Comparison of efficacy and tolerability of rapid intravenous infusion of levetiracetam and sodium valproat. - Levetiracetam i.v.

euro-Consil GmbH0 个研究点开始时间: 2006年9月8日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Men and women, 18-80 years of age
•- Diagnosis of epilepsy according to criteria of the International League Against Epilepsy
•- occurrence of one epileptic seizure if patient and neurologist consider anticonvulsant protection necessary
•- patients treated with no, one or two anticonvulsants, benzodiazepine emergency medication may be applied additionally prior to the study
•- patients must be able to understand and comply with the study protocol and fill out a seizure diary
•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

•- patients having participated in another clinical trial within last 2 weeks prior to the study
•- patients unable to understand patient's information and give informed consent
•- pregnant or breast-feeding women
•- treatment with levetiracetam or valproic acid within last 2 weeks prior to the study.
•- patients being treated with more than 200 mg Lamotrigine/d
•-patients with a known hypersensitivity or severe unexpected events during prior treatment with either levetiracetam or valproic acid
•- patients with a history of pseudo-seizures
•- patients with a history of status epilepticus
•- women who do not practice a reliable method of birth control
•- patients suffering any severe, progressive or potentially life-threatening disease
•- patients with clinically important impairment of renal, pancreatic or hepatic function
•- patients with a history of alcoholism or drug abuse
•- patients with a severe psychiatric disease, especially when suicidal. Exception: Mild or medium degree depression without suicidal tendency or history of attempted suicide
•- patients with abnormal laboratory evaluations if considered clinically significant by the investigator
•- patients who are dependent on the sponsor or investigator

发起方

euro-Consil GmbH