza
authors.forename: R
authors.initials: R
authors.lastname: Espinoza
authors.forename: D
authors.initials: D
authors.lastname: Nordli
authors.forename: D A
authors.initials: DA
authors.lastname: Bennett
authors.forename: S
authors.initials: S
authors.lastname: Spirito
authors.forename: T E
authors.initials: TE
authors.lastname: Stites
authors.forename: D
authors.initials: D
authors.lastname: Tang
authors.forename: Y
authors.initials: Y
authors.lastname: Sturm
mesh_terms: 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
chemical_list: D000927:Anticonvulsants; D002220:Carbamazepine; D000078330:Oxcarbazepine