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Completed

NCT Number: NCT05236166

Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro

Reggio Calabria, 89100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid withdrawal of antiepileptic

Drug

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

Other names: antiepileptic

Slow withdrawal of antiepileptic

Drug

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

Other names: antiepileptic

Primary outcomes

  1. Time to seizure relapse

    Time frame: 365 days

    Time to recurrence of an epileptic seizure, assesed by telephone call and outpatients visits.

Secondary outcomes

  1. Patients' compliance with the assigned withdrawal schedule

    Time frame: 365 days

    Compliance with the assigned withdrawal schedule (evaluated by telephone interview) and outpatients visits.

  2. 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

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Collaborators

  • Ministry of Health, Italy

Registry information

Official study title

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

Acronym: RASLOW

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2022
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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