Multicenter, Comparative, Randomized, Open Trial to Evaluate Efficacy and Safety of Levetiracetam Versus Carbamazepine in Post Stroke Late Onset Crisis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 630
- 试验地点
- 24
- 主要终点
- number of patients free from post stroke recurrent crisis
研究概览
简要总结
The principal purpose of the study is to determine the efficacy and safety of Levetiracetam versus Carbamazepine, intended as the number of patients free from crisis during the whole period of treatment, in patients affected by post stroke late onset crisis.
详细描述
Stroke is the most common cause of seizures in the elderly and seizures are among the most common sequelae of stroke.
About 10% of patients experience seizures since stroke onset up to several years (Silverman 2002). Arbitrarly a cut point of 2 weeks divide early seizures from late seizures (Honey 2000, Olofson 2000, Berger 1989).Late occurrence of late seizure appears to carry a high risk for epilepsy (Wilmore 1990).
The risk of epilepsy in some patients with a single stroke-related seizure is high enough to justify starting an anticonvulsant therapy before a second seizure occurs(Labovitz 2003).
Levetiracetam (S-α-ethil-2-oxo-pyrrolidine acetamide) is S-enantiomer of a pyrrolidine derivative and is unrelated to any other AED and has a unique preclinical and clinical profile (Gower et al 1992).
Levetiracetam (LEV) binds with a stereospecific binding site in the CNS that is saturable and reversible (Noyer 1995). This site actually known as LBS Levetiracetam Binding Site) is unique and do not correspond to any known receptor or channel that might be involved in neuroexcitability (Gillard 2003).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having a stroke (ischemic and haemorrhagic) showing (one) subsequent seizure 14 days up to 3 years after stroke
- •Patients has signed the informed consent form
- •Aged ≥ 18 years
排除标准
- •Severe stroke patients with Rankin scale > 3
- •Patients with a life expectancy of < 12 months
- •Patients screened more than 15 days after first seizure
- •Patients with a diagnosed epilepsy
- •Patients with clear evidence of myoclonic seizures
- •Patients with contraindication to levetiracetam and carbamazepine use
- •Patients presenting epileptic status at onset
- •Patients having a MMSE <24
- •Patients having a seizure before stroke
- •Patients taking any AED 4 weeks prior to randomisation in the study
- •Patients showing dysphagia after stroke not able to swallow tablets.
- •Patients with a low compliance for the study
- •Pregnant women, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method.
- •Allergy or intolerance to pyrrolidine derivatives and/or tablet excipients or to carbamazepine derivates and /or tablet excipients
- •Patients involved in another clinical trial 30 days prior randomization
- •Patients with any tumour
- •Patients with previous traumatic brain accident resulting in impairment of consciousness.
- •Patients for whom it is not possible to assess seizure onset
研究组 & 干预措施
LEV
Levetiracetam
干预措施: Levetiracetam (Drug)
CAR
Carbamazepina
干预措施: Carbamazepine (Drug)
结局指标
主要结局
number of patients free from post stroke recurrent crisis
时间窗: one year
次要结局
- To compare retention time of LEV vs CBZ since first intake throughout treatment period(one year)
- To compare time to second seizure in both treatments.(one year)
- To evaluate differences in cognitive function and in quality of life in levetiracetam and carbamazepine patients having post-stroke seizures at the end of treatment period(one year)
- evaluate EEG changes as compared with baseline with that obtained at the end of treatment period(one year)
- To compare seizure frequency in levetiracetam and carbamazepine groups throughout treatment period(one year)
- To evaluate the safety of levetiracetam versus carbamazepine throughout the treatment period(one year)