Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy

• Status: Completed
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Magna Graecia
• Collaborator: Ministry of Health, Italy
• Treatments: Anticonvulsants

Criteria

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