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Published online before print April 26, 2006, doi:10.1212/01.wnl.0000217916.00225.3a)
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Received April 28, 2005
Accepted February 22, 2006

Double-blind placebo-controlled trial of adjunctive levetiracetam in pediatric partial seizures

T. A. Glauser MD*, R. Ayala MD, R. D. Elterman MD, W. G. Mitchell MD, C. B. Van Orman MD, L. J. Gauer BS, Z. Lu MD, PhD, on behalf of the N159 Study Group

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.).


* To whom correspondence should be addressed. E-mail: glauser{at}cchmc.org.

Abstract-- 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.




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