A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-24 Months of Age) With Refractory Partial-Onset Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 118
- 主要终点
- Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader
研究概览
简要总结
The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).
详细描述
This is a world wide, multicenter, randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety and efficacy of 3 target doses (5, 15, and 25 mg/kg/day) of topiramate compared with placebo as an adjunct therapy in infants with refractory partial onset seizures (POS). There are 4 phases to the study, a screening phase of 3 days, a double blind treatment phase of 20 days, a one year open label extension phase and a posttreatment (taper and withdrawal) phase. The oral liquid formulation will also be assessed during this study, as it is investigational, unlike the marketed sprinkle formulation. 5, 15, 25 mg/kg/day of topriramate sprinkle and oral liquid formulation will be administered during the four phases 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1-24 months, inclusive
- •Concurrent 1 or 2 antiepileptic drugs
- •Receiving regular enteral feedings
- •Weigh between 3.5 and 15 kg
- •Clinical or EEG evidence of simple or complex POS
排除标准
- •Exclusively breast fed and cannot take medicine by mouth
- •Surgically implanted and functioning vagus nerve stimulator
- •Renal stones
- •Medically uncontrolled illnesses or conditions
- •Infantile seizures as a result of a correctable medical condition
- •Progressive neurologic disorder
研究组 & 干预措施
003
topiramate 25 mg/kg/day
干预措施: topiramate (Drug)
002
topiramate 15 mg/kg/day
干预措施: topiramate (Drug)
001
topiramate 5 mg/kg/day
干预措施: topiramate (Drug)
004
placebo placebo
干预措施: placebo (Drug)
结局指标
主要结局
Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader
时间窗: Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader
次要结局
- Percent treatment responders >=50% reduction seizure rate. ·Percentage change in seizure rate recorded on subject take-home records. Percentage change in seizure rates for all seizure types recorded on VEEG.(Baseline to endpoint of double blind phase)