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

OVARTIS FARMA0 个研究点目标入组 168 人开始时间: 2010年4月8日最近更新: 2012年6月12日

适应症

试验速览

暂无简介。

•Key inclusion criteria: ? Male and female outpatients age 18 to 65 years (inclusive) ? Weight of ≥ 50 kg (110 lb) ? 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 ? Have uncontrolled partial seizures despite having been treated with at least two different antiepileptic drugs within the last 2 years prior to screening (given concurrently or sequentially) ? Have at least 4 partial seizures (defined as simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with secondary generalization or a combination of these types for this inclusion criterion) during the 4-week baseline period and the 4 weeks immediately preceding the baseline period (retrospective and/or prospective data) ? Have no 28-day seizure-free period during the 8 weeks preceding randomization. ? Must be receiving stable treatment with 1 or a maximum of 2 AEDs
•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 Psychogenic seizures Absences and/or myoclonic seizures e.g. in the context of primary generalized epilepsy; Previous history of Lennox-Gastaut syndrome Status epilepticus or seizure clusters where individual seizures cannot be counted according to the judgment of the investigator occurring within 52 weeks prior to randomization

发起方