Richard K Bogan1, Neil Feldman2, Helene A Emsellem3, Russell Rosenberg4, Yuan Lu5, Gary Bream6, Moise Khayrallah6, D Alan Lankford7. 1. SleepMed, Columbia, SC, USA. Electronic address: RBogan@sleepmed.md. 2. Clinical Research Group of St. Petersburg, St. Petersburg, FL, USA. 3. The Center for Sleep and Wake Disorders, Chevy Chase, MD, USA. 4. NeuroTrials Research, Atlanta, GA, USA. 5. Jazz Pharmaceuticals, Palo Alto, CA, USA. 6. Aerial BioPharma, LLC, Morrisville, NC, USA. 7. Sleep Disorders Center of Georgia, Atlanta, GA, USA.
Abstract
BACKGROUND:JZP-110 is a wake-promoting agent with dopaminergic and noradrenergic activity. METHODS: This double-blind, crossover study, randomized adults with narcolepsy with or without cataplexy (N = 33) to placebo or JZP-110 at 150 mg/day (weeks 1 and 3) increased to 300 mg/day (weeks 2 and 4). Patients had to have baselineEpworth Sleepiness Scale (ESS) scores ≥10 and mean sleep latencies ≤10 min on the Maintenance of Wakefulness Test (MWT). Efficacy end points included MWT sleep latency and ESS, and the percentage of patients improved on the Clinical Global Impression of Change. RESULTS:Patients were primarily male (57.6%) and white (69.7%), with a mean (standard deviation) age of 37.1 (12.4) years. At two weeks, the change in the mean MWT sleep latency was 11.8 min longer with JZP-110 than with placebo (P = 0.0002); JZP-110 resulted in greater changes in sleep latency on each MWT trial (P <0.001). For ESS, JZP-110 was more efficacious relative to placebo after 1 (P <0.0001) and two weeks (P = 0.0002); final ESS scores were 10.8 with JZP-110 and 15.2 with placebo, changes of -6.7 and -2.4, respectively. JZP-110 was generally well tolerated; the most common adverse events with JZP-110 were nausea (12%), noncardiac chest discomfort (9.1%), and headache (9.1%). CONCLUSIONS: The efficacy of JZP-110 for impaired wakefulness and excessive sleepiness was observed at 150-300 mg/day and as early as one week after initiating treatment (Clinicaltrials.gov identifier NCT01485770).
RCT Entities:
BACKGROUND:JZP-110 is a wake-promoting agent with dopaminergic and noradrenergic activity. METHODS: This double-blind, crossover study, randomized adults with narcolepsy with or without cataplexy (N = 33) to placebo or JZP-110 at 150 mg/day (weeks 1 and 3) increased to 300 mg/day (weeks 2 and 4). Patients had to have baseline Epworth Sleepiness Scale (ESS) scores ≥10 and mean sleep latencies ≤10 min on the Maintenance of Wakefulness Test (MWT). Efficacy end points included MWT sleep latency and ESS, and the percentage of patients improved on the Clinical Global Impression of Change. RESULTS:Patients were primarily male (57.6%) and white (69.7%), with a mean (standard deviation) age of 37.1 (12.4) years. At two weeks, the change in the mean MWT sleep latency was 11.8 min longer with JZP-110 than with placebo (P = 0.0002); JZP-110 resulted in greater changes in sleep latency on each MWT trial (P <0.001). For ESS, JZP-110 was more efficacious relative to placebo after 1 (P <0.0001) and two weeks (P = 0.0002); final ESS scores were 10.8 with JZP-110 and 15.2 with placebo, changes of -6.7 and -2.4, respectively. JZP-110 was generally well tolerated; the most common adverse events with JZP-110 were nausea (12%), noncardiac chest discomfort (9.1%), and headache (9.1%). CONCLUSIONS: The efficacy of JZP-110 for impaired wakefulness and excessive sleepiness was observed at 150-300 mg/day and as early as one week after initiating treatment (Clinicaltrials.gov identifier NCT01485770).
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