NCT01051193已完成2 期
A Multicentre, Open-label, Extension Study in Children With Inadequately Controlled Partial Onset Seizures to Investigate Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) as Adjunctive Therapy
Nobelpharma1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2010年1月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG))
研究概览
简要总结
This study is designed to provide long term safety data of TRI476 in children with inadequately-controlled partial seizures. This study is conducted in patients who complete the core study CTRI476B1301. Blinding is maintained during the transition and dose adjustment phase of the extension study. All patients are treated with TRI476 from the dose adjustment phase onwards. The purpose of study is to confirm that TRI476 as adjunctive therapy is safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who completed the double-blind treatment phase of the core study (B1301).
- •A parent/legal guardian must be present and give written consent for all patients enrolled in this trial. Patients consent must be obtained using assent document according to patients age.
- •Females of childbearing potential must have a negative pregnancy test at Week 8 in the core study B1301.
排除标准
- •Patients with medical ineligibility to enter the extension, as assessed by the investigator at each site.
- •Patients who participated in the core study, but did not complete it (prematurely discontinued)
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
TRI476
Experimental
TRI476
干预措施: Oxcarbazepine (Drug)
结局指标
主要结局
Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG))
时间窗: 52 weeks and until approval/launch
次要结局
- Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period(52 weeks and until approval/launch)
- Seizure Frequency of specific duration(52 weeks and until approval/launch)
- Responder rate: defined as the proportion of patients with an at least 50% reduction in the partial epileptic seizure frequency(52 weeks and until approval/launch)
- Percent changes in the seizure frequency by subtype(52 weeks and until approval/launch)
- Clinical Global Impression of Change(52 weeks and until approval/launch)
研究者
研究点 (1)
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