[Translation] A double-blind, randomized, placebo-controlled, multicenter, out-of-hospital, parallel-group study evaluating the efficacy and safety of Staccato alprazolam in study participants 12 years of age and older with prolonged stereotyped seizures
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 the rapid and successful termination of seizures within 90 seconds after IMP administration between a single dose of Staccato alprazolam and placebo
Comparison of the rapid and successful termination of seizures within 90 seconds after IMP administration between a single dose of Staccato alprazolam and placebo, and no recurrence of seizures within 2 hours after IMP administration
Comparison of the rapid and successful termination of seizures within 90 seconds after IMP administration between a single dose of Staccato alprazolam and placebo, and no recurrence of seizures within 4 hours after IMP administration
Comparison of the rapid and successful termination of seizures within 90 seconds after IMP administration between a single dose of Staccato alprazolam and placebo, and no recurrence of seizures within 6 hours after IMP administration
Comparison of the time from IMP administration to termination of treated seizures between Staccato alprazolam and placebo
Evaluation of the pulmonary safety of a single dose of Staccato alprazolam compared to placebo
Comparison of the incidence of subsequent seizures within 2 hours after IMP administration between Staccato alprazolam and placebo