NCT01147003已完成2 期
A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study Examining Seizure Frequency of BGG492 Capsules as Adjunctive Treatment in Patients With Partial Onset Seizures
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 93
- 试验地点
- 16
- 主要终点
- To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.
研究概览
简要总结
This study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients with partial onset seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients ≥ 50 kg (110 lb) of weight.
- •A diagnosis of epilepsy (≥ 2 years prior to screening) with partial seizures with or without secondarily generalized seizures.
- •Uncontrolled partial seizures despite having been treated with at least two different antiepileptic drugs (AEDs) within the last 2 years prior to screening.
- •At least 4 partial seizures during the 4-week baseline period and at least 4 partial seizures during the 4 weeks prior to the baseline period.
- •Cohort 1 patients must be receiving stable treatment with 1 or a maximum of 2 AEDs.Cohort 2 patients must be receiving stable treatment with 1, 2, or 3 AEDs.
排除标准
- •Presence of only non-motor simple partial seizures.
- •History of psychogenic seizures.
- •Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy.
- •Previous history of Lennox-Gastaut syndrome.
- •Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization.
- •Pregnant or nursing (lactating) women.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.
时间窗: 28 days
次要结局
- Pharmacokinetic profile of BGG492(10 weeks)
- To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period.(28 days)
- Safety and tolerability of BGG492 compared to placebo.(12 weeks)
- Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.(28 days)
研究者
研究点 (16)
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