Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy

Overview

The main objective of the present study will be to establish whether a slow (within 160 days) or a rapid (within 60 days) withdrawal schedule of antiepileptic monotherapy influence relapse rate in adult patients with epilepsy, who have been seizure free for at least 2 years. Secondary objectives will be to establish the compliance rates with these two schedules and the differences in terms of severity of relapses, based on the occurrence of status epilepticus, seizure-related injuries and death.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 1, 2021

Interventions

  • Drug: Rapid withdrawal of antiepileptic
    • Reduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days). Drugs: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide
  • Drug: Slow withdrawal of antiepileptic
    • Slow withdrawal: reduction by about 20 % of initial dosage every 40 days, until complete discontinuation (total withdrawal time: 160 days). Drugs: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide

Arms, Groups and Cohorts

  • Other: Rapid withdrawal
    • Reduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days).
  • Other: Slow withdrawal
    • Reduction by about 20 % of initial dosage every 40 days, until complete discontinuation (total withdrawal time: 160 days).

Clinical Trial Outcome Measures

Primary Measures

  • Time to seizure relapse
    • Time Frame: 365 days
    • Time to recurrence of an epileptic seizure, assesed by telephone call and outpatients visits.

Secondary Measures

  • Patients’ compliance with the assigned withdrawal schedule
    • Time Frame: 365 days
    • Compliance with the assigned withdrawal schedule (evaluated by telephone interview) and outpatients visits.
  • Severity of relapses and mortality
    • Time Frame: 365 days
    • Severity of relapses, in terms of seizure-related injuries, status epilepticus (SE) during or after withdrawal period, and mortality

Participating in This Clinical Trial

Inclusion Criteria

  • diagnosis of focal or generalized epilepsy (according to International League Against Epilepsy 1989 criteria) – age at epilepsy onset of 16 years or older – seizure freedom for at least 2 years – treatment with one of the antiepilepsy drugs currently available for monotherapy in Italy: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid zonisamide) – adherence to the protocol and visit schedules. Exclusion Criteria:

  • inability to understand the aims or modalities of the study; – current pregnancy or plans to become pregnant during withdrawal period; – history of seizure relapse after discontinuation of treatment; – history of psychogenic non-epileptic seizures (PNES); – history of status epilepticus

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Magna Graecia
  • Collaborator
    • Ministry of Health, Italy
  • Provider of Information About this Clinical Study
    • Principal Investigator: Edoardo Ferlazzo, Professor – University Magna Graecia

References

Del Felice A, Beghi E, Boero G, La Neve A, Bogliun G, De Palo A, Specchio LM. Early versus late remission in a cohort of patients with newly diagnosed epilepsy. Epilepsia. 2010 Jan;51(1):37-42. doi: 10.1111/j.1528-1167.2009.02141.x. Epub 2009 Jun 1.

Ranganathan LN, Ramaratnam S. Rapid versus slow withdrawal of antiepileptic drugs. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005003. doi: 10.1002/14651858.CD005003.pub2.

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