NCT05236166

Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University Magna Graecia · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Rapid withdrawal of antiepileptic	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
DRUG	Slow withdrawal of antiepileptic	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

Timeline

• Start date: 2017-04-26
• Primary completion: 2021-05-01
• Completion: 2021-11-01
• First posted: 2022-02-11
• Last updated: 2022-02-11

Locations

1 site across 1 country: Italy