Ruoff Chad, Bogan Richard K, Emsellem Helen, Feldman Neil, Lankford Alan, Bream Gary, Khayrallah Moise, Lu Yuan, Carter Lawrence P, Black Jed
Stanford Sleep Medicine Center, Redwood City, CA, USA.
SleepMed of South Carolina, Columbia, SC, USA.
Sleep Med. 2017 Jul;35:12-16. doi: 10.1016/j.sleep.2017.03.025. Epub 2017 Apr 22.
To evaluate the effects of JZP-110 on the Maintenance of Wakefulness Test (MWT) with data censored to include only the first 20 min of a 40-min MWT.
In a 4-week, placebo-controlled crossover design (Study 201; N = 33) and a 12-week parallel-group design (Study 202; N = 93), JZP-110 was evaluated in narcolepsy patients using changes from baseline in the 40-min MWT as the primary endpoint. Effect sizes based on the change from baseline in mean MWT sleep latency were calculated using 20-min censored MWT data and compared to 40-min MWT data.
In Study 201, mean (standard deviation) changes in MWT sleep latency were 12.7 (10.6) min with JZP-110 versus 0.9 (6.0) min with placebo (P = 0.0002) for 40-min data, and 8.9 (6.3) versus 0.4 (4.6) min for 20-min censored data (P < 0.0001). In Study 202, mean changes in MWT sleep latency were 12.8 (10.3) min with JZP-110 versus 2.1 (7.9) min with placebo (P < 0.0001) for 40-min data, and 8.9 (5.5) versus 1.1 (5.6) min for 20-min censored data (P < 0.0001). In Studies 201 and 202, respectively, Cohen's d effect sizes were large and numerically greater for 20-min censored data (1.54 and 1.41) versus 40-min data (1.37 and 1.17).
In patients with narcolepsy, JZP-110 significantly improved the ability to stay awake compared with placebo, with large effect sizes using both the 40-min and 20-min censored MWT data.
在对数据进行截尾处理，仅纳入40分钟维持觉醒测试（MWT）的前20分钟数据的情况下，评估JZP - 110对维持觉醒测试的影响。
在一项为期4周的安慰剂对照交叉设计（研究201；N = 33）和一项为期12周的平行组设计（研究202；N = 93）中，以发作性睡病患者40分钟MWT相对于基线的变化作为主要终点，对JZP - 110进行评估。使用20分钟截尾的MWT数据计算基于平均MWT睡眠潜伏期相对于基线变化的效应量，并与40分钟MWT数据进行比较。
在研究201中，对于40分钟数据，JZP - 110组MWT睡眠潜伏期的平均（标准差）变化为12.7（10.6）分钟，安慰剂组为0.9（6.0）分钟（P = 0.0002）；对于20分钟截尾数据，分别为8.9（6.3）分钟和0.4（4.6）分钟（P < 0.0001）。在研究202中，对于40分钟数据，JZP - 110组MWT睡眠潜伏期的平均变化为12.8（10.3）分钟，安慰剂组为2.1（7.9）分钟（P < 0.0001）；对于20分钟截尾数据，分别为8.9（5.5）分钟和1.1（5.6）分钟（P < 0.0001）。在研究201和研究202中，20分钟截尾数据的科恩d效应量分别为1.54和1.41，均为大效应量且在数值上大于40分钟数据的效应量（1.37和1.）。
在发作性睡病患者中，与安慰剂相比，JZP - 110显著提高了保持清醒的能力，使用40分钟和20分钟截尾的MWT数据均显示出大效应量。
