A 52 Weeks, Open-Label, Multicenter Study Evaluating The Efficacy And Safety Of Gabapentin As Adjunctive Therapy In Pediatric Patients Who Have Completed The 12 Weeks Treatment In Study A9451162 (NCT00603473)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
研究概览
简要总结
Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of study A9451162 (NCT00603473)
排除标准
- •Seizures related to drugs or acute medical illness
- •History of any serious medical or psychiatric disorder
研究组 & 干预措施
gabapentin
干预措施: gabapentin (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
时间窗: up to 53 weeks
Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.
次要结局
- Response Ratio(Up to 52 weeks)
- Responder Rate(Up to 52 weeks)
- Percent Change in Seizure Frequency(Up to 52 weeks)