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 人开始时间: 2010年5月18日最近更新: 2016年8月16日

适应症

试验速览

暂无简介。

•- 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:
•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) no
•F.1.3.1 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

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