NCT01167335撤回2 期
A 12-week, Randomized, Double-blind, Placebo-controlled Exploratory Study to Assess the Antiepileptic Activity of BGG492 Given Orally as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Novartis
- 试验地点
- 5
- 主要终点
- Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.
研究概览
简要总结
This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory 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 AEDs within the last 2 years prior to screening.
- •Treated with a stable dose of 1-2 AEDs
- •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.
- •No 28-day seizure-free period during the 8 weeks preceding randomization
- •Positive biomarker screening
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
- •Pregnant or nursing (lactating) women
- •Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
BGG492
Experimental
干预措施: BGG492 (Drug)
结局指标
主要结局
Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.
时间窗: 28 days
次要结局
- Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.(28 days)
- Safety and tolerability of BGG492 compared to placebo evaluated by continuous adverse event monitoring and assessment of vital signs and ECGs at each visit and laboratory assessments every 2 to 4 weeks(12 weeks)
- Pharmacokinetic profile of BGG492 including plasma concentrations of BGG492 at each dose level and derived variables including AUC (area under the curve), Cmax (maximum plasma concentration), Tmax (time to maximum concentration), T1/2 (half life.)(10 weeks)
研究者
研究点 (5)
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