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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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
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
Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro
Reggio Calabria, Italy
Time to seizure relapse
Time to recurrence of an epileptic seizure, assesed by telephone call and outpatients visits.
Time frame: 365 days
Patients' compliance with the assigned withdrawal schedule
Compliance with the assigned withdrawal schedule (evaluated by telephone interview) and outpatients visits.
Time frame: 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
Time frame: 365 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.