CTRI/2012/01/002344已完成3 期
A Randomized, Multicenter, Double-Blind, Placebo–Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of USL255 as Adjunctive Therapy in Patients with Refractory Partial-Onset Seizures.
UpsherSmith Laboratories Inc7 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2012年6月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 7
- 主要终点
- Percent reduction from baseline in weekly (7 day) partial-onset seizure frequency during the titration plus maintenance phase.
研究概览
简要总结
This is a Phase 3, randomized, multi-national, multicenter, double-blind, placebo–controlled, parallel group study designed to evaluate the efficacy and safety of USL255 as adjunctive therapy in subjects with refractory partial-onset seizures with or without secondary generalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to Visit
- •Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to Visit 1 (12 weeks for phenobarbital and primidone).
- •Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline.
排除标准
- •Have a history of seizure episodes lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished, within 3 months prior to Visit
- •Have a history of pseudoseizures, or status epilepticus, within 3 months prior to Visit
- •Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow angle glaucoma.
- •Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric illness within 2 years of Visit
- •Currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past.
- •Have taken topiramate within the past 6 months.
结局指标
主要结局
Percent reduction from baseline in weekly (7 day) partial-onset seizure frequency during the titration plus maintenance phase.
时间窗: Weekly (7 day)
次要结局
- Proportion of subjects with greater than or equal 50 percent reduction (responder rate) in weekly (7 day) partial-onset seizure frequency during the titration plus maintenance phase compared to baseline.(Weekly)
- Proportions of subjects with greater than or equal 50 percent reduction (responder rate) in weekly (7 day) partial-onset seizure frequency during the titration and maintenance phases, separately.(Weekly)
- Percent reductions from baseline in weekly (7 day) partial-onset seizure frequency during the titration and maintenance phases, separately.(Weekly)
- Percent reduction from baseline in weekly (7 day) all seizure frequency during the titration plus maintenance phase.(Weekly)
- Proportions of subjects with greater than or equal 25 percent, greater than or equal 75 percent, and 100 percent reduction in weekly (7 day) partial-onset seizure frequency during the titration, maintenance and titration plus maintenance phases, separately.(Weekly)
研究者
研究点 (7)
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