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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Time to seizure relapse
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Rapid withdrawal
Reduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days).
干预措施: Rapid withdrawal of antiepileptic (Drug)
Slow withdrawal
Reduction by about 20 % of initial dosage every 40 days, until complete discontinuation (total withdrawal time: 160 days).
干预措施: Slow withdrawal of antiepileptic (Drug)
结局指标
主要结局
Time to seizure relapse
时间窗: 365 days
Time to recurrence of an epileptic seizure, assesed by telephone call and outpatients visits.
次要结局
- Patients' compliance with the assigned withdrawal schedule(365 days)
- Severity of relapses and mortality(365 days)
研究者
Edoardo Ferlazzo
Professor
University Magna Graecia