Efficacy and tolerability of flexible dose adjusted pregabalin as first-line add-on treatment of patients with focal seizures - Pregabalin as first-line add-on

euro-Consil GmbH0 个研究点开始时间: 2007年4月18日最近更新: 2012年3月19日

研究概览

暂无简介。

•- informed consent in written form
•- men and women, 18-85 years of age
•- diagnosis of epilepsy according to criteria of the International Leage Against Epilepsy
•- at least 2 epileptic seizures prior to study inclusion
•- patients treated with 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
•- women without childbearing potential. As such are considered: 2 years postmenopausal or women following: bilateral ovariectomy, bilateral ligation of tubes or hysterectomy
•- women with childbearing potential practicing highly effective method of birth control. as such are considered: oral contraceptives with at least 50 microgram estrogen per tablet, hormonal intrauterin device (UID), male condom plus spermicide, female condom, monogamic sexual relationship with a vasectomised partner or sexual abstinence after consulting the sponsor
•- patients with impaired renal function (creatinine-clearance minor 60 and more than or right 30 ml/min) with adjustment of dosage according to the official producer information
•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 unable to understand the patient´s information and give informed consent
•- patients having participated in another clinical trial within the last 4 weeks prior to the study or currently participating
•- treatment with more than 2 well tolerated anticonvulsants of the first class (according to the DGN-guidelines 2005) prior to the study
•- patients actually or during last 3 months prior to the study treated with pregabalin
•- patients with known intolerance or severe effects during previous treatment with pregabalin
•- patients with a history of pseudo-seizures
•- patients with a history of status epilepticus
•- pregnant or breast-feeding women
•- 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 pancreatic or hepatic function
•- patients with impairment of renal function with a creatinine clearance minor 30 ml/min
•- 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)
•- 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