Rapid versus slow withdrawal of antiepileptic monotherapy in 2-year seizure-free adult patients with epilepsy (RASLOW) study: a pragmatic multicentre, prospective, randomized, controlled study

Sara Gasparini, Edoardo Ferlazzo, Giorgia Giussani, Domenico Italiano, Vittoria Cianci, Chiara Sueri, Edoardo Spina, Ettore Beghi, Umberto Aguglia

Research output: Contribution to journalArticle

Abstract

Antiepileptic drug withdrawal may be an option for patients who have been seizure free for some years. The best withdrawal rate is questionable; in particular, it is unknown whether “rapid” withdrawal is associated with a higher risk of relapse as compared to “slow” withdrawal. We aim to establish if a slow or a rapid withdrawal schedule of antiepileptic monotherapy influences relapse rate in adult patients with focal or generalized epilepsy who have been seizure free for at least 2 years. This multicentre, prospective, randomized controlled study will enroll adult patients with focal or generalized epilepsy, who are seizure free on monotherapy. Patients will be randomized to a slow (160 days) or a rapid (60 days) schedule. Follow-up will last 1 year after randomization. The primary endpoint is the time to seizure relapse; secondary endpoints are compliance to the assigned schedule, occurrence of status epilepticus, of seizure-related injuries and mortality. A sample size of 350 patients has been planned. Univariate and multivariate analysis by Kaplan–Meier curves and Cox regression (primary endpoint) and by logistic regression (secondary endpoint) will be performed. The present study should contribute to better define the best withdrawal period for AED treatment in adult patients with epilepsy.

Original languageEnglish
Pages (from-to)579-583
Number of pages5
JournalNeurological Sciences
Volume37
DOIs
Publication statusPublished - 2016

Keywords

  • Anti epileptic drug
  • Randomized controlled trial
  • Rapid withdrawal
  • Slow withdrawal

ASJC Scopus subject areas

  • Clinical Neurology
  • Psychiatry and Mental health
  • Dermatology

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