Single-blind, placebo-controlled multicenter trial of vigabatrin in the treatment of epilepsy

C. Loeb, A. Iudice, E. Percucca, A. Gnanasakthy, F. Angeleri, O. Scarpino, G. Avanzini, D. Binelli, A. Baruzzi, G. Procaccianti, B. Bergamasco, C. Bianco, R. Canger, R. Mai, R. Di Perri, F. Pisani, L. Cocito, M. Manfredi, M. T. Faedda, R. MutaniM. Gianelli, A. Tartara, E. Perucca, C. A. Tassinari, R. Michelucci, R. Zappoli, G. Zaccara, A. Gnanasakthy, A. Iudice, J. Matthews, J. P. Mumford

Research output: Contribution to journalArticlepeer-review


A single-blind, placebo-controlled multicenter trial of vigabatrin was carried out in 101 epileptic patients (mostly with partial seizures) refractory to conventional therapy. The study design included four consecutive periods: (i) an observation phase (run-in), (ii) a placebo period, (iii) fixed-dosage add-on vigabatrin (2 g/day) and (iv) dose titration (up to a maximum of 4 g/day) to optimize clinical response. Each period lasted 8 weeks, except for the titration phase, which could be extended to 16 weeks. 90 patients completed the trial. Eleven dropped out, one patient developing absence status and 4 cases showing an increased seizure frequency. In the patients completing the trial, the median number of seizures/month decreased from 16 (inter-quartile range 8-34) during placebo to 5 (2-10) during the last 8 weeks on vigabatrin (p

Original languageEnglish
Pages (from-to)741-747
Number of pages7
JournalItalian Journal of Neurological Sciences
Issue number9
Publication statusPublished - Dec 1992


  • anticonvulsants
  • clinical trial
  • epilepsy
  • Vigabatrin

ASJC Scopus subject areas

  • Neuroscience(all)
  • Clinical Neurology


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