Reply to "Chance Bias Arising from TSC2 Mutation Imbalance in the PREVeNT Trial".
Reply to "Chance Bias Arising from TSC2 Mutation Imbalance in the PREVeNT Trial".
复制标题
回复“预防试验中 TSC2 突变不平衡引起的机会偏差”。
DOI：
10.1002/ana.26857
复制
发表时间：
2024
影响因子：
11.2
通讯作者：
Bebin,EMartina
中科院分区：
文献类型：
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作者：
Bebin,EMartina
本文件是对一封质疑PREVeNT试验设计及其结果的信件的回复。该试验是一项IIb期试验，根据癫痫发作时的年龄进行分层随机化。该试验将耐药性癫痫（DRE）定义为两种抗癫痫药物治疗后的复发性癫痫发作，并根据国际抗癫痫联盟（ILAE）分类捕获特定的癫痫发作类型。在试验期间癫痫发作的参与者被转换为开放标签的氨己烯酸，并监测他们的癫痫发作控制。该文件还提到正在进行的与癫痫和发育结果相关的各种因素的分析。作者报告没有利益冲突。神经病学年鉴的版权是Wiley-Blackwell的财产，未经版权保持器的明确书面许可，其内容不得复制或通过电子邮件发送到多个网站或发布到列表服务器。但是，用户可以打印，下载或电子邮件文章供个人使用。这篇摘要可以删节。不保证副本的准确性。用户应参考原始出版版本的材料的完整摘要。版权适用于所有摘要。
This document is a reply to a letter questioning the design of the PREVeNT trial and its results. The trial was a phase IIb trial that used stratified randomization based on age at seizure onset. The trial defined drug-resistant epilepsy (DRE) as recurrent seizures after two antiseizure medications and captured specific seizure types based on the International League Against Epilepsy (ILAE) classification. Participants who had seizures during the trial were transitioned to open label vigabatrin, and their seizure control was monitored. The document also mentions ongoing analysis of various factors related to epilepsy and developmental outcomes. The author reports no conflicts of interest.[Extracted from the article]Copyright of Annals of Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. Copyright applies to all Abstracts.