A 12-week, multi-center,randomized, double-blind, placebo-controlled efficacy and safety study examining seizure frequency of BGG492 capsules administration orally three times daily (TID) as adjunctive treatment in patients with partial onset seizures.

ovartis Pharma Services AG0 个研究点目标入组 81 人开始时间: 2010年3月19日最近更新: 2012年10月22日

研究概览

暂无简介。

•Key inclusion criteria:
•- male or female
•- weight sup or equal to 50kg
•- Have a diagnosis of epilepsy (= 2 years prior to screening) with partial seizures with or
•without secondarily generalized seizures according to the International League Against
•Epilepsy’s Classification of Epileptic Seizures (ILAE, 1981); Appendix 5;
•The diagnosis should have been established by clinical history and abnormal
•electroencephalogram (EEG) that is consistent with localization-related epilepsy (For
•Cohort 1 an abnormal EEG must be dated > 2 years prior screening for inclusion. For
•Cohort 2, an abnormal EEG is acceptable at any time prior to screening provided that
•clinical history documents localization-related epilepsy along with AED treatment for > 2
•years prior to screening).
•- have uncontrolled partial seizures
•- have at least 4 partial seizures
•- have no 28-day seizure-free period during the 8 weeks preceding randomization
•- Cohort 1 patients must be receiving stable treatment (see inclusion criteria 8.1-8.4 and 9) with 1 or a maximum of 2 AEDs ; whereas, Cohort 2 patients must be receiving stable treatment with 1, 2, or 3 AEDs
•please refer to protocol for the full list
•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

•Key exclusion criteria:Any of the following seizure conditions:
•- Presence of only non-motor simple partial seizures
•- History of psychogenic seizures within 52 weeks prior to screening;
•- Absences and/or myoclonic seizures e.g. in the context of primarily generalized epilepsy
•- Previous history of Lennox-Gastaut syndrome
•- Status epilepticus or seizure clusters where individual seizures cannot be counted according to the judgement of the investigator occuring within 52 weeks prior to randomization.
•please refert to protocol for the full list

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