NCT00603473已完成3 期
An Open-Label, Multicenter Study Evaluating, The Efficacy, Safety And Pharmacokinetics Of Gabapentin As Adjunctive Therapy In Pediatric Patients With Partial Seizures When Other Antiepileptics Do Not Provide Satisfactory Effects
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures
研究概览
简要总结
Examine the efficacy, safety and pharmacokinetics 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 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese male or females, ages 3-15 years old at acquisition of informed consent, 15 years old or less at the baseline visit
- •Seizures are classified as simple partial, complex partial or partial becoming secondarily generalized (defined according to the International League Against Epilepsy)
- •Have not been able to achieve adequate seizure control with antiepileptic drugs
排除标准
- •Seizures related to drugs or acute medical illness
- •History of any serious medical or psychiatric disorder
- •Diagnosis or history of a structural CNS lesion or an encephalopathy shown to be progressive
研究组 & 干预措施
gabapentin
Experimental
干预措施: gabapentin (Drug)
结局指标
主要结局
Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures
时间窗: 12 weeks
The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T-B) / (T+B) where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.
次要结局
- Responder Rate(12 weeks)
- Percent Change in Seizure Frequency (PCH)(12 weeks)
研究者
研究点 (1)
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