Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy (RASLOW)

University Magna Graecia

Status: Completed

Conditions: Epilepsy

Treatments: Drug: Rapid withdrawal of antiepileptic; Drug: Slow withdrawal of antiepileptic

Study type: Interventional

Funder types: Other

Identifiers

NCT05236166

GR-2013-02358677

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 16+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Rapid withdrawal

Other group

Description:

Reduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days).

Treatment:

Drug: Rapid withdrawal of antiepileptic

Slow withdrawal

Other group

Description:

Reduction by about 20 % of initial dosage every 40 days, until complete discontinuation (total withdrawal time: 160 days).

Treatment:

Drug: Slow withdrawal of antiepileptic