Trial Outcomes & Findings for "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy" (NCT NCT02348593)
NCT ID: NCT02348593
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. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
239 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2019-07-23
Participant Flow
239 subjects were randomized in a 1:1:1:1 ratio to receive placebo, 75 mg JZP-110, 150 mg JZP-110 or 300 mg JZP-110. 236 subjects received at least 1 dose of study medication and comprised the Safety Population; the remaining 3 subjects were randomized in error (did not receive study medication) and were excluded from the Safety Population.
Participant milestones
| Measure |
75 mg of JZP-110
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg 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 then 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
|
59
|
59
|
59
|
59
|
|
Overall Study
COMPLETED
|
49
|
51
|
43
|
52
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
16
|
7
|
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 Narcolepsy"
Baseline characteristics by cohort
| Measure |
75 mg of JZP-110
n=59 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg JZP-110
n=59 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
|
300 mg of JZP-110
n=59 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=59 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 12.78 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 13.00 • n=7 Participants
|
34.3 years
STANDARD_DEVIATION 11.51 • n=5 Participants
|
36.0 years
STANDARD_DEVIATION 15.17 • n=4 Participants
|
36.3 years
STANDARD_DEVIATION 12.47 • n=21 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
154 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
189 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 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
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 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. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing.
Outcome measures
| Measure |
Placebo
n=58 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
75 mg of JZP-110
n=59 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg JZP-110
n=55 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
|
300 mg of JZP-110
n=59 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.
|
|---|---|---|---|---|
|
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
|
2.12 minutes
Standard Error 1.289
|
4.74 minutes
Standard Error 1.335
|
9.77 minutes
Standard Error 1.327
|
12.27 minutes
Standard Error 1.389
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 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 |
Placebo
n=58 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
75 mg of JZP-110
n=59 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg JZP-110
n=55 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
|
300 mg of JZP-110
n=59 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.
|
|---|---|---|---|---|
|
Change in ESS Score From Baseline to Week 12
|
-1.6 points on a scale
Standard Error 0.65
|
-3.8 points on a scale
Standard Error 0.67
|
-5.4 points on a scale
Standard Error 0.66
|
-6.4 points on a scale
Standard Error 0.68
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 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 treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse
Outcome measures
| Measure |
Placebo
n=58 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
75 mg of JZP-110
n=59 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg JZP-110
n=55 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
|
300 mg of JZP-110
n=59 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.
|
|---|---|---|---|---|
|
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
|
39.7 percentage of subjects
|
67.8 percentage of subjects
|
78.2 percentage of subjects
|
84.7 percentage of subjects
|
SECONDARY outcome
Timeframe: Change from baseline for sleep latency in MWT during trial 1 at week 12Population: Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 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 |
Placebo
n=58 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
75 mg of JZP-110
n=59 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg JZP-110
n=55 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
|
300 mg of JZP-110
n=59 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.
|
|---|---|---|---|---|
|
Change in Sleep Latency Time on MWT Trial 1 at Week 12
|
-0.55 minutes
Standard Error 4.658
|
3.27 minutes
Standard Error 1.725
|
9.87 minutes
Standard Error 1.713
|
9.91 minutes
Standard Error 1.841
|
SECONDARY outcome
Timeframe: Change from baseline for sleep latency in MWT during trial 2 at week 12Population: Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 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 |
Placebo
n=58 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
75 mg of JZP-110
n=59 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg JZP-110
n=55 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
|
300 mg of JZP-110
n=59 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.
|
|---|---|---|---|---|
|
Change in Sleep Latency Time on MWT Trial 2 at Week 12
|
1.41 minutes
Standard Error 1.638
|
5.70 minutes
Standard Error 1.697
|
9.46 minutes
Standard Error 1.674
|
14.50 minutes
Standard Error 1.835
|
SECONDARY outcome
Timeframe: Change from baseline for sleep latency in MWT during trial 3 at week 12Population: Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 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 |
Placebo
n=58 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
75 mg of JZP-110
n=59 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg JZP-110
n=55 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
|
300 mg of JZP-110
n=59 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.
|
|---|---|---|---|---|
|
Change in Sleep Latency Time on MWT Trial 3 at Week 12
|
3.79 minutes
Standard Error 1.799
|
6.35 minutes
Standard Error 1.908
|
11.31 minutes
Standard Error 1.859
|
13.99 minutes
Standard Error 1.996
|
SECONDARY outcome
Timeframe: Change from baseline for sleep latency in MWT during trial 4 at week 12Population: Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 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 |
Placebo
n=58 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
75 mg of JZP-110
n=59 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg JZP-110
n=55 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
|
300 mg of JZP-110
n=59 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.
|
|---|---|---|---|---|
|
Change in Sleep Latency Time on MWT Trial 4 at Week 12
|
2.33 minutes
Standard Error 1.579
|
3.77 minutes
Standard Error 1.663
|
9.77 minutes
Standard Error 1.606
|
13.50 minutes
Standard Error 1.734
|
SECONDARY outcome
Timeframe: Change from baseline for sleep latency in MWT during trial 5 at week 12Population: Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 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 |
Placebo
n=58 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
75 mg of JZP-110
n=59 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg JZP-110
n=55 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
|
300 mg of JZP-110
n=59 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.
|
|---|---|---|---|---|
|
Change in Sleep Latency Time on MWT Trial 5 at Week 12
|
3.09 minutes
Standard Error 1.808
|
3.92 minutes
Standard Error 1.928
|
9.25 minutes
Standard Error 1.888
|
12.20 minutes
Standard Error 1.969
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 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 |
Placebo
n=58 Participants
Placebo administered orally, QD, for the 12 week treatment phase.
|
75 mg of JZP-110
n=59 Participants
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg JZP-110
n=55 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
|
300 mg of JZP-110
n=59 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.
|
|---|---|---|---|---|
|
Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-Minute MWT From Baseline to Week 4
|
2.16 minutes
Standard Error 1.202
|
4.67 minutes
Standard Error 1.223
|
9.15 minutes
Standard Error 1.246
|
13.07 minutes
Standard Error 1.211
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
75 mg of JZP-110
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
150 mg JZP-110
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
300 mg of JZP-110
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=59 participants at risk
Placebo administered orally, QD, for the 12 week treatment phase.
|
75 mg of JZP-110
n=59 participants at risk
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg JZP-110
n=59 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
|
300 mg of JZP-110
n=59 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.
|
|---|---|---|---|---|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/59 • Through Week 14
|
0.00%
0/59 • Through Week 14
|
1.7%
1/59 • Through Week 14
|
0.00%
0/59 • Through Week 14
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/59 • Through Week 14
|
0.00%
0/59 • Through Week 14
|
1.7%
1/59 • Through Week 14
|
0.00%
0/59 • Through Week 14
|
Other adverse events
| Measure |
Placebo
n=59 participants at risk
Placebo administered orally, QD, for the 12 week treatment phase.
|
75 mg of JZP-110
n=59 participants at risk
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
|
150 mg JZP-110
n=59 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
|
300 mg of JZP-110
n=59 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.
|
|---|---|---|---|---|
|
Investigations
Weight decreased
|
0.00%
0/59 • Through Week 14
|
1.7%
1/59 • Through Week 14
|
1.7%
1/59 • Through Week 14
|
5.1%
3/59 • Through Week 14
|
|
Investigations
Heart rate increased
|
0.00%
0/59 • Through Week 14
|
0.00%
0/59 • Through Week 14
|
0.00%
0/59 • Through Week 14
|
6.8%
4/59 • Through Week 14
|
|
Investigations
Weight increased
|
5.1%
3/59 • Through Week 14
|
3.4%
2/59 • Through Week 14
|
0.00%
0/59 • Through Week 14
|
1.7%
1/59 • Through Week 14
|
|
Nervous system disorders
Headache
|
5.1%
3/59 • Through Week 14
|
10.2%
6/59 • Through Week 14
|
23.7%
14/59 • Through Week 14
|
30.5%
18/59 • Through Week 14
|
|
Nervous system disorders
Dizziness
|
3.4%
2/59 • Through Week 14
|
3.4%
2/59 • Through Week 14
|
1.7%
1/59 • Through Week 14
|
5.1%
3/59 • Through Week 14
|
|
General disorders
Fatigue
|
0.00%
0/59 • Through Week 14
|
0.00%
0/59 • Through Week 14
|
3.4%
2/59 • Through Week 14
|
5.1%
3/59 • Through Week 14
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/59 • Through Week 14
|
1.7%
1/59 • Through Week 14
|
5.1%
3/59 • Through Week 14
|
8.5%
5/59 • Through Week 14
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/59 • Through Week 14
|
3.4%
2/59 • Through Week 14
|
0.00%
0/59 • Through Week 14
|
5.1%
3/59 • Through Week 14
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/59 • Through Week 14
|
5.1%
3/59 • Through Week 14
|
10.2%
6/59 • Through Week 14
|
10.2%
6/59 • Through Week 14
|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
2/59 • Through Week 14
|
5.1%
3/59 • Through Week 14
|
6.8%
4/59 • Through Week 14
|
10.2%
6/59 • Through Week 14
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/59 • Through Week 14
|
3.4%
2/59 • Through Week 14
|
5.1%
3/59 • Through Week 14
|
5.1%
3/59 • Through Week 14
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/59 • Through Week 14
|
1.7%
1/59 • Through Week 14
|
3.4%
2/59 • Through Week 14
|
5.1%
3/59 • Through Week 14
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/59 • Through Week 14
|
5.1%
3/59 • Through Week 14
|
1.7%
1/59 • Through Week 14
|
0.00%
0/59 • Through Week 14
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
1/59 • Through Week 14
|
8.5%
5/59 • Through Week 14
|
8.5%
5/59 • Through Week 14
|
15.3%
9/59 • Through Week 14
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
3/59 • Through Week 14
|
8.5%
5/59 • Through Week 14
|
13.6%
8/59 • Through Week 14
|
5.1%
3/59 • Through Week 14
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
1/59 • Through Week 14
|
1.7%
1/59 • Through Week 14
|
6.8%
4/59 • Through Week 14
|
0.00%
0/59 • Through Week 14
|
|
Infections and infestations
Influenza
|
5.1%
3/59 • Through Week 14
|
3.4%
2/59 • Through Week 14
|
1.7%
1/59 • Through Week 14
|
1.7%
1/59 • Through Week 14
|
Additional Information
Director, Disclosure & Transparency
Jazz Pharmaceuticals
Phone: 215-970-7145
Email: [email protected]
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