This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
476
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12.
Time frame: Baseline to Week 12
Change in ESS Score From Baseline to Week 12
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
Time frame: Baseline to Week 12
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since start of treatment on a 7-point scale ranging from 1 = very much improved to 7 = very much worse. This is the key secondary endpoint.
Time frame: 12 Weeks
Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at week 12.
Time frame: Baseline and Week 12
Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to week 4.
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Pulmonary Associates
Glendale, Arizona, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Preferred Research Partners
Little Rock, Arkansas, United States
UC San Diego Medical Center
La Jolla, California, United States
So Cal Institute For Respiratory Diseases, Inc.
Los Angeles, California, United States
Pacific Sleep Medicine
Oceanside, California, United States
Stanford University Center for Narcolepsy
Redwood City, California, United States
Pacific Research Network, Inc.
San Diego, California, United States
PAB Clinical Research
Brandon, Florida, United States
MD Clinical
Hallandale, Florida, United States
...and 49 more locations
Time frame: Baseline to Week 4
Change in ESS Score From Baseline to Week 1, Week 4, and Week 8
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Weeks 1, 4, and 8. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
Time frame: Baseline to Weeks 1, 4, and 8
Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8
Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 1, Week 4, and Week 8. PGIc was rated by subjects and measures the change in their condition since treatment start on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.
Time frame: Weeks 1, 4, and 8
Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12
Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 12. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.
Time frame: Week 12
Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8
Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 1, Week 4, and Week 8. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.
Time frame: Weeks 1, 4, and 8