NCT04558580撤回3 期
A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percentage change in total partial seizure frequency from baseline.
研究概览
简要总结
This study will evaluate the efficacy and safety of Rufinamide in reducing seizure frequency in subjects with partial seizures not fully controlled despite treatment with 1 to 3 concomitant antiepileptic drugs.
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
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female patients between 12 and 80 years of age
- •Dx of epilepsy with partial onset seizures woth or woth out secondarily generalized seizures
- •Non controlled partial seizures despite treatment with 2 different AEDs for at least 2 years
- •must have 6 seizures during baseline
- •current treatment with maximum of 3 AEDs
- •stable dose of AED(s)for at least 1 month
- •if patient has VNS, must have been implanted 6 months prior to randomization
排除标准
- •Participation in any investigational product for at least 1 month prior to visit 1
- •Presence of non-motor simple partial seizures only
- •presence of generalized epilepsies
- •Evidence of clinically significant disease
- •Clinically significant ECG
- •Psychogenic seizure in previous year
- •History of drug/alcohol abuse
- •History of suicide attempt
- •Multiple drug allergies
- •Concomitant felbamate use
- •Need for frequent rescue benzodiazepines
- •Concomitant use of vigabatrin
- •All patients diagnosed with congenital short QT syndrome
研究组 & 干预措施
Rufinamide
Experimental
干预措施: Rufinamide (Drug)
结局指标
主要结局
Percentage change in total partial seizure frequency from baseline.
时间窗: 22 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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