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

Neurological Sciences : Official Journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
Sara GaspariniUmberto Aguglia

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...Continue Reading

References

Jan 1, 1992·European Neurology·C MastropaoloF Zoroddu
Apr 14, 1988·The New England Journal of Medicine·N CallaghanT Goggin
Nov 1, 1987·Epilepsy Research·J S Duncan, S D Shorvon
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Aug 30, 2002·Epilepsia·Ettore BeghiUNKNOWN RESt-1 Group
Mar 16, 2004·CNS Drugs·Luigi M Specchio, Ettore Beghi
Jun 6, 2009·Epilepsia·Alessandra Del FeliceLuigi M Specchio

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Citations

Aug 4, 2016·Expert Review of Neurotherapeutics·Johan A F KoekkoekMartin J B Taphoorn
Jan 18, 2017·Neurological Sciences : Official Journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology·Ilaria Di Donato, Antonio Federico
Jan 29, 2020·The Cochrane Database of Systematic Reviews·Fernando Ayuga LoroFrancesco Brigo

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