| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
From Children’s Hospital, Department of Neurology, Cincinnati, OH (T.A.G.); Tallahassee Neurology Clinic, Tallahassee, FL (R.A.); Dallas Pediatric Neurology Associates, Dallas, TX (R.D.E.); Childrens Hospital Los Angeles and Keck School of Medicine of University of Southern California, Los Angeles, CA (W.G.M.); Primary Children’s Medical Center, University of Utah, Salt Lake City, UT (C.B.V.O.); and UCB Inc., Atlanta, GA (L.J.G., Z.L.).
Address correspondence and reprint requests to Dr. Tracy A. Glauser, Comprehensive Epilepsy Program, Children’s Hospital Medical Center, Department of Neurology, C-5, MLC 2015, 3333 Burnet Avenue, Cincinnati, OH 45229; e-mail: glauser{at}cchmc.org
Objective: To evaluate the efficacy and tolerability of levetiracetam (LEV) as adjunctive therapy in children (4 to 16 years) with treatment-resistant partial-onset seizures.
Methods: This multicenter, randomized, placebo-controlled trial consisted of an 8-week baseline period followed by a 14-week double-blind treatment period. During the treatment period, patients received either placebo or LEV add-on therapy and were up-titrated to a target dose of 60 mg/kg/day.
Results: One hundred ninety-eight patients (intent-to-treat population) provided evaluable data. The reduction in partial-onset seizure frequency per week for LEV adjunctive therapy over placebo adjunctive therapy was significant (26.8%; p = 0.0002; 95% CI 14.0% to 37.6%). A 50% or greater reduction of partial seizure frequency per week was attained in 44.6% of the LEV group (45/101 patients), compared with 19.6% (19/97 patients) receiving placebo (p = 0.0002). Seven (6.9%) LEV-treated patients were seizure-free during the entire double-blind treatment period, compared with one (1.0%) placebo-treated patient. One or more adverse events were reported by 88.1% of LEV-treated patients and 91.8% of placebo patients. The most common treatment-emergent adverse events were somnolence, accidental injury, vomiting, anorexia, hostility, nervousness, rhinitis, cough, and pharyngitis. A similar number of patients in each group required a dose reduction or withdrew from the study as a result of an adverse event.
Conclusion: Levetiracetam adjunctive therapy administered at 60 mg/kg/day is efficacious and well tolerated in children with treatment-resistant partial seizures.
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 June 13 issue to find the title link for this article.
This article was previously published in electronic format as an Expedited E-Pub on April 26, 2006, at www.neurology.org.
Disclosure: Sponsored by UCB Inc. L.J. Gauer and Dr. Lu are employees of and shareholders in UCB Inc. During the course of the study, Drs. Glauser, Ayala, Elterman, Mitchell, and Van Orman received grants from UCB Inc. in excess of $10,000; Drs. Glauser, Ayala, Elterman, and Van Orman have received personal compensation (honorarium) from the sponsor of the study (UCB Inc.) which did not exceed $10,000 per year during the course of the study. During the course of the study, Dr. Glauser received research support from NINDS, the Epilepsy Foundation, RWJ Pharmaceutical Research Institute (Johnson & Johnson), Pfizer, Novartis, Elan, and Eisai; he received honorarium and was a consultant to Elan, Ortho-McNeil, GlaxoSmithKline, Janssen-Cilag, Novartis, Xcel, Shire, Eisai, MedPointe, and Abbott. During the course of the study, Dr. Ayala was a consultant to Pfizer, Novartis, and GlaxoSmithKline. Dr. Elterman received honorarium and was a consultant to Novartis. Dr. Mitchell has received grants from Novartis, GlaxoSmithKline, Elan, Abbott, Parke-Davis/Pfizer, Ovation, and Johnson & Johnson in excess of $10,000. Dr. Van Orman has received grants from Elan, Novartis, and Abbott in excess of $10,000.
Received April 28, 2005. Accepted in final form February 22, 2006.
This article has been cited by other articles:
|
|
 |
|
  M. U. Farooq, A. Bhatt, A. Majid, R. Gupta, A. Khasnis, and M. Y. Kassab Levetiracetam for managing neurologic and psychiatric disorders Am. J. Health Syst. Pharm., March 15, 2009; 66(6): 541 - 561. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. Krief, Li Kan, and J. Maytal Efficacy of Levetiracetam in Children With Epilepsy Younger Than 2 Years of Age J Child Neurol, May 1, 2008; 23(5): 582 - 584. [Abstract] [PDF]
|
|
|
|
 |
|
 S. Noachtar, E. Andermann, P. Meyvisch, F. Andermann, W. B. Gough, J. Schiemann-Delgado, and For the N166 Levetiracetam Study Group Levetiracetam for the treatment of idiopathic generalized epilepsy with myoclonic seizures Neurology, February 19, 2008; 70(8): 607 - 616. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. F. Berkovic, R. C. Knowlton, R. F. Leroy, J. Schiemann, U. Falter, and On behalf of the Levetiracetam N01057 Study Group Placebo-controlled study of levetiracetam in idiopathic generalized epilepsy Neurology, October 30, 2007; 69(18): 1751 - 1760. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D.G.A. Kasteleijn-Nolst Trenite, P. Genton, D. Parain, P. Masnou, B. J. Steinhoff, T. Jacobs, E. Pigeolet, A. Stockis, and E. Hirsch Evaluation of brivaracetam, a novel SV2A ligand, in the photosensitivity model Neurology, September 4, 2007; 69(10): 1027 - 1034. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. Striano, A. Coppola, M. Pezzella, C. Ciampa, N. Specchio, F. Ragona, M. M. Mancardi, E. Gennaro, F. Beccaria, G. Capovilla, et al. An open-label trial of levetiracetam in severe myoclonic epilepsy of infancy Neurology, July 17, 2007; 69(3): 250 - 254. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. J. Brodie, E. Perucca, P. Ryvlin, E. Ben-Menachem, H.-J Meencke, and for the Levetiracetam Monotherapy Study Group Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy Neurology, February 6, 2007; 68(6): 402 - 408. [Abstract] [Full Text] [PDF]
|
|
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
