A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 68
- 主要终点
- Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
研究概览
简要总结
This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have 3 partial onset seizures in the month prior to screening.
- •Subject must have 2 partial onset seizures during the 48 hour baseline phase.
- •Signed Informed Consent.
- •On 1-3 stable anti-epileptic drugs at screening.
排除标准
- •Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms.
- •Lennox-Gasteau, BECTS, and Dravet's syndrome.
- •Status epliepticus within 1 year of screening.
- •Any change in AED regimen with 7 days of screening.
- •Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy.
- •Progressive errors of metabolism.
研究组 & 干预措施
Study Drug Level 1
干预措施: Pregabalin Dose Level 1 (Drug)
Study Drug Level 2
干预措施: Pregabalin Dose Level 2 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
时间窗: Day 1 up to Day 14
All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = (\[Number of seizures in double blind 48 to 72 hour EEG assessment\] divided by \[number of hours of video-EEG monitoring\])\*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1).
次要结局
- Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase(Day 1 up to Day 14)