A placebo-controlled trial of lamotrigine add-on therapy for partial seizures in children

M. Duchowny, J. M. Pellock, W. D. Graf, C. Billard, J. Gilman, E. Casale, G. Womble, M. Risner, P. Manasco

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108 Scopus citations

Abstract

Objective: To compare the safety and efficacy of add-on lamotrigine and placebo in the treatment of children and adolescents with partial seizures. Background: Add-on and monotherapy lamotrigine is safe and effective in adults with partial seizures, and reports of preliminary uncontrolled trials suggest similar benefits in children. Methods: We studied 201 children with diagnoses of partial seizures of any subtype currently receiving stable conventional regimens of antiepileptic therapy at 40 study sites in the United States and France. After a baseline observation period (to confirm that more than four seizures occurred in each of two consecutive 4-week periods), patients were randomized to add-on lamotrigine or placebo therapy. A 6-week dose-escalation period was followed by a 12-week maintenance period. Results: Compared with placebo, lamotrigine significantly reduced the frequency of all partial seizures and the frequency of secondarily generalized partial seizures in these treatment-resistant patients. The most commonly reported adverse events in the lamotrigine-treated patients were vomiting, somnolence, and infection; the frequency of these and other adverse events was similar to that in the placebo-treated group, with the exception of ataxia, dizziness, tremor, and nausea, which were more frequent in the lamotrigine-treated group. The frequency of withdrawals for adverse events was similar between groups. Two patients were hospitalized for skin rash, which resolved after discontinuation of lamotrigine therapy. Conclusions: Lamotrigine was effective for the adjunctive treatment of partial seizures in children and demonstrated an acceptable safety profile.

Original languageEnglish
Pages (from-to)1724-1731
Number of pages8
JournalNeurology
Volume53
Issue number8
StatePublished - Nov 10 1999

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Keywords

  • Epilepsy
  • Lamotrigine
  • Partial seizures
  • Pediatric

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

Duchowny, M., Pellock, J. M., Graf, W. D., Billard, C., Gilman, J., Casale, E., Womble, G., Risner, M., & Manasco, P. (1999). A placebo-controlled trial of lamotrigine add-on therapy for partial seizures in children. Neurology, 53(8), 1724-1731.