2- YEAR LONG-TERM SAFETY AND EFFICACY DATA OF OXCARBAZEPINE IN CHILDREN WITH REFRACTORY PARTIAL EPILEPSY
Abstract number :
1.157
Submission category :
Year :
2002
Submission ID :
1501
Source :
www.aesnet.org
Presentation date :
12/7/2002 12:00:00 AM
Published date :
Dec 1, 2002, 06:00 AM
Authors :
Tracy A. Glauser, Rajesh C. Sachdeo, Martina Bebin, James W. Wheless, Joseph D[ssquote]Souza. Dept of Neurology, Children[ssquote]s Hospital Medical Center, Cincinnati, OH; Dept of Neurology, University of Medicine and Dentistry of New Jersey, New Brunswi
RATIONALE: To evaluate the 2-year long-term safety and efficacy of oxcarbazepine (OXC) during adjunctive therapy in children with inadequately controlled partial-onset seizures who had completed a double-blind, placebo-controlled phase.
METHODS: The randomized, double-blind, placebo-controlled, parallel-group trial consisted of a 56-day Baseline Phase during which patients (3-17 years) continued to receive treatment with 1-2 concomitant AEDs, a 112-day Double-blind Treatment Phase during which patients were randomized to adjunctive therapy with OXC or placebo, and an Open-label Extension Phase. Patients received OXC at an initial dose of 10 mg/kg/day titrated over 14 days to a target dose of 30-46 mg/kg/day or their maximum tolerated dose. Dose adjustments were performed in a blinded manner. During the Open-label Extension Phase the dose of OXC was titrated to clinical response. We report the 2-year safety and efficacy results.
RESULTS: A total of 233 children (53% males, 47% females) with a mean age of 11.2 years entered the Open-label Extension Phase, 128 (55%) of whom completed 2 years of open-label therapy. The reasons for exiting were unsatisfactory seizure control (25%), adverse events (7%), and other (13%). Compared to baseline, 53% of the patients experienced a [gt]50% reduction in seizure frequency and 4.7% were seizure-free throughout 104 weeks of open-label therapy. Throughout the 2-year period, the most common adverse events (incidence [gt]20%) reported were headache (37%), vomiting (36%), somnolence (33%), dizziness (32%), viral infection (27%), fever (24%), and upper respiratory infection (23%). Overall, the adverse events were mild and transient.
CONCLUSIONS: The results indicate that OXC maintains its efficacy as adjunctive therapy during long-term management of children with partial seizures.
[Supported by: Novartis Pharmaceuticals]; (Disclosure: Salary - D[ssqoute]Souza - Novartis Pharmaceuticals, Grant - Glauser, Sachdeo, Bebin, Wheless - Novartis Pharmaceuticals, Consulting - Glauser, Sachdeo - Novartis Pharmaceuticals, Honoraria - Glauser, Sachdeo - Novartis Pharmaceuticals)