This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter 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
174
Change in the Maintenance of Wakefulness Test (MWT)
Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. Mean sleep latency defined as the average of the first four MWT trial's measurements.
Time frame: Week 4 to Week 6
Change in the Epworth Sleepiness Scale (ESS)
Change in Epworth Sleepiness Scale (ESS) score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. 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 week 4 to week 6.
Time frame: Week 4 to Week 6
Patient Global Impression of Change (PGIc)
Percentage of subjects reported as worse (minimally, much, or very much) on the PGIc at the end of the Double-blind Withdrawal Phase. PGIc was rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.
Time frame: Week 4 to Week 6
Clinical Global Impression of Change (CGIc)
Percentage of subjects reported as worse (minimally, much, or very much) on the CGIc at the end of the Double-blind Withdrawal Phase. 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 4 to Week 6
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Sleep Disorder Center of Alabama
Birmingham, Alabama, United States
The Research Center of Southern California
Oceanside, California, United States
SDS Clinical Trials, INC
Orange, California, United States
Santa Monica Clinical Trials
Santa Monica, California, United States
Critical Care Pulmonary & Sleep Associates, LLC
Lakewood, Colorado, United States
PAB Clinical Research
Brandon, Florida, United States
Broward Research Group, Inc.
Hollywood, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
Emory Sleep Center
Atlanta, Georgia, United States
Rowe Neurology Institute RNI - Lenexa
Lenexa, Kansas, United States
...and 20 more locations
Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Change is total score from the end of the stable dose phase to the end of the double blind withdrawal phase. Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10) is a 10-item disease-specific quality of life questionnaire to assess the effect of excessiveness sleepiness on multiple activities of everyday living. The FOSQ-10 consists of 10 questions, each scored on a scale from 1-4. The questionnaire has a 4-point response format for each question (1 = extreme difficulty, 2 = moderate difficulty, 3 = a little difficulty, and 4 = no difficulty). The total score is derived by the mean of the 5 subscale scores, multiplied by 5, resulting in a possible range of scores between 5 to 20; lower FOSQ-10 scores are worse, indicating more difficulty carrying out activities; higher FOSQ-10 scores are better, indicating less difficulty carrying out activities.
Time frame: Week 4 to Week 6