a 12-week, randomized, double-blind, placebo-controlled exploratory dose-titration study to assess the antiepileptic activity of BGG492 given orally three times daily (TID) as adjunctive treatment in patients with refractory partial onset seizures. - NA

ovartis Pharma Services AG0 个研究点目标入组 57 人2010年5月18日

概览

暂无简介。

注册库

who.int

开始日期

2010年5月18日

结束日期

待定

最后更新

9年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•\- male♀ outpatients age 18 to 65 years
•\- weight sup or equal to 50 kg
•\- have a diagnosis of epilepsy (more than 2 years before screening) with partial seizures
•\- must have at least 4 partial seizures during the 4\-week baseline period and the 4 weeks immediately preceding the baseline period
•\- have no 28\-day seizure\-free period during the 8 weeks preceding randomization
•\- must have a positive test result for iGluR3 antibodies in the blood at screening
•\- must have uncontrolled partial seizures despite having been treated with at least two different anti\-epileptic drugs within the last 2 years prior to screening
•\- must have received stable treatment with 1 or a max of 2 AED....
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\. Any of the following seizure conditions:
•\- presence of only non\-motor simple partial seizures
•\- history of psychogenic seizure
•\- abscences, myoclonic seizures
•\- previous history of Lennox\-Gastaut syndrome
•\- history of status epilepticus or seizure clusters
•\- only seizures caused by an underlying medical illness during the 52 weeks prior to randomization.
•2\. Have been treated with Vangabatrin, MAO inhibitors, Barbiturates, intermittent Benzodiazepines, L\-dopa formulations, concomitant use of potential inhibitors of OATP transporters