title: Adjunctive therapy with oxcarbazepine in children with partial seizures. The Oxcarbazepine Pediatric Study Group.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of oxcarbazepine (OXC) as adjunctive therapy in children with inadequately controlled partial seizures on one or two concomitant antiepileptic drugs (AEDs).
  
  
  BACKGROUND
  OXC has shown antiepileptic activity in several comparative monotherapy trials in newly diagnosed patients with epilepsy, and in a placebo-controlled monotherapy trial in hospitalized patients evaluated for epilepsy surgery.
  
  
  METHODS
  A total of 267 patients were evaluated in a multicenter, randomized, placebo-controlled trial consisting of three phases: 1) a 56-day baseline phase (patients maintained on their current AEDs); 2) a 112-day double-blind treatment phase (patients received either OXC 30-46 mg/kg/day orally or placebo); and 3) an open-label extension phase. Data are reported only from the double-blind treatment phase; the open-label extension phase is ongoing.
  
  
  METHODS
  Children (3 to 17 years old) with inadequately controlled partial seizures (simple, complex, and partial seizures evolving to secondarily generalized seizures) were enrolled.
  
  
  RESULTS
  Patients treated with OXC experienced a significantly greater median percent reduction from baseline in partial seizure frequency than patients treated with placebo (p = 0.0001; 35% versus 9%, respectively). Forty-one percent of patients treated with OXC experienced a > or =50% reduction from baseline in partial seizure frequency per 28 days compared with 22% of patients treated with placebo (p = 0.0005). Ninety-one percent of the group treated with OXC and 82% of the group treated with placebo reported > or =1 adverse event; vomiting, somnolence, dizziness, and nausea occurred more frequently (twofold or greater) in the group treated with OXC.
  
  
  CONCLUSIONS
  OXC adjunctive therapy administered in a dose range of 6 to 51 mg/kg/day (median 31.4 mg/kg/day) is safe, effective, and well tolerated in children with partial seizures.
authors.affiliation: Children's Hospital, Department of Neurology, Cincinnati, OH 45229, USA.
authors.forename: T A
authors.initials: TA
authors.lastname: Glauser
authors.forename: M
authors.initials: M
authors.lastname: Nigro
authors.forename: R
authors.initials: R
authors.lastname: Sachdeo
authors.forename: L A
authors.initials: LA
authors.lastname: Pasteris
authors.forename: S
authors.initials: S
authors.lastname: Weinstein
authors.forename: B
authors.initials: B
authors.lastname: Abou-Khalil
authors.forename: L M
authors.initials: LM
authors.lastname: Frank
authors.forename: A
authors.initials: A
authors.lastname: Grinspan
authors.forename: T
authors.initials: T
authors.lastname: Guarino
authors.forename: D
authors.initials: D
authors.lastname: Bettis
authors.forename: J
authors.initials: J
authors.lastname: Kerrigan
authors.forename: G
authors.initials: G
authors.lastname: Geoffroy
authors.forename: D
authors.initials: D
authors.lastname: Mandelbaum
authors.forename: T
authors.initials: T
authors.lastname: Jacobs
authors.forename: P
authors.initials: P
authors.lastname: Mesenbrink
authors.forename: L
authors.initials: L
authors.lastname: Kramer
authors.forename: J
authors.initials: J
authors.lastname: D'Souza
mesh_terms: D000293:Adolescent; D000927:Anticonvulsants / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002220:Carbamazepine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004569:Electroencephalography; D004828:Epilepsies, Partial / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D000078330:Oxcarbazepine; D012044:Regression Analysis; D016896:Treatment Outcome
chemical_list: C039775:10,11-dihydro-10-hydroxycarbamazepine; D000927:Anticonvulsants; D002220:Carbamazepine; D000078330:Oxcarbazepine