Evaluation of the Effect of JZP-110 in Patients with Narcolepsy Assessed Using the Maintenance of Wakefulness Test Censored to 20 Minutes

Abstract Objective To evaluate the effects of JZP-110 on the Maintenance of Wakefulness Test (MWT) with data censored to include only the first 20 minutes of a 40-minute MWT. Methods In a four-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-minute MWT as the primary endpoint. Effect sizes based on the change from baseline in mean MWT sleep latency were calculated using 20-minute censored MWT data and compared to 40-minute MWT data. Results In Study 201, mean (standard deviation) changes in MWT sleep latency were 12.7 (10.6) minutes with JZP-110 versus 0.9 (6.0) minutes with placebo ( P =0.0002) for 40-minute data, and 8.9 (6.3) versus 0.4 (4.6) minutes for 20-minute censored data ( P