SAFETY AND TOLERABILITY OF OXCARBAZEPINE IN INFANTS AND YOUNG CHILDREN WITH INADEQUATELY-CONTROLLED PARTIAL SEIZURES
Abstract number :
1.289
Submission category :
Year :
2003
Submission ID :
639
Source :
www.aesnet.org
Presentation date :
12/6/2003 12:00:00 AM
Published date :
Dec 1, 2003, 06:00 AM
Authors :
Ralph S. Northam, Michael Duchowny, Surinder Mangat, Hai Jiang, Yvonne E. Sturm Division of Pediatric Neurology, Monarch Research Associates, Child & Adolescent Neurology, Norfolk, VA; Dept of Neurology, Miami Children[rsquo]s Hospital, Miami, FL; Neurolo
The efficacy and safety of oxcarbazepine as adjunctive therapy for partial seizures has been established in children [ge]3 years of age (Glauser TA et al, Neurology 2000;54:2237 44). The safety and tolerability of oxcarbazepine as adjunctive therapy and monotherapy in infants and younger children was evaluated in 2 open-label pilot studies.
In one study, patients 1 month to [lt]4 years of age with partial seizures taking up to two concomitant antiepileptic drugs (AEDs) were assigned to one of 2 groups: 1) those receiving at least one enzyme-inducing AED (carbamazepine, phenobarbital or phenytoin); or 2) those receiving no AEDs or only non-enzyme-inducing AEDs.). Open-label dosing with oxcarbazepine 6% oral suspension was initiated at 10 mg/kg/day, and was increased by 10 mg/kg/day every 5 days to a maximum of 60 mg/kg/day for 30 days, followed by an optional 6-month extension. The second study included patients 1 month to 24 months of age with partial seizures hospitalized because of insufficient seizure control on their current baseline antiepileptic drug (AED) monotherapy (excluding phenobarbital, felbamate, benzodiazepines and zonisamide). On Day 1, treatment with oxcarbazepine 6% oral suspension was initiated at 20 mg/kg/day while the baseline AED dose was reduced by 50%. On Days 2-4, the baseline AED was discontinued, and oxcarbazepine was given at a dose of 40 mg/kg/day for 4-5 days, followed by an optional 6-month extension.
A total of 28 patients enrolled in the 2 studies (16 males, 12 females). The mean age was 19.6 ([plusmn]13.1) months. Five patients discontinued in one study: 3 patients due to adverse events (AEs) and 2 were lost to follow-up. The most frequent AEs ([gt]15%) were somnolence (25%), irritability (18%), and pyrexia (18%). No new safety findings (unexpected adverse events, laboratory parameters, physical examination, vital signs, ECG findings) were identified. Oxcarbazepine was well tolerated regardless of concomitant AED(s).
Oxcarbazepine (titrated from 10 to 60 mg/kg/day, over a period of approximately 4 weeks) was safe and well tolerated in patients 1 month to [lt]4 years of age.
[Supported by: Novartis Pharmaceuticals]