Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05236166

Acronym

RASLOW

Enrollment

Registered

2022-02-11

Start date

2017-04-26

Completion date

2021-11-01

Last updated

2022-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Brief summary

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.

Interventions

DRUGRapid 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

DRUGSlow 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Time to seizure relapse	365 days	Time to recurrence of an epileptic seizure, assesed by telephone call and outpatients visits.

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026