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.

DESIGN:

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.

CONCLUSION:

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: T A Glauser, M Nigro, R Sachdeo, L A Pasteris, S Weinstein, B Abou-Khalil, L M Frank, A Grinspan, T Guarino, D Bettis, J Kerrigan, G Geoffroy, D Mandelbaum, T Jacobs, P Mesenbrink, L Kramer, J D'Souza
• Journal: Neurology (Neurology) Vol. 54 Issue 12 Pg. 2237-44 (Jun 27 2000) ISSN: 0028-3878 [Print] United States
• PMID: 10881246 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• 10,11-dihydro-10-hydroxycarbamazepine
• Anticonvulsants
• Carbamazepine
• Oxcarbazepine

Topics

• Adolescent
• Anticonvulsants (adverse effects, pharmacokinetics, therapeutic use)
• Carbamazepine (adverse effects, analogs & derivatives, blood, pharmacokinetics, therapeutic use)
• Child
• Child, Preschool
• Double-Blind Method
• Electroencephalography
• Epilepsies, Partial (blood, drug therapy)
• Female
• Humans
• Male
• Oxcarbazepine
• Regression Analysis
• Treatment Outcome