EUCTR2006-004355-38-IT进行中（未招募）不适用
Multicenter, comparative, randomized, open trial to evaluate efficacy and safety of Levetiracetam versus Carbamazepine in post stroke late onset crisis - ND
ASSOCIAZIONE S.N.O.- SCIENZE NEUROLOGICHE OSPEDALIERE0 个研究点开始时间: 2006年12月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 3 aged 8805; 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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 status epilepticus 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 dysfagia 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
研究者
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