Efficacy and tolerability of vigabatrin in children with refractory partial seizures: A single-blind dose-increasing study

B. D. Bernardina, E. Fontana, F. Vigevano, L. Fusco, D. Torelli, D. Galeone, D. Buti, C. Cianchetti, A. Gnanasakthy, A. Iudice

Research output: Contribution to journalArticle

Abstract

The efficacy and tolerability of vigabatrin (VGB) in children with refractory partial epilepsy were assessed in a single-blind, add-on, fixed- sequence, placebo-controlled trial. After 1-month observation, the patients entered a 7-month treatment period that involved administration of placebo for 1 month followed by VGB at the initial dosage of 40 mg/kg/day, to be increased to 60 and 80 mg/kg/day at 2-month intervals if seizures persisted. Of the 46 children enrolled in the study, 7 dropped out prematurely due to lack of efficacy of the drug (n = 6) or increased seizure frequency (n = 1). In 11 patients who either became seizure-free (n = 3) or improved markedly (n = 8), treatment was completed at a dose 50% reduction in seizure frequency after 2, 4, and 6 months was 28, 33, and 35, respectively. Eight patients became seizure- free during the last 2 months of VGB treatment (3 at 40, 3 at 60, and 2 at 80 mg/kg/day, as compared with none during placebo treatment). Serum levels of associated antiepileptic drugs (AEDs) showed no significant changes, except for serum phenytoin (PHT) concentration, which significantly (p <0.01) decreased after VGB treatment. Increased appetite and sedation were observed in 17 and 11% of cases, respectively. VGB is effective in the management of refractory partial epilepsy in children, and in some patients a positive dose-response relationship appears to occur over the assessed dosing range.

Original languageEnglish
Pages (from-to)687-691
Number of pages5
JournalEpilepsia
Volume36
Issue number7
DOIs
Publication statusPublished - 1995

Keywords

  • Children
  • Clinical trial
  • Epilepsy
  • Vigabatrin

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)

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    Bernardina, B. D., Fontana, E., Vigevano, F., Fusco, L., Torelli, D., Galeone, D., Buti, D., Cianchetti, C., Gnanasakthy, A., & Iudice, A. (1995). Efficacy and tolerability of vigabatrin in children with refractory partial seizures: A single-blind dose-increasing study. Epilepsia, 36(7), 687-691. https://doi.org/10.1111/j.1528-1157.1995.tb01047.x