Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Rapid withdrawal of antiepileptic
* Drug: Slow withdrawal of antiepileptic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rapid withdrawal<br>Reduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days). | Drug: Rapid withdrawal of antiepileptic<br>* 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<br>* Other names: antiepileptic;|
| Other: Slow withdrawal<br>Reduction by about 20 % of initial dosage every 40 days, until complete discontinuation (total withdrawal time: 160 days). | Drug: Slow withdrawal of antiepileptic<br>* 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<br>* Other names: antiepileptic;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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