[Translation] A study evaluating Staccato alprazolam in study participants 12 years of age and older with stereotyped epilepsy with prolonged seizures
A double-blind, randomized, placebo-controlled, multicenter, out-of-hospital, parallel-group study of the efficacy and safety of
比较 Staccato 阿普唑仑单次给药与安慰剂在 IMP 给药后90 秒内成功快速终止癫痫发作
比较 Staccato 阿普唑仑单次给药与安慰剂在 90 秒内快速成功终止癫痫发作,且 IMP给药后 2 小时内癫痫发作未复发
比较 Staccato 阿普唑仑单次给药与安慰剂在 90 秒内快速成功终止癫痫发作,且 IMP给药后 4 小时内癫痫发作未复发
比较 Staccato 阿普唑仑单次给药与安慰剂在 90 秒内快速成功终止癫痫发作,且 IMP给药后 6 小时内癫痫发作未复发
比较 Staccato 阿普唑仑组与安慰剂组之间从 IMP 给药至所治疗癫痫发作终止的时间
评价 Staccato 阿普唑仑单次给药相较于安慰剂的肺部安全性
比较 Staccato 阿普唑仑组与安慰剂组之间 IMP 给药后 2小时内的后续癫痫发作的发生率
[Translation] Comparison of Staccato Alprazolam Single Dose vs Placebo for Successful Rapid Seizure Termination within 90 Seconds of IMP Dosing
Comparison of Staccato alprazolam single-dose versus placebo for rapid and successful seizure termination within 90 seconds with no seizure recurrence within 2 hours of IMP administration
Comparison of Staccato alprazolam single-dose versus placebo for rapid and successful seizure termination within 90 seconds with no seizure recurrence within 4 hours of IMP administration
Comparison of Staccato alprazolam single-dose versus placebo for rapid and successful seizure termination within 90 seconds with no seizure recurrence within 6 hours of IMP administration
Comparison of time from IMP administration to termination of treated seizures between Staccato alprazolam and placebo groups
To evaluate the pulmonary safety of a single dose of Staccato alprazolam compared to placebo
To compare the incidence of subsequent seizures within 2 hours of IMP administration between the Staccato alprazolam group and the placebo group