Clinical Evaluation of BW430C in Epilepsy<Phase III Study>
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Number of Participants With Any Rash Event (Including Stevens-Johnson Syndrome [SJS] and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment
研究概览
简要总结
To evaluate safety information of BW430C when administered using the lower starting doses and slower dose escalations as recommended Global Data Sheet
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
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
lamictal
干预措施: lamictal (Drug)
结局指标
主要结局
Number of Participants With Any Rash Event (Including Stevens-Johnson Syndrome [SJS] and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment
时间窗: 8 weeks
Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing "rash"; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the "Skin and Subcutaneous Tissue Disorders" system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection.
次要结局
- Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment(8 weeks)
- Number of Participants With Any Rash Event (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase(Up to Week 8 of the Maintenance Phase (Study Week 14))
- Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment(8 weeks)
- Number of Rash Events (Including SJS and Any Other Serious Drug Eruption) Adjudicated by the Rash Adjudication Committee in Participants Taking VPA(Up to Week 8 of the Maintenance Phase (Study Week 14))
- Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment(8 weeks)
- Percent Change in Seizure Frequency of the Indicated Types of Seizures(Pre-treatment (Day 0) and Week 8 of the Maintenance Phase (Study Week 14))
- Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase(Up to Week 8 of the Maintenance Phase (Study Week 14))
- Percentage of Participants With Monocyte Values Outside the Normal Range (Shifted High) at Weeks 4 and 8(Week 4 and Week 8)
- Percentage of Participants With at Least a 50 Percent Reduction in Seizure Frequency for the Indicated Types of Seizures(8 weeks)
- Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase(Up to Week 8 of the Maintenance Phase (Study Week 14))
- Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase(Up to Week 8 of the Maintenance Phase (Study Week 14))