A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 116
- 主要终点
- Responder Rate for total partial onset seizures as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)
研究概览
简要总结
To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Other neuropsychological clinical assessments will be performed during the 34 day length of the study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Month 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients from 1 month to less than 4 years of age
- •Pediatric patients diagnosed with refractory partial onset seizures, on a stable regimen of one to two other anti-epileptic drugs and at least 2 partial onset seizures per week in the two weeks prior to screening
- •Patients must have two partial onset seizures (with corresponding clinical event) during the 48-hour video EEG at screening
排除标准
- •A ketogenic diet
- •Previous exposure to levetiracetam
- •Seizures too close together to count accurately
- •Treatable seizure etiology
- •Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease
- •Diagnosis of a terminal illness
研究组 & 干预措施
Levetiractem
10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
干预措施: Levetiracetam (Drug)
Placebo
Matching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
干预措施: Placebo (Other)
结局指标
主要结局
Responder Rate for total partial onset seizures as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)
时间窗: 48-hours in Evaluation Period and 48-hours in Selection Period
Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for partial onset seizures divided by the total number of subjects. If a subject had \< 24 hours of usable Evaluation video-EEG time (including zero time available) and withdrawal from the study with reasons linked to lack or loss of efficacy, the subject was counted as a non-responder.
次要结局
- Percent reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG(48-hours in Evaluation Period and 48-hours in Selection Period)
- Absolute reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG(48-hours in Evaluation Period and 48-hours in Selection Period)
- Percentage of drop-outs before 24 hours of Evaluation video-EEG for reasons other than lack or loss of efficacy(During the study (up to 20 days))
- Time to Exit (TTE) during the Evaluation Period(During Evaluation Period (Day 1 to Day 6))
- Responder rate for total seizures (all types) as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)(48-hours in Evaluation Period and 48-hours in Selection Period)
- Percent reduction in Average Daily Frequency (ADF) of electro-clinical partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG for children 1 month to less than 6 months old(48-hours in Evaluation Period and 48-hours in Selection Period)
- Percentage of drop-outs for any reasons during the study(During the study (up to 20 days))
- Percent reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG(48-hours in Evaluation Period and 48-hours in Selection Period)
- Absolute reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG(48-hours in Evaluation Period and 48-hours in Selection Period)
- Percentage of drop-outs due to lack of efficacy during the study(During the study (up to 20 days))