Trial Outcomes & Findings for "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA" (NCT NCT02348606)
NCT ID: NCT02348606
Last Updated: 2019-07-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
476 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2019-07-23
Participant Flow
Note: 476 subjects were enrolled and randomized, however 2 subjects never received drug. This resulted in 474 subjects comprising the safety population.
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.
Participant milestones
| Measure |
37.5 mg of JZP-110
37.5 mg JZP-110 administered orally, once daily (QD), for the 12-week treatment phase.
|
75 mg of JZP-110
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
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.
|
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.
|
Placebo
Placebo administered orally, QD, for the 12 week treatment phase.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
62
|
117
|
118
|
119
|
|
Overall Study
COMPLETED
|
49
|
54
|
106
|
94
|
101
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
11
|
24
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Baseline characteristics by cohort
| Measure |
37.5 mg of JZP-110
n=58 Participants
37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
75 mg of JZP-110
n=62 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg of JZP-110
n=117 Participants
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.
|
300 mg of JZP-110
n=118 Participants
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.
|
Placebo
n=119 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
Total
n=474 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 10.19 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 11.46 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 10.57 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 10.62 • n=4 Participants
|
54.1 years
STANDARD_DEVIATION 11.41 • n=21 Participants
|
53.9 years
STANDARD_DEVIATION 10.75 • n=8 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
177 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
297 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
89 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
361 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Fifteen subjects in the Safety Population were excluded from the Modified Intent-to Treat (mITT) Population resulting in a total of 459 subjects.
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.
Outcome measures
| Measure |
37.5 mg of JZP-110
n=56 Participants
37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
75 mg of JZP-110
n=58 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg of JZP-110
n=116 Participants
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.
|
300 mg of JZP-110
n=115 Participants
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.
|
Placebo
n=114 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
|---|---|---|---|---|---|
|
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
|
4.74 minutes
Standard Error 1.418
|
9.08 minutes
Standard Error 1.358
|
10.96 minutes
Standard Error 0.973
|
12.99 minutes
Standard Error 1.038
|
0.21 minutes
Standard Error 0.997
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.
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.
Outcome measures
| Measure |
37.5 mg of JZP-110
n=56 Participants
37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
75 mg of JZP-110
n=58 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg of JZP-110
n=116 Participants
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.
|
300 mg of JZP-110
n=115 Participants
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.
|
Placebo
n=114 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
|---|---|---|---|---|---|
|
Change in ESS Score From Baseline to Week 12
|
-5.1 points on a scale
Standard Error 0.64
|
-5.0 points on a scale
Standard Error 0.62
|
-7.7 points on a scale
Standard Error 0.44
|
-7.9 points on a scale
Standard Error 0.46
|
-3.3 points on a scale
Standard Error 0.45
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.
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.
Outcome measures
| Measure |
37.5 mg of JZP-110
n=56 Participants
37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
75 mg of JZP-110
n=58 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg of JZP-110
n=116 Participants
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.
|
300 mg of JZP-110
n=115 Participants
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.
|
Placebo
n=114 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
|---|---|---|---|---|---|
|
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
|
55.4 percentage of subjects
|
72.4 percentage of subjects
|
89.7 percentage of subjects
|
88.7 percentage of subjects
|
49.1 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at week 12.
Outcome measures
| Measure |
37.5 mg of JZP-110
n=56 Participants
37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
75 mg of JZP-110
n=58 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg of JZP-110
n=116 Participants
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.
|
300 mg of JZP-110
n=115 Participants
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.
|
Placebo
n=114 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
|---|---|---|---|---|---|
|
Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12
Trial 5
|
3.57 minutes
Standard Error 1.952
|
7.75 minutes
Standard Error 1.839
|
8.05 minutes
Standard Error 1.347
|
7.59 minutes
Standard Error 1.432
|
0.18 minutes
Standard Error 1.361
|
|
Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12
Trial 1
|
3.03 minutes
Standard Error 1.881
|
5.77 minutes
Standard Error 1.808
|
10.87 minutes
Standard Error 1.284
|
12.48 minutes
Standard Error 1.401
|
-0.40 minutes
Standard Error 1.327
|
|
Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12
Trial 2
|
6.93 minutes
Standard Error 1.928
|
9.47 minutes
Standard Error 1.849
|
11.91 minutes
Standard Error 1.332
|
14.94 minutes
Standard Error 1.425
|
-0.44 minutes
Standard Error 1.380
|
|
Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12
Trial 3
|
3.59 minutes
Standard Error 1.837
|
11.32 minutes
Standard Error 1.751
|
11.50 minutes
Standard Error 1.261
|
10.90 minutes
Standard Error 1.340
|
0.58 minutes
Standard Error 1.294
|
|
Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12
Trial 4
|
6.11 minutes
Standard Error 1.845
|
9.04 minutes
Standard Error 1.794
|
8.93 minutes
Standard Error 1.272
|
11.94 minutes
Standard Error 1.359
|
1.29 minutes
Standard Error 1.305
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.
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.
Outcome measures
| Measure |
37.5 mg of JZP-110
n=56 Participants
37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
75 mg of JZP-110
n=58 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg of JZP-110
n=116 Participants
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.
|
300 mg of JZP-110
n=115 Participants
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.
|
Placebo
n=114 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
|---|---|---|---|---|---|
|
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 1.360
|
7.20 minutes
Standard Error 1.307
|
11.69 minutes
Standard Error 0.932
|
13.77 minutes
Standard Error 0.976
|
1.24 minutes
Standard Error 0.942
|
SECONDARY outcome
Timeframe: Baseline to Weeks 1, 4, and 8Change 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.
Outcome measures
| Measure |
37.5 mg of JZP-110
n=56 Participants
37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
75 mg of JZP-110
n=58 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg of JZP-110
n=116 Participants
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.
|
300 mg of JZP-110
n=115 Participants
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.
|
Placebo
n=114 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
|---|---|---|---|---|---|
|
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
|
-4.8 points on a scale
Standard Error 0.63
|
-6.1 points on a scale
Standard Error 0.45
|
-6.6 points on a scale
Standard Error 0.46
|
-2.9 points on a scale
Standard Error 0.45
|
|
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
|
-4.4 points on a scale
Standard Error 0.65
|
-5.5 points on a scale
Standard Error 0.46
|
-6.6 points on a scale
Standard Error 0.46
|
-2.6 points on a scale
Standard Error 0.47
|
|
Change in ESS Score From Baseline to Week 1, Week 4, and Week 8
Week 8
|
-4.7 points on a scale
Standard Error 0.70
|
-6.3 points on a scale
Standard Error 0.67
|
-6.9 points on a scale
Standard Error 0.48
|
-7.7 points on a scale
Standard Error 0.50
|
-3.8 points on a scale
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Weeks 1, 4, and 8Population: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.
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.
Outcome measures
| Measure |
37.5 mg of JZP-110
n=56 Participants
37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
75 mg of JZP-110
n=58 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg of JZP-110
n=116 Participants
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.
|
300 mg of JZP-110
n=115 Participants
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.
|
Placebo
n=114 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
|---|---|---|---|---|---|
|
Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8
Week 1
|
58.9 percentage of subjects
|
65.5 percentage of subjects
|
78.3 percentage of subjects
|
82.5 percentage of subjects
|
47.4 percentage of subjects
|
|
Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8
Week 4
|
60.7 percentage of subjects
|
77.6 percentage of subjects
|
84.5 percentage of subjects
|
84.3 percentage of subjects
|
53.5 percentage of subjects
|
|
Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8
Week 8
|
57.1 percentage of subjects
|
79.3 percentage of subjects
|
88.8 percentage of subjects
|
87.8 percentage of subjects
|
57.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 12Population: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.
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.
Outcome measures
| Measure |
37.5 mg of JZP-110
n=56 Participants
37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
75 mg of JZP-110
n=58 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg of JZP-110
n=116 Participants
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.
|
300 mg of JZP-110
n=115 Participants
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.
|
Placebo
n=114 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
|---|---|---|---|---|---|
|
Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12
|
58.9 percentage of subjects
|
70.7 percentage of subjects
|
90.5 percentage of subjects
|
88.7 percentage of subjects
|
49.1 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 1, 4, and 8Population: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.
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.
Outcome measures
| Measure |
37.5 mg of JZP-110
n=56 Participants
37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
75 mg of JZP-110
n=58 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg of JZP-110
n=116 Participants
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.
|
300 mg of JZP-110
n=115 Participants
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.
|
Placebo
n=114 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
|---|---|---|---|---|---|
|
Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8
Week 1
|
62.5 percentage of subjects
|
60.3 percentage of subjects
|
75.7 percentage of subjects
|
82.6 percentage of subjects
|
46.5 percentage of subjects
|
|
Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8
Week 4
|
60.7 percentage of subjects
|
77.6 percentage of subjects
|
85.2 percentage of subjects
|
81.7 percentage of subjects
|
52.6 percentage of subjects
|
|
Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8
Week 8
|
55.4 percentage of subjects
|
74.1 percentage of subjects
|
87.8 percentage of subjects
|
87.8 percentage of subjects
|
49.1 percentage of subjects
|
Adverse Events
37.5 mg of JZP-110
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
75 mg of JZP-110
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
150 mg of JZP-110
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
300 mg of JZP-110
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
37.5 mg of JZP-110
n=58 participants at risk
37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
75 mg of JZP-110
n=62 participants at risk
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg of JZP-110
n=117 participants at risk
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.
|
300 mg of JZP-110
n=118 participants at risk
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.
|
Placebo
n=119 participants at risk；n=110 participants at risk
Placebo administered orally, QD, for the 12 week treatment phase.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/58 • Through Week 14
|
0.00%
0/62 • Through Week 14
|
0.00%
0/117 • Through Week 14
|
0.00%
0/118 • Through Week 14
|
0.91%
1/110 • Through Week 14
|
|
Nervous system disorders
Sciatica
|
0.00%
0/58 • Through Week 14
|
0.00%
0/62 • Through Week 14
|
0.00%
0/117 • Through Week 14
|
0.00%
0/118 • Through Week 14
|
0.91%
1/110 • Through Week 14
|
|
Hepatobiliary disorders
Bile duct obstruction
|
1.7%
1/58 • Through Week 14
|
0.00%
0/62 • Through Week 14
|
0.00%
0/117 • Through Week 14
|
0.00%
0/118 • Through Week 14
|
0.00%
0/110 • Through Week 14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/58 • Through Week 14
|
0.00%
0/62 • Through Week 14
|
0.00%
0/117 • Through Week 14
|
0.00%
0/118 • Through Week 14
|
0.91%
1/110 • Through Week 14
|
|
Endocrine disorders
Goitre
|
0.00%
0/58 • Through Week 14
|
0.00%
0/62 • Through Week 14
|
0.00%
0/117 • Through Week 14
|
0.00%
0/118 • Through Week 14
|
0.91%
1/110 • Through Week 14
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/58 • Through Week 14
|
0.00%
0/62 • Through Week 14
|
0.85%
1/117 • Through Week 14
|
0.00%
0/118 • Through Week 14
|
0.00%
0/110 • Through Week 14
|
|
Infections and infestations
Streptococcal endocarditis
|
1.7%
1/58 • Through Week 14
|
0.00%
0/62 • Through Week 14
|
0.00%
0/117 • Through Week 14
|
0.00%
0/118 • Through Week 14
|
0.00%
0/110 • Through Week 14
|
Other adverse events
| Measure |
37.5 mg of JZP-110
n=58 participants at risk
37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
75 mg of JZP-110
n=62 participants at risk
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg of JZP-110
n=117 participants at risk
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.
|
300 mg of JZP-110
n=118 participants at risk
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.
|
Placebo
n=119 participants at risk；n=110 participants at risk
Placebo administered orally, QD, for the 12 week treatment phase.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
6.9%
4/58 • Through Week 14
|
8.1%
5/62 • Through Week 14
|
8.5%
10/117 • Through Week 14
|
14.4%
17/118 • Through Week 14
|
8.4%
10/119 • Through Week 14
|
|
General disorders
Feeling jittery
|
5.2%
3/58 • Through Week 14
|
4.8%
3/62 • Through Week 14
|
0.85%
1/117 • Through Week 14
|
5.9%
7/118 • Through Week 14
|
0.00%
0/119 • Through Week 14
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/58 • Through Week 14
|
3.2%
2/62 • Through Week 14
|
5.1%
6/117 • Through Week 14
|
13.6%
16/118 • Through Week 14
|
0.00%
0/119 • Through Week 14
|
|
Psychiatric disorders
Insomnia
|
1.7%
1/58 • Through Week 14
|
0.00%
0/62 • Through Week 14
|
2.6%
3/117 • Through Week 14
|
9.3%
11/118 • Through Week 14
|
1.7%
2/119 • Through Week 14
|
|
Psychiatric disorders
Irritability
|
5.2%
3/58 • Through Week 14
|
0.00%
0/62 • Through Week 14
|
3.4%
4/117 • Through Week 14
|
0.85%
1/118 • Through Week 14
|
0.00%
0/119 • Through Week 14
|
|
Gastrointestinal disorders
Nausea
|
5.2%
3/58 • Through Week 14
|
4.8%
3/62 • Through Week 14
|
8.5%
10/117 • Through Week 14
|
10.2%
12/118 • Through Week 14
|
5.9%
7/119 • Through Week 14
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/58 • Through Week 14
|
4.8%
3/62 • Through Week 14
|
4.3%
5/117 • Through Week 14
|
6.8%
8/118 • Through Week 14
|
0.84%
1/119 • Through Week 14
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
1/58 • Through Week 14
|
1.6%
1/62 • Through Week 14
|
4.3%
5/117 • Through Week 14
|
7.6%
9/118 • Through Week 14
|
1.7%
2/119 • Through Week 14
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.2%
3/58 • Through Week 14
|
0.00%
0/62 • Through Week 14
|
0.85%
1/117 • Through Week 14
|
0.00%
0/118 • Through Week 14
|
0.00%
0/119 • Through Week 14
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
1/58 • Through Week 14
|
4.8%
3/62 • Through Week 14
|
7.7%
9/117 • Through Week 14
|
11.9%
14/118 • Through Week 14
|
0.84%
1/119 • Through Week 14
|
|
Metabolism and nutrition disorders
Nasopharyngitis
|
3.4%
2/58 • Through Week 14
|
1.6%
1/62 • Through Week 14
|
6.0%
7/117 • Through Week 14
|
6.8%
8/118 • Through Week 14
|
6.7%
8/119 • Through Week 14
|
|
Metabolism and nutrition disorders
Sinusitis
|
1.7%
1/58 • Through Week 14
|
6.5%
4/62 • Through Week 14
|
0.00%
0/117 • Through Week 14
|
2.5%
3/118 • Through Week 14
|
2.5%
3/119 • Through Week 14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review trial results communications prior to public release and can embargo such communications for a period of at least 60 days from the time submitted to sponsor for review. If requested by sponsor, the PI will withhold publication for up to an additional 30 days. Furthermore, the first publication of study results must be a joint publication of all study sites unless a joint manuscript has not been submitted for publication within 12 months of completion of the study.
- Publication restrictions are in place
Restriction type: OTHER