在临床试验参与者中,发作频率减少的模式,基线发作频率较低
Wesley T Kerr1,2, Advith S Reddy1, Neo Kok1
1Department of Neurology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Epilepsia
|March 14, 2026
概括
在试验中,基线发作频率与治疗反应之间的联系是不一致的. 在大多数试验中,这种关联没有影响统计力或活性治疗与安慰剂之间的差异.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 的研究研究.
背景情况:
- 的临床试验需要特定的发作频率标准来选择参与者.
- 了解基线发作频率与治疗反应之间的关系对于优化试验设计至关重要.
研究的目的:
- 为了评估基线发作频率和双盲期间发作减少之间的关联.
- 在临床试验中根据发作频率选择包括标准.
主要方法:
- 来自11个双盲,安慰剂控制的试验的数据分析.
- 评估基线发作频率与50%的响应率和百分比发作减少之间的关联.
- 在安慰剂和活性治疗组中基于显著关联 (p < .05) 的模式识别.
- 评估预先随机化的时间对每月发作数 (T-PSC) 设计的影响.
主要成果:
- 在55%的试验中,没有发现基线和维持发作频率之间的显著关联.
- 在19%的试验中,对于较低的基线频率,在安慰剂和活性治疗组中观察到平行增加的反应.
- 在19%的试验中,活性治疗在基线频率较低时显示出更大的发作减少,但在安慰剂组中并非如此.
- T-PSC的设计没有改变这些观察到的关联.
结论:
- 基线发作频率与发作减少的大小之间的关联在试验中不一致.
- 在大多数试验中,这种不一致性并没有影响统计力或活性治疗和安慰剂疗效之间的差异.
- 在一些试验中,活性疗法在基线发作频率较低的参与者中显示出潜在的更高的疗效.
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