Status:
COMPLETED
Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy
Lead Sponsor:
University Magna Graecia
Collaborating Sponsors:
Ministry of Health, Italy
Conditions:
Epilepsy
Eligibility:
All Genders
16+ years
Phase:
NA
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 adu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05236166
Start Date
April 26 2017
End Date
November 1 2021
Last Update
February 11 2022
Active Locations (1)
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1
Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro
Reggio Calabria, Italy, 89100