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From Vanderbilt Children’s Hospital (Dr. Piña-Garza), Pediatric Neurology, Nashville, TN; The Hospital Infantil de Mexico (Dr. Espinoza), Instituto Nacional de Salud Federico Gomez, Col Doctores Delegacion Cuauhtemoc, Mexico; The Children’s Epilepsy Center (Dr. Nordli), Children’s Memorial Hospital, Chicago, IL; Clinical Research and Development (Drs. Bennett and Stites, and S. Spirito) and Biostatistics and Statistical Reporting (Dr. Tang), Novartis Pharmaceuticals Inc., East Hanover, NJ; and Novartis Pharma AG (Dr. Sturm), Basel, Switzerland.
Address correspondence and reprint requests to Dr. Jesus Eric Piña-Garza, Vanderbilt Children’s Hospital, Pediatric Neurology, 2200 Children’s Way, Room 11244, Nashville, TN 37232; e-mail: eric.pina-garza{at}vanderbilt.edu
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 (
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.
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the November 8 issue to find the title link for this article.
Editorial, see page 1348
Disclosure: J.E.P.-G. serves as a consultant and speaker for Novartis Pharmaceuticals Inc. D.N. serves as a consultant for and has received honoraria in excess of $10,000 from Novartis Pharmaceuticals Inc. D.B., S.S., T.S., and D.T. are employees of Novartis Pharmaceuticals Inc. and D.T. and D.B. are stockholders in Novartis Pharmaceuticals Inc. Y.S. is an employee and stockholder in excess of $10,000 in Novartis Pharma AG. R.E. has no financial interests to disclose. This study was sponsored by Novartis Pharmaceuticals Inc.
Received January 6, 2005. Accepted in final form August 15, 2005.
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  H. P. Goodkin and M. L. Buck Still orphans: Antiepileptic drug trials in children under 2 years of age Neurology, May 27, 2008; 70(22_Part_2): 2093 - 2094. [Full Text] [PDF]
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S. P. Kruszewski, S. G. Klotz, J .E. Pina-Garza, R. Espinoza, D. Nordli, D.A. Bennett, S. Spirito, T.E. Stites, D. Tang, and Y. Sturm Oxcarbazepine adjunctive therapy in infants and young children with partial seizures Neurology, February 6, 2007; 68(6): 472 - 473. [Full Text] [PDF]
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S. Shinnar and J. M. Pellock The trials and tribulations of pediatric drug trials Neurology, November 8, 2005; 65(9): 1348 - 1349. [Full Text] [PDF]
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