An Open Label, Exploratory, Dose-escalation, Multicenter Study Examining the Safety, Tolerability and Efficacy of Ucb 44212 (Seletracetam) Used at Doses of 10, 20, 40, and 80 mg b.i.d. (Total Daily Doses of 20 - 160 mg) Administration (Oral Capsules) in Adult Subjects (18 - 65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures Who Are Currently Receiving Levetiracetam (LEV) But Still Experiencing Seizures
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 主要终点
- Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
研究概览
简要总结
This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)
- •Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized
- •Subjects who have been treated for epilepsy for >= 6 months and are currently uncontrolled while being treated with 1-3 concomitant AED(s), inclusive of levetiracetam (LEV)
- •Female subjects without childbearing potential or those who are using an acceptable contraceptive method
排除标准
- •Seizures occurring in clusters. Status epilepticus within 6 months of Visit
- •History of non-epileptic seizures
- •Subjects on vigabatrin
- •Subjects on felbamate, unless treatment has been continuous for >2 years
- •Ongoing psychiatric disease other than mild controlled disorders
- •Subjects with clinically significant organ dysfunction
- •Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
- •Pregnant or lactating women
- •Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant Antiepileptic Drug (AEDs).
研究组 & 干预措施
Seletracetam
Escalating doses twice daily were to be administered.
干预措施: Seletracetam (UCB44212) (Drug)
结局指标
主要结局
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
时间窗: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
次要结局
- Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period(During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4))
- Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period(During the Treatment Period (Week 5 to Week 15))
- Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period(During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4))
- Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period(During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4))
- Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period(During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4))
- Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period(During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4))
- Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period(During the Treatment Period (Week 5 to Week 15))
- Percentage of Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period(During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4))