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


CONCLUSIONS
Levetiracetam adjunctive therapy administered at 60 mg/kg/day is efficacious and well tolerated in children with treatment-resistant partial seizures.
Glauser
T A
TA
Children's Hospital, Department of Neurology, Cincinnati, OH 45229, USA. glauser@cchmc.org
Ayala
R
R
Elterman
R D
RD
Mitchell
W G
WG
Van Orman
C B
CB
Gauer
L J
LJ
Lu
Z
Z
D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004828:Epilepsies, Partial / Q000175:diagnosis* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D010372:Pediatrics / Q000379:methods; D010889:Piracetam / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D015990:Placebo Effect; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome
D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam