Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5643602 | Sleep Medicine | 2017 | 5 Pages |
â¢JZP-110 has wake-promoting effects.â¢JZP-110 improved the ability of narcolepsy patients to stay awake versus placebo.â¢Robust Maintenance of Wakefulness Test improvements were maintained throughout the day.â¢Maintenance of Wakefulness Test improvements were independent of 40- or 20-min data.â¢Effect sizes on the Maintenance of Wakefulness Test for JZP-110 were consistently large.
ObjectiveTo evaluate the effects of JZP-110 on the Maintenance of Wakefulness Test (MWT) with data censored to include only the first 20Â min of a 40-min MWT.MethodsIn a 4-week, placebo-controlled crossover design (Study 201; NÂ =Â 33) and a 12-week parallel-group design (Study 202; NÂ =Â 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.ResultsIn 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 (PÂ =Â 0.0002) for 40-min data, and 8.9 (6.3) versus 0.4 (4.6) min for 20-min censored data (PÂ <Â 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 (PÂ <Â 0.0001) for 40-min data, and 8.9 (5.5) versus 1.1 (5.6) min for 20-min censored data (PÂ <Â 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).ConclusionsIn 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.