Trial Outcomes & Findings for A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy (NCT NCT02221869)
NCT ID: NCT02221869
Last Updated: 2019-04-30
Results Overview
Double-blind comparison of the change in weekly number of cataplexy attacks from the last 2 weeks of the Stable Dose Period to the 2 weeks of the Double-blind Treatment Period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
106 participants
Primary outcome timeframe
From the end of the Stable Dose Period to the end of the Double-blind Treatment Period (2 weeks)
Results posted on
2019-04-30
Participant Flow
106 subjects were enrolled. Xyrem-naïve subjects (n=74) entered the Dose Titration Period (3 to 10 weeks). Xyrem-naïve and on Xyrem subjects (n= 99) entered the Stable Dose Period (2 to 3 weeks). 96 subjects then entered the Double-Blind Randomized Withdrawal Period (2 weeks). 95 subjects then entered the Open-label Safety Period (38 to 47 weeks).
Subjects aged 7-17 who were being treated with Xyrem or Xyrem naïve were eligible for the study. 63 subjects were randomized and 33 received open-label Xyrem during the Double-blind Treatment Period. 106 and 63 subjects comprised the Enrolled population and the Efficacy population respectively.
Participant milestones
| Measure |
Randomized to Xyrem
Active Xyrem continued as a double-blind treatment at the stable dose taken and regimen taken in the prior 2 weeks.
|
Randomized to Xyrem Placebo
Xyrem placebo was initiated as a double-blind treatment at a volume and regimen equivalent to the Xyrem dose taken in the prior 2 weeks.
|
Open-label Xyrem
Subjects who were not randomized or continued to receive open-label Xyrem during the Double-blind Treatment Period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
43
|
|
Overall Study
COMPLETED
|
30
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
Baseline characteristics by cohort
| Measure |
Enrolled Population
n=106 Participants
The Enrolled Population consists of all subjects who were dispensed study drug.
|
Placebo (Efficacy Population)
n=32 Participants
Xyrem placebo was initiated as a double-blind treatment at a volume and regimen equivalent to the Xyrem dose taken in the prior 2 weeks in the 2-week double-blind treatment period.
|
Xyrem (Efficacy Population)
n=31 Participants
Active Xyrem continued as a double-blind treatment at the stable dose taken and regimen taken in the prior 2 weeks in the 2-week double-blind treatment period.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
Enrolled Population · <=18 years
|
106 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
—
|
—
|
106 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Age, Categorical
Enrolled Population · Between 18 and 65 years
|
0 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
—
|
—
|
0 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Age, Categorical
Enrolled Population · >=65 years
|
0 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
—
|
—
|
0 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Age, Categorical
Efficacy Population · <=18 years
|
—
|
32 Participants
n=32 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
31 Participants
n=31 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
63 Participants
n=63 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Age, Categorical
Efficacy Population · Between 18 and 65 years
|
—
|
0 Participants
n=32 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
0 Participants
n=31 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
0 Participants
n=63 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Age, Categorical
Efficacy Population · >=65 years
|
—
|
0 Participants
n=32 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
0 Participants
n=31 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
0 Participants
n=63 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Sex: Female, Male
Enrolled Population · Female
|
43 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
0 Participants
Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
—
|
43 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Sex: Female, Male
Enrolled Population · Male
|
63 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
0 Participants
Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
—
|
63 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Sex: Female, Male
Efficacy Population · Female
|
—
|
15 Participants
n=32 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
13 Participants
n=31 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
28 Participants
n=63 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Sex: Female, Male
Efficacy Population · Male
|
—
|
17 Participants
n=32 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
18 Participants
n=31 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
35 Participants
n=63 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Ethnicity (NIH/OMB)
Enrolled Population · Hispanic or Latino
|
6 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
—
|
—
|
6 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Ethnicity (NIH/OMB)
Enrolled Population · Not Hispanic or Latino
|
100 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
—
|
—
|
100 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Ethnicity (NIH/OMB)
Enrolled Population · Unknown or Not Reported
|
0 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
—
|
—
|
0 Participants
n=106 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Ethnicity (NIH/OMB)
Efficacy Population · Hispanic or Latino
|
—
|
2 Participants
n=32 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
0 Participants
n=31 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
2 Participants
n=63 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Ethnicity (NIH/OMB)
Efficacy Population · Not Hispanic or Latino
|
—
|
30 Participants
n=32 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
31 Participants
n=31 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
61 Participants
n=63 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Ethnicity (NIH/OMB)
Efficacy Population · Unknown or Not Reported
|
—
|
0 Participants
n=32 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
0 Participants
n=31 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
0 Participants
n=63 Participants • Measure Analysis Population Description: Data analyzed separately for Enrolled and Efficacy populations
|
|
Region of Enrollment
Netherlands
|
8 Participants
n=106 Participants • Measure Analysis Population Description: Data reported for the Enrolled Population
|
3 participants
n=32 Participants • Measure Analysis Population Description: Data reported for Efficacy Population
|
2 participants
n=31 Participants • Measure Analysis Population Description: Data reported for Efficacy Population
|
5 participants
n=63 Participants • Measure Analysis Population Description: Data reported for Efficacy Population
|
|
Region of Enrollment
United States
|
62 Participants
n=106 Participants • Measure Analysis Population Description: Data reported for the Enrolled Population
|
17 participants
n=32 Participants • Measure Analysis Population Description: Data reported for Efficacy Population
|
16 participants
n=31 Participants • Measure Analysis Population Description: Data reported for Efficacy Population
|
33 participants
n=63 Participants • Measure Analysis Population Description: Data reported for Efficacy Population
|
|
Region of Enrollment
Italy
|
25 Participants
n=106 Participants • Measure Analysis Population Description: Data reported for the Enrolled Population
|
9 participants
n=32 Participants • Measure Analysis Population Description: Data reported for Efficacy Population
|
9 participants
n=31 Participants • Measure Analysis Population Description: Data reported for Efficacy Population
|
18 participants
n=63 Participants • Measure Analysis Population Description: Data reported for Efficacy Population
|
|
Region of Enrollment
France
|
10 Participants
n=106 Participants • Measure Analysis Population Description: Data reported for the Enrolled Population
|
3 participants
n=32 Participants • Measure Analysis Population Description: Data reported for Efficacy Population
|
4 participants
n=31 Participants • Measure Analysis Population Description: Data reported for Efficacy Population
|
7 participants
n=63 Participants • Measure Analysis Population Description: Data reported for Efficacy Population
|
|
Region of Enrollment
Finland
|
1 Participants
n=106 Participants • Measure Analysis Population Description: Data reported for the Enrolled Population
|
—
|
—
|
1 Participants
n=106 Participants • Measure Analysis Population Description: Data reported for the Enrolled Population
|
PRIMARY outcome
Timeframe: From the end of the Stable Dose Period to the end of the Double-blind Treatment Period (2 weeks)Double-blind comparison of the change in weekly number of cataplexy attacks from the last 2 weeks of the Stable Dose Period to the 2 weeks of the Double-blind Treatment Period.
Outcome measures
| Measure |
Xyrem
n=31 Participants
Active Xyrem continued as a double-blind treatment at the stable dose taken and regimen used in the prior 2 weeks.
|
Xyrem Placebo
n=32 Participants
Xyrem placebo was initiated as a double-blind treatment at a volume and regimen equivalent to the Xyrem dose taken in the prior 2 weeks.
|
|---|---|---|
|
Change in Weekly Number of Cataplexy Attacks
|
0.27 number of attacks
Interval -1.0 to 2.5
|
12.71 number of attacks
Interval 3.44 to 19.77
|
SECONDARY outcome
Timeframe: From the end of the Stable Dose Period to the end of the Double-blind Treatment Period (2 weeks)CGIc for cataplexy severity from the end of the Stable Dose Period to the end of the Double-blind Treatment Period. The CGIc is a 7-point scale ranging from "very much improved" to "very much worse." A score of 0 = no change, a score of 3 = very much improved, and a score of -3 = very much worse.
Outcome measures
| Measure |
Xyrem
n=29 Participants
Active Xyrem continued as a double-blind treatment at the stable dose taken and regimen used in the prior 2 weeks.
|
Xyrem Placebo
n=32 Participants
Xyrem placebo was initiated as a double-blind treatment at a volume and regimen equivalent to the Xyrem dose taken in the prior 2 weeks.
|
|---|---|---|
|
Clinical Global Impression of Change (CGIc) for Cataplexy Severity
|
-0.4 score on a scale
Standard Deviation 1.12
|
-1.5 score on a scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: From the end of the Stable Dose Period to the end of the Double-blind Treatment Period (2 weeks)Change in the ESS (CHAD) score from the end of the Stable Dose Period to the end of the Double-blind Treatment Period. The ESS is a self-administered questionnaire with 8 questions. It provides a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. In the ESS for children and adolescents (CHAD), certain activities were modified. 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.
Outcome measures
| Measure |
Xyrem
n=30 Participants
Active Xyrem continued as a double-blind treatment at the stable dose taken and regimen used in the prior 2 weeks.
|
Xyrem Placebo
n=31 Participants
Xyrem placebo was initiated as a double-blind treatment at a volume and regimen equivalent to the Xyrem dose taken in the prior 2 weeks.
|
|---|---|---|
|
Change in the Epworth Sleepiness Scale (ESS) (CHAD) Score
|
0.0 score on a scale
Interval -1.0 to 2.0
|
3.0 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: From the end of the Stable Dose Period to the end of the Double-blind Treatment Period (2 weeks)CGIc for narcolepsy overall from the end of the Stable Dose Period to the end of the Double-blind Treatment Period. The CGIc is a 7-point scale ranging from "very much improved" to "very much worse." A score of 0 = no change, a score of 3 = very much improved, and a score of -3 = very much worse.
Outcome measures
| Measure |
Xyrem
n=29 Participants
Active Xyrem continued as a double-blind treatment at the stable dose taken and regimen used in the prior 2 weeks.
|
Xyrem Placebo
n=32 Participants
Xyrem placebo was initiated as a double-blind treatment at a volume and regimen equivalent to the Xyrem dose taken in the prior 2 weeks.
|
|---|---|---|
|
CGIc for Narcolepsy Overall
|
-0.4 score on a scale
Standard Deviation 0.95
|
-1.4 score on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: From the end of the Stable Dose Period to the end of the Double-blind Treatment Period (2 weeks)The SF-10 Health Survey for Children is a parent-completed survey that contains 10 questions adapted from the Child Health Questionnaire. The SF-10 is intended to produce physical and psychosocial health summary measures. Each of the 10 questions responses is scored with a point value from 1 to 6 (1 is the worst possible condition and 6 is the best possible condition). The SF-10 physical and psychosocial measures are scored such that higher scores indicate more favorable functioning. The questions and associated point values are separated into the Physical Health (PHS-10 domain) and Psychosocial Health (PSS-10 domain). The sums of the scores in each domain are standardized using the mean and standard deviation from a normal population (2006 sample). The standardized scores are transformed to norm based scoring (NBS) metric. Through NBS, scale scores are standardized to a mean of 50 and SD of 10 in the combined U.S. general population and clinical samples. NBS scores are reported
Outcome measures
| Measure |
Xyrem
n=30 Participants
Active Xyrem continued as a double-blind treatment at the stable dose taken and regimen used in the prior 2 weeks.
|
Xyrem Placebo
n=30 Participants
Xyrem placebo was initiated as a double-blind treatment at a volume and regimen equivalent to the Xyrem dose taken in the prior 2 weeks.
|
|---|---|---|
|
Change in Quality of Life (QoL; SF-10 Physical and Psychosocial Summary Score) From the End of the Stable Dose Period to the End of the Double-blind Treatment Period
SF-10 Physical Summary Score
|
0 score on a scale
Interval -2.73 to 2.5
|
0 score on a scale
Interval -8.42 to 2.73
|
|
Change in Quality of Life (QoL; SF-10 Physical and Psychosocial Summary Score) From the End of the Stable Dose Period to the End of the Double-blind Treatment Period
SF-10 Psychosocial Summary Score
|
0 score on a scale
Interval -6.24 to 2.68
|
-2.670 score on a scale
Interval -8.02 to 2.67
|
Adverse Events
Safety Population
Serious events: 2 serious events
Other events: 80 other events
Deaths: 0 deaths
Randomized Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Population
n=104 participants at risk
Safety population who took study drug
|
Randomized Placebo
n=32 participants at risk
Subjects assigned to the Randomized Placebo group during the Double-blind Treatment Period. Adverse events with onset on or after the first dose in the Double-blind Treatment Period and prior to the date of first dose in the Open-label Safety Period are presented.
|
|---|---|---|
|
Psychiatric disorders
Acute Psychosis
|
0.96%
1/104 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
0.00%
0/32 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.96%
1/104 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
0.00%
0/32 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
Other adverse events
| Measure |
Safety Population
n=104 participants at risk
Safety population who took study drug
|
Randomized Placebo
n=32 participants at risk
Subjects assigned to the Randomized Placebo group during the Double-blind Treatment Period. Adverse events with onset on or after the first dose in the Double-blind Treatment Period and prior to the date of first dose in the Open-label Safety Period are presented.
|
|---|---|---|
|
Renal and urinary disorders
Enuresis
|
19.2%
20/104 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
3.1%
1/32 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
|
Gastrointestinal disorders
Nausea
|
19.2%
20/104 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
0.00%
0/32 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
|
Gastrointestinal disorders
Vomiting
|
18.3%
19/104 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
0.00%
0/32 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
|
Nervous system disorders
Headache
|
17.3%
18/104 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
0.00%
0/32 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
|
Investigations
Weight decreased
|
11.5%
12/104 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
3.1%
1/32 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.7%
9/104 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
0.00%
0/32 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
9/104 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
0.00%
0/32 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.7%
9/104 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
0.00%
0/32 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
|
Nervous system disorders
Dizziness
|
7.7%
8/104 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
0.00%
0/32 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
|
Nervous system disorders
Somnolence
|
1.9%
2/104 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
21.9%
7/32 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
|
Nervous system disorders
Cataplexy
|
1.9%
2/104 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
18.8%
6/32 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
|
Psychiatric disorders
Sleep disorder
|
0.96%
1/104 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
|
6.2%
2/32 • Safety data are provided through the 120 day update.
The Safety Population included all subjects who took study drug, and consisted of 104 subjects. There are 2 subjects included in the Enrolled Population who were dispensed study drug, but did not take the medication and were subsequently discontinued. As a result, safety analyses focused on the 104 subjects in the Safety Population. Adverse events are reported by the Safety Population in order to capture adverse events occurring across all treatment periods.
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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