Obstructive Sleep Apnea
Conditions
Brief summary
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.
Interventions
DRUGJZP-110
DRUGPlacebo oral tablet
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Major Inclusion Criteria: 1. Male or female between 18 and 75 years of age, inclusive 2. Diagnosis of OSA according to ICSD-3 criteria 3. Body mass index from 18 to \<45 kg/m2 4. Consent to use a medically acceptable method of contraception 5. Willing and able to provide written informed consent Major
Exclusion criteria
1. Female subjects who are pregnant, nursing, or lactating 2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness 3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria 4. History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator. 5. History of bariatric surgery within the past year or a history of any gastric bypass procedure 6. Presence or history of significant cardiovascular disease 7. Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness 8. Received an investigational drug in the past 30 days or five half-lives 9. Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A) 10. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 | 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. |
| Change in ESS Score From Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4 | 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. |
| Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Baseline to Weeks 1, 4, and 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. |
| Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12 | 12 Weeks | 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. |
| Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12 | 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. |
| Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Weeks 1, 4, and 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. |
| Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Weeks 1, 4, and 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. |
| Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Baseline and Week 12 | Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at week 12. |
Countries
Canada, France, Germany, Netherlands, United States
Participant flow
Recruitment details
Note: 476 subjects were enrolled and randomized, however 2 subjects never received drug. This resulted in 474 subjects comprising the safety population.
Pre-assignment details
During screening, subjects completed a medical exam. An overnight Polysomnography (PSG) assessment followed by MWT and 24-hour ABPM were conducted at baseline. After successful completion of the screening and baseline visits subjects were randomized in a 1:1:2:2:2 ratio to receive 37.5, 75, 150, or 300 mg JZP- 110 or placebo.
Participants by arm
| Arm | Count |
|---|---|
| 37.5 mg of JZP-110 37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase. | 58 |
| 75 mg of JZP-110 75 mg JZP-110 administered orally, QD, for the 12-week treatment phase. | 62 |
| 150 mg of JZP-110 Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD. | 117 |
| 300 mg of JZP-110 Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD. | 118 |
| Placebo Placebo administered orally, QD, for the 12 week treatment phase. | 119 |
| Total | 474 |
Baseline characteristics
| Characteristic | 37.5 mg of JZP-110 | Total | Placebo | 300 mg of JZP-110 | 150 mg of JZP-110 | 75 mg of JZP-110 |
|---|---|---|---|---|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 10.19 | 53.9 years STANDARD_DEVIATION 10.75 | 54.1 years STANDARD_DEVIATION 11.41 | 53.2 years STANDARD_DEVIATION 10.62 | 52.7 years STANDARD_DEVIATION 10.57 | 54.4 years STANDARD_DEVIATION 11.46 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 17 Participants | 4 Participants | 6 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 89 Participants | 26 Participants | 21 Participants | 18 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 4 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 45 Participants | 361 Participants | 87 Participants | 90 Participants | 93 Participants | 46 Participants |
| Sex: Female, Male Female | 19 Participants | 177 Participants | 42 Participants | 44 Participants | 45 Participants | 27 Participants |
| Sex: Female, Male Male | 39 Participants | 297 Participants | 77 Participants | 74 Participants | 72 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 62 | 0 / 117 | 0 / 118 | 0 / 119 |
| other Total, other adverse events | 17 / 58 | 21 / 62 | 41 / 117 | 60 / 118 | 30 / 119 |
| serious Total, serious adverse events | 2 / 58 | 0 / 62 | 1 / 117 | 0 / 118 | 2 / 110 |
Outcome results
Primary
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
Population: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 37.5 mg of JZP-110 | Change in ESS Score From Baseline to Week 12 | -5.1 points on a scale | Standard Error 0.64 |
| 75 mg of JZP-110 | Change in ESS Score From Baseline to Week 12 | -5.0 points on a scale | Standard Error 0.62 |
| 150 mg of JZP-110 | Change in ESS Score From Baseline to Week 12 | -7.7 points on a scale | Standard Error 0.44 |
| 300 mg of JZP-110 | Change in ESS Score From Baseline to Week 12 | -7.9 points on a scale | Standard Error 0.46 |
| Placebo | Change in ESS Score From Baseline to Week 12 | -3.3 points on a scale | Standard Error 0.45 |
Primary
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
Population: Fifteen subjects in the Safety Population were excluded from the Modified Intent-to Treat (mITT) Population resulting in a total of 459 subjects.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 37.5 mg of JZP-110 | Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 | 4.74 minutes | Standard Error 1.418 |
| 75 mg of JZP-110 | Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 | 9.08 minutes | Standard Error 1.358 |
| 150 mg of JZP-110 | Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 | 10.96 minutes | Standard Error 0.973 |
| 300 mg of JZP-110 | Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 | 12.99 minutes | Standard Error 1.038 |
| Placebo | Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 | 0.21 minutes | Standard Error 0.997 |
Secondary
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 37.5 mg of JZP-110 | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 8 | -4.7 points on a scale | Standard Error 0.7 |
| 37.5 mg of JZP-110 | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 4 | -4.7 points on a scale | Standard Error 0.65 |
| 37.5 mg of JZP-110 | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 1 | -4.5 points on a scale | Standard Error 0.66 |
| 75 mg of JZP-110 | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 8 | -6.3 points on a scale | Standard Error 0.67 |
| 75 mg of JZP-110 | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 1 | -4.4 points on a scale | Standard Error 0.65 |
| 75 mg of JZP-110 | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 4 | -4.8 points on a scale | Standard Error 0.63 |
| 150 mg of JZP-110 | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 8 | -6.9 points on a scale | Standard Error 0.48 |
| 150 mg of JZP-110 | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 1 | -5.5 points on a scale | Standard Error 0.46 |
| 150 mg of JZP-110 | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 4 | -6.1 points on a scale | Standard Error 0.45 |
| 300 mg of JZP-110 | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 1 | -6.6 points on a scale | Standard Error 0.46 |
| 300 mg of JZP-110 | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 4 | -6.6 points on a scale | Standard Error 0.46 |
| 300 mg of JZP-110 | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 8 | -7.7 points on a scale | Standard Error 0.5 |
| Placebo | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 1 | -2.6 points on a scale | Standard Error 0.47 |
| Placebo | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 4 | -2.9 points on a scale | Standard Error 0.45 |
| Placebo | Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 | Week 8 | -3.8 points on a scale | Standard Error 0.49 |
Secondary
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
Population: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 37.5 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 4 | 6.11 minutes | Standard Error 1.845 |
| 37.5 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 2 | 6.93 minutes | Standard Error 1.928 |
| 37.5 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 3 | 3.59 minutes | Standard Error 1.837 |
| 37.5 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 5 | 3.57 minutes | Standard Error 1.952 |
| 37.5 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 1 | 3.03 minutes | Standard Error 1.881 |
| 75 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 1 | 5.77 minutes | Standard Error 1.808 |
| 75 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 5 | 7.75 minutes | Standard Error 1.839 |
| 75 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 4 | 9.04 minutes | Standard Error 1.794 |
| 75 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 2 | 9.47 minutes | Standard Error 1.849 |
| 75 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 3 | 11.32 minutes | Standard Error 1.751 |
| 150 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 2 | 11.91 minutes | Standard Error 1.332 |
| 150 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 3 | 11.50 minutes | Standard Error 1.261 |
| 150 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 1 | 10.87 minutes | Standard Error 1.284 |
| 150 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 4 | 8.93 minutes | Standard Error 1.272 |
| 150 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 5 | 8.05 minutes | Standard Error 1.347 |
| 300 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 2 | 14.94 minutes | Standard Error 1.425 |
| 300 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 1 | 12.48 minutes | Standard Error 1.401 |
| 300 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 4 | 11.94 minutes | Standard Error 1.359 |
| 300 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 3 | 10.90 minutes | Standard Error 1.34 |
| 300 mg of JZP-110 | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 5 | 7.59 minutes | Standard Error 1.432 |
| Placebo | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 5 | 0.18 minutes | Standard Error 1.361 |
| Placebo | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 3 | 0.58 minutes | Standard Error 1.294 |
| Placebo | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 2 | -0.44 minutes | Standard Error 1.38 |
| Placebo | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 4 | 1.29 minutes | Standard Error 1.305 |
| Placebo | Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 | Trial 1 | -0.40 minutes | Standard Error 1.327 |
Secondary
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.
Time frame: Baseline to Week 4
Population: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 37.5 mg of JZP-110 | Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4 | 4.53 minutes | Standard Error 1.36 |
| 75 mg of JZP-110 | Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4 | 7.20 minutes | Standard Error 1.307 |
| 150 mg of JZP-110 | Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4 | 11.69 minutes | Standard Error 0.932 |
| 300 mg of JZP-110 | Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4 | 13.77 minutes | Standard Error 0.976 |
| Placebo | Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4 | 1.24 minutes | Standard Error 0.942 |
Secondary
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
Population: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 37.5 mg of JZP-110 | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 1 | 62.5 percentage of subjects |
| 37.5 mg of JZP-110 | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 8 | 55.4 percentage of subjects |
| 37.5 mg of JZP-110 | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 4 | 60.7 percentage of subjects |
| 75 mg of JZP-110 | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 4 | 77.6 percentage of subjects |
| 75 mg of JZP-110 | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 1 | 60.3 percentage of subjects |
| 75 mg of JZP-110 | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 8 | 74.1 percentage of subjects |
| 150 mg of JZP-110 | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 4 | 85.2 percentage of subjects |
| 150 mg of JZP-110 | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 1 | 75.7 percentage of subjects |
| 150 mg of JZP-110 | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 8 | 87.8 percentage of subjects |
| 300 mg of JZP-110 | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 1 | 82.6 percentage of subjects |
| 300 mg of JZP-110 | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 8 | 87.8 percentage of subjects |
| 300 mg of JZP-110 | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 4 | 81.7 percentage of subjects |
| Placebo | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 4 | 52.6 percentage of subjects |
| Placebo | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 1 | 46.5 percentage of subjects |
| Placebo | Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 | Week 8 | 49.1 percentage of subjects |
Secondary
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
Population: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 37.5 mg of JZP-110 | Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12 | 58.9 percentage of subjects |
| 75 mg of JZP-110 | Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12 | 70.7 percentage of subjects |
| 150 mg of JZP-110 | Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12 | 90.5 percentage of subjects |
| 300 mg of JZP-110 | Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12 | 88.7 percentage of subjects |
| Placebo | Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12 | 49.1 percentage of subjects |
Secondary
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
Population: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 37.5 mg of JZP-110 | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 1 | 58.9 percentage of subjects |
| 37.5 mg of JZP-110 | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 4 | 60.7 percentage of subjects |
| 37.5 mg of JZP-110 | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 8 | 57.1 percentage of subjects |
| 75 mg of JZP-110 | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 4 | 77.6 percentage of subjects |
| 75 mg of JZP-110 | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 1 | 65.5 percentage of subjects |
| 75 mg of JZP-110 | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 8 | 79.3 percentage of subjects |
| 150 mg of JZP-110 | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 1 | 78.3 percentage of subjects |
| 150 mg of JZP-110 | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 4 | 84.5 percentage of subjects |
| 150 mg of JZP-110 | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 8 | 88.8 percentage of subjects |
| 300 mg of JZP-110 | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 1 | 82.5 percentage of subjects |
| 300 mg of JZP-110 | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 4 | 84.3 percentage of subjects |
| 300 mg of JZP-110 | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 8 | 87.8 percentage of subjects |
| Placebo | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 4 | 53.5 percentage of subjects |
| Placebo | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 8 | 57.0 percentage of subjects |
| Placebo | Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 | Week 1 | 47.4 percentage of subjects |
Secondary
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
Population: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 37.5 mg of JZP-110 | Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12 | 55.4 percentage of subjects |
| 75 mg of JZP-110 | Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12 | 72.4 percentage of subjects |
| 150 mg of JZP-110 | Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12 | 89.7 percentage of subjects |
| 300 mg of JZP-110 | Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12 | 88.7 percentage of subjects |
| Placebo | Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12 | 49.1 percentage of subjects |