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 journalArticle

Abstract

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
Volume13
Issue number9
DOIs
Publication statusPublished - Dec 1992

Keywords

  • anticonvulsants
  • clinical trial
  • epilepsy
  • Vigabatrin

ASJC Scopus subject areas

  • Neuroscience(all)
  • Clinical Neurology

Fingerprint Dive into the research topics of 'Single-blind, placebo-controlled multicenter trial of vigabatrin in the treatment of epilepsy'. Together they form a unique fingerprint.

  • Cite this

    Loeb, C., Iudice, A., Percucca, E., Gnanasakthy, A., Angeleri, F., Scarpino, O., Avanzini, G., Binelli, D., Baruzzi, A., Procaccianti, G., Bergamasco, B., Bianco, C., Canger, R., Mai, R., Di Perri, R., Pisani, F., Cocito, L., Manfredi, M., Faedda, M. T., ... Mumford, J. P. (1992). Single-blind, placebo-controlled multicenter trial of vigabatrin in the treatment of epilepsy. Italian Journal of Neurological Sciences, 13(9), 741-747. https://doi.org/10.1007/BF02229159