Trial Outcomes & Findings for A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy (NCT NCT05875974)
NCT ID: NCT05875974
Last Updated: 2026-08-27
Results Overview
The ESS total score (the sum of 8 item scores, each 0 to 3) can range from 0 to 24. Higher ESS total scores are associated with higher sleep propensity in daily life, also referred to as "daytime sleepiness."
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
199 participants
Primary outcome timeframe
Baseline up to End of Treatment (approximately 10-36 weeks)
Results posted on
2026-08-27
Participant Flow
The Enrolled Analysis Set included n=66 Idiopathic Hypersomnia; n=68 Narcolepsy; n=65 \> 9-g Narcolepsy. Each cohort has a cohort-specific ICF and a unique set of protocol specified assessments/procedures. Participants in the \>9-g Narcolepsy cohort were either already taking 9 g/night of Xywav at screening or had titrated to 9 g of Xywav while in the Narcolepsy cohort, discontinued from this cohort, and signed a new ICF to begin the \>9-g Narcolepsy cohort (referred to as "transfer participants").
Participant milestones
| Measure |
Idiopathic Hypersomnia (IH)
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
Exploratory > 9-g Narcolepsy
Participants received a Xywav dosage for \> 9 up to 12 g/night divided into 2 doses (maximum 7.5 g for the first dose and maximum 4.5 g for the second dose, with the first dose taken at bedtime and the second taken approximately 4 hours later). Of the 13 transfer participants, one screen failed and one met eligibility criteria, but due to an adverse event, never dose escalated \> 9.0 grams.
|
|---|---|---|---|
|
Screening Period
STARTED
|
66
|
68
|
65
|
|
Screening Period
COMPLETED
|
46
|
55
|
51
|
|
Screening Period
NOT COMPLETED
|
20
|
13
|
14
|
|
Treatment Period
STARTED
|
46
|
55
|
48
|
|
Treatment Period
Transferred From Narcolepsy Cohort and Received >9g Treatment
|
0
|
0
|
11
|
|
Treatment Period
COMPLETED
|
40
|
34
|
44
|
|
Treatment Period
NOT COMPLETED
|
6
|
21
|
4
|
Reasons for withdrawal
| Measure |
Idiopathic Hypersomnia (IH)
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
Exploratory > 9-g Narcolepsy
Participants received a Xywav dosage for \> 9 up to 12 g/night divided into 2 doses (maximum 7.5 g for the first dose and maximum 4.5 g for the second dose, with the first dose taken at bedtime and the second taken approximately 4 hours later). Of the 13 transfer participants, one screen failed and one met eligibility criteria, but due to an adverse event, never dose escalated \> 9.0 grams.
|
|---|---|---|---|
|
Screening Period
Screen failures
|
20
|
13
|
14
|
|
Treatment Period
Adverse Event
|
1
|
2
|
2
|
|
Treatment Period
Physician Decision
|
2
|
0
|
0
|
|
Treatment Period
Protocol deviation
|
1
|
1
|
0
|
|
Treatment Period
Withdrawal by Subject
|
2
|
3
|
1
|
|
Treatment Period
Pregnancy
|
0
|
1
|
0
|
|
Treatment Period
Sponsor request
|
0
|
1
|
0
|
|
Treatment Period
Noncompliance with study schedule
|
0
|
0
|
1
|
|
Treatment Period
Transferred to > 9-g Narcolepsy Cohort
|
0
|
13
|
0
|
Baseline Characteristics
As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
Baseline characteristics by cohort
| Measure |
Idiopathic Hypersomnia (IH)
n=46 Participants
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
n=55 Participants
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
Exploratory > 9-g Narcolepsy
n=48 Participants
Participants received a Xywav dosage for \> 9 up to 12 g/night divided into 2 doses (maximum 7.5 g for the first dose and maximum 4.5 g for the second dose, with the first dose taken at bedtime and the second taken approximately 4 hours later).
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
Exploratory >9-g Narcolepsy cohort · Unknown
|
—
|
—
|
2 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
2 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Age, Continuous
IH and Narcolepsy cohorts
|
38.1 years
STANDARD_DEVIATION 11.77 • n=46 Participants • Each cohort is treated independently as outlined in the participant flow. The Total column is not reported for any DUET analyses. The Narcolepsy and \>9g Narcolepsy cohorts are shown on two separate rows for the baseline characteristics..
|
33.4 years
STANDARD_DEVIATION 12.87 • n=55 Participants • Each cohort is treated independently as outlined in the participant flow. The Total column is not reported for any DUET analyses. The Narcolepsy and \>9g Narcolepsy cohorts are shown on two separate rows for the baseline characteristics..
|
—
|
35.6 years
STANDARD_DEVIATION 12.5 • n=101 Participants • Each cohort is treated independently as outlined in the participant flow. The Total column is not reported for any DUET analyses. The Narcolepsy and \>9g Narcolepsy cohorts are shown on two separate rows for the baseline characteristics..
|
|
Age, Continuous
Exploratory >9-g Narcolepsy cohort
|
—
|
—
|
39.2 years
STANDARD_DEVIATION 10.92 • n=48 Participants • Each cohort is treated independently as outlined in the participant flow. The Total column is not reported for any DUET analyses. The Narcolepsy and \>9g Narcolepsy cohorts are shown on two separate rows for the baseline characteristics..
|
39.2 years
STANDARD_DEVIATION 10.92 • n=48 Participants • Each cohort is treated independently as outlined in the participant flow. The Total column is not reported for any DUET analyses. The Narcolepsy and \>9g Narcolepsy cohorts are shown on two separate rows for the baseline characteristics..
|
|
Sex/Gender, Customized
IH and Narcolepsy cohorts · Male (at birth)
|
9 Participants
n=46 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
15 Participants
n=55 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
—
|
24 Participants
n=101 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Sex/Gender, Customized
IH and Narcolepsy cohorts · Female (at birth)
|
37 Participants
n=46 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
40 Participants
n=55 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
—
|
77 Participants
n=101 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Sex/Gender, Customized
Exploratory >9-g Narcolepsy cohort · Male (at birth)
|
—
|
—
|
18 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
18 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Sex/Gender, Customized
Exploratory >9-g Narcolepsy cohort · Female (at birth)
|
—
|
—
|
30 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
30 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Race/Ethnicity, Customized
IH and Narcolepsy cohorts · Asian
|
2 Participants
n=46 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
2 Participants
n=55 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
—
|
4 Participants
n=101 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Race/Ethnicity, Customized
IH and Narcolepsy cohorts · Black or African American
|
3 Participants
n=46 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
7 Participants
n=55 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
—
|
10 Participants
n=101 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Race/Ethnicity, Customized
IH and Narcolepsy cohorts · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=46 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
0 Participants
n=55 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
—
|
1 Participants
n=101 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Race/Ethnicity, Customized
IH and Narcolepsy cohorts · White
|
39 Participants
n=46 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
44 Participants
n=55 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
—
|
83 Participants
n=101 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Race/Ethnicity, Customized
IH and Narcolepsy cohorts · Multiple
|
1 Participants
n=46 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
1 Participants
n=55 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
—
|
2 Participants
n=101 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Race/Ethnicity, Customized
IH and Narcolepsy cohorts · Unknown
|
0 Participants
n=46 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
1 Participants
n=55 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
—
|
1 Participants
n=101 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Race/Ethnicity, Customized
Exploratory >9-g Narcolepsy cohort · Asian
|
—
|
—
|
1 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
1 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Race/Ethnicity, Customized
Exploratory >9-g Narcolepsy cohort · Black or African American
|
—
|
—
|
7 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
7 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Race/Ethnicity, Customized
Exploratory >9-g Narcolepsy cohort · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
0 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Race/Ethnicity, Customized
Exploratory >9-g Narcolepsy cohort · White
|
—
|
—
|
37 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
37 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
|
Race/Ethnicity, Customized
Exploratory >9-g Narcolepsy cohort · Multiple
|
—
|
—
|
1 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
1 Participants
n=48 Participants • As advised, baseline demographics of the IH and Narcolepsy cohorts were reported on different rows, separately from the Exploratory \>9-g Narcolepsy cohort.
|
PRIMARY outcome
Timeframe: Baseline up to End of Treatment (approximately 10-36 weeks)Population: Epworth Sleepiness Scale (ESS) Total Score was assessed in IH and narcolepsy participants with available data in the Completer Set. ESS in the \>9g narcolepsy cohort was exploratory and are not presented.
The ESS total score (the sum of 8 item scores, each 0 to 3) can range from 0 to 24. Higher ESS total scores are associated with higher sleep propensity in daily life, also referred to as "daytime sleepiness."
Outcome measures
| Measure |
Idiopathic Hypersomnia (IH)
n=40 Participants
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
n=34 Participants
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
|---|---|---|
|
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score in Participants With IH and Narcolepsy Treated With XYWAV
|
-8.38 score on a scale
Standard Error 0.695
|
-7.68 score on a scale
Standard Error 0.931
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (approximately 10-21 weeks)Population: Idiopathic Hypersomnia Severity Scale (IHSS) Total Score was assessed only in IH participants with available data in the Completer Set. IHSS was not assessed in the Narcolepsy cohorts.
The IHSS is a 14-item self-reported instrument that assesses the severity and functional consequences of IH symptoms. Questions capture symptoms of excessive sleepiness, sleep inertia, and long sleep duration. IHSS total scores range from 0 to 50 with higher score indicating worse clinical outcome.
Outcome measures
| Measure |
Idiopathic Hypersomnia (IH)
n=36 Participants
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
|---|---|---|
|
Change From Baseline in Idiopathic Hypersomnia Severity Scale (IHSS) Total Score in Participants With IH Treated With XYWAV
|
-15.53 score on a scale
Standard Error 1.490
|
—
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (approximately 10-36 weeks)Population: Stage shifts were assessed in narcolepsy participants with available data in the Completer Set. Sleep stage shift outcomes in the IH and \>9g narcolepsy cohorts were exploratory and are not presented.
Stage shifts of sleep are defined as the count of transitions of bouts of sleep from deeper to lighter stages of sleep/wake (ie from N3/N2/N1/REM to wake and from N3/N2/REM to N1).
Outcome measures
| Measure |
Idiopathic Hypersomnia (IH)
n=34 Participants
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
|---|---|---|
|
Change From Baseline in Number of Stage Shifts of Sleep in Participants With Narcolepsy Treated With XYWAV
|
-13.06 stage shifts
Standard Error 2.908
|
—
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (approximately 10-36 weeks)Population: Duration of sleep stages was assessed in narcolepsy participants with available data in the Completer Set. Duration of sleep stage outcomes in the IH and \>9g narcolepsy cohorts were exploratory and are not presented.
Duration of sleep stages is measured in minutes (ie N1/N2/N3/REM) and is recorded from sleep onset to awakening during the nocturnal polysomnograph.
Outcome measures
| Measure |
Idiopathic Hypersomnia (IH)
n=34 Participants
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
|---|---|---|
|
Change From Baseline in Duration of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Stage N1 Sleep Duration: Full Night, Visit 4 (End of Treatment)
|
-8.12 minutes
Standard Error 3.303
|
—
|
|
Change From Baseline in Duration of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Stage N2 Sleep Duration: Full Night, Visit 4 (End of Treatment)
|
1.5 minutes
Standard Error 12.343
|
—
|
|
Change From Baseline in Duration of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Stage N3 Sleep Duration: Full Night, Visit 4 (End of Treatment)
|
45.01 minutes
Standard Error 8.822
|
—
|
|
Change From Baseline in Duration of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Stage REM Sleep Duration: Full Night, Visit 4 (End of Treatment)
|
-39.18 minutes
Standard Error 5.716
|
—
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (approximately 10-36 weeks)Population: Nocturnal awakenings and nocturnal arousals were assessed in narcolepsy participants with available data in the Completer Set. Nocturnal awakenings and arousals from the IH and \>9g narcolepsy cohorts were exploratory and are not presented.
Outcome measures
| Measure |
Idiopathic Hypersomnia (IH)
n=34 Participants
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
|---|---|---|
|
Change From Baseline in Number of Nocturnal Awakenings and Nocturnal Arousals in Participants With Narcolepsy Treated With XYWAV
Number of awakenings: Full Night, Visit 4 (End of Treatment)
|
-3.18 awakenings/arousals
Standard Error 0.903
|
—
|
|
Change From Baseline in Number of Nocturnal Awakenings and Nocturnal Arousals in Participants With Narcolepsy Treated With XYWAV
Total number of all arousals: Full Night, Visit 4 (End of Treatment
|
-23.88 awakenings/arousals
Standard Error 7.564
|
—
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (approximately 10-36 weeks)Population: Percentage of sleep stages were assessed in narcolepsy participants with available data in the Completer Set. Sleep stage outcomes for the IH and \>9g narcolepsy cohorts were exploratory and are not presented.
The percentage of sleep stages is measured as minutes of each sleep stage (N3/N2/N1/REM) per hour of sleep time from sleep onset to awakening in the nocturnal polysomnograph.
Outcome measures
| Measure |
Idiopathic Hypersomnia (IH)
n=34 Participants
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
|---|---|---|
|
Change From Baseline in Percentage of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Stage N1 Sleep/Total Sleep Time: Full Night, Visit 4 (End of Treatment)
|
-2.18 percentage of sleep stages
Standard Error 0.696
|
—
|
|
Change From Baseline in Percentage of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Stage N2 Sleep/Total Sleep Time: Full Night, Visit 4 (End of Treatment)
|
0.03 percentage of sleep stages
Standard Error 1.923
|
—
|
|
Change From Baseline in Percentage of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Stage N3 Sleep/Total Sleep Time: Full Night, Visit 4 (End of Treatment)
|
10.28 percentage of sleep stages
Standard Error 1.890
|
—
|
|
Change From Baseline in Percentage of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Stage REM Sleep/Total Sleep Time: Full Night, Visit 4 (End of Treatment)
|
-8.13 percentage of sleep stages
Standard Error 1.242
|
—
|
SECONDARY outcome
Timeframe: End of Treatment (approximately 10-36 weeks)Population: PGI-C was assessed in IH and narcolepsy participants with available data in the Completer Set. PGI-C outcome in the \>9g narcolepsy cohort was exploratory and are not presented.
The PGI-C is a single-item 7-point, Likert-type scale for rating change in disease or symptom severity. Responses for each question ranged from 1 (very much improved) to 7 (very much worse) relative to baseline. Participants rated the change from baseline in their overall (IH or narcolepsy) symptoms, sleep inertia (difficulty waking in the morning), and fatigue (extreme tiredness resulting from mental or physical exertion).
Outcome measures
| Measure |
Idiopathic Hypersomnia (IH)
n=37 Participants
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
n=30 Participants
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
|---|---|---|
|
Patient Global Impression of Change (PGI-C) in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue)
Minimally improved
|
9 Participants
|
5 Participants
|
|
Patient Global Impression of Change (PGI-C) in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue)
No change
|
1 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGI-C) in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue)
Minimally worse
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGI-C) in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue)
Very much improved
|
8 Participants
|
4 Participants
|
|
Patient Global Impression of Change (PGI-C) in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue)
Much improved
|
18 Participants
|
19 Participants
|
|
Patient Global Impression of Change (PGI-C) in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue)
Much worse
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGI-C) in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue)
Very much worse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (approximately 10-36 weeks)Population: Level of rested or refreshed upon awakening was assessed in IH and narcolepsy participants with available data in the Completer Set. Level of rested or refreshed upon awakening outcomes in the \>9g narcolepsy cohort were exploratory and are not presented.
The participant was asked "How rested or refreshed did you feel when you woke up for the day?"
Outcome measures
| Measure |
Idiopathic Hypersomnia (IH)
n=36 Participants
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
n=32 Participants
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
|---|---|---|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Baseline, Very well rested
|
0 Participants
|
0 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Baseline, Well rested
|
2 Participants
|
4 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Visit 4 End of Treatment, Sleep Quality Very poor
|
0 Participants
|
0 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Visit 4 End of Treatment, Sleep Quality Poor
|
2 Participants
|
0 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Visit 4 End of Treatment, Sleep Quality Fair
|
11 Participants
|
6 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Visit 4 End of Treatment, Sleep Quality Good
|
12 Participants
|
11 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Visit 4 End of Treatment, Sleep Quality Very Good
|
5 Participants
|
3 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Visit 4 End of Treatment, Slightly rested
|
2 Participants
|
2 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Visit 4 End of Treatment, Somewhat rested
|
12 Participants
|
7 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Visit 4 End of Treatment, Well rested
|
8 Participants
|
9 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Visit 4 End of Treatment, Very well rested
|
2 Participants
|
2 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Baseline, Sleep Quality Very poor
|
4 Participants
|
3 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Baseline, Sleep Quality Poor
|
12 Participants
|
14 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Baseline, Sleep Quality Fair
|
13 Participants
|
10 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Baseline, Sleep Quality Good
|
7 Participants
|
5 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Baseline, Sleep Quality Very Good
|
0 Participants
|
0 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Baseline, Not at all rested
|
11 Participants
|
4 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Baseline, Slightly rested
|
17 Participants
|
13 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Baseline, Somewhat rested
|
6 Participants
|
11 Participants
|
|
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Visit 4 End of Treatment, Not at all rested
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (approximately 10-36 weeks)Population: PGI-S scores were assessed in IH and narcolepsy participants with available data in the Completer Set. PGI-S outcomes in the \>9g narcolepsy cohort were exploratory and are not presented.
The PGI-S is a single-item, 7-point, Likert-type scale for rating disease or symptom severity. Responses ranged from 0 (not present) to 7 (extremely severe). Participants rated the severity of their overall (IH or narcolepsy) symptoms, sleep inertia, and fatigue. Higher scores indicate worse clinical outcome.
Outcome measures
| Measure |
Idiopathic Hypersomnia (IH)
n=40 Participants
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
n=34 Participants
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
|---|---|---|
|
Patient Global Impression of Severity (PGI-S) Score in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue)
Baseline
|
5.3 score on a scale
Standard Deviation 0.92
|
5.4 score on a scale
Standard Deviation 1.07
|
|
Patient Global Impression of Severity (PGI-S) Score in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue)
Visit 4, End of Treatment
|
3.8 score on a scale
Standard Deviation 1.33
|
3.6 score on a scale
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: PK: Predose, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour post-first dose and post-second dose, 6 hour post-first dose, 8 hour post-first dosePopulation: Pharmacokinetic parameters were assessed only in narcolepsy participants with available data in the Pharmacokinetic Analysis Set. PK was not assessed in the IH cohort. PK outcomes in the \>9g narcolepsy cohort were exploratory and are not presented.
Blood samples were processed to obtain plasma samples and then analyzed for oxybate concentrations using a validated bioanalytical method.
Outcome measures
| Measure |
Idiopathic Hypersomnia (IH)
n=3 Participants
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
|---|---|---|
|
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) In a Subset of Participants With Narcolepsy Treated With XYWAV
|
107.61 ug/mL
Standard Deviation 1.534
|
—
|
SECONDARY outcome
Timeframe: PK: Predose, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour post-first dose and post-second dose, 6 hour post-first dose, 8 hour post-first dosePopulation: Pharmacokinetic parameters were assessed only in narcolepsy participants with available data in the Pharmacokinetic Analysis Set. PK was not assessed in the IH cohort. PK outcomes in the \>9g narcolepsy cohort were exploratory and are not presented.
Blood samples were processed to obtain plasma samples and then analyzed for oxybate concentrations using a validated bioanalytical method.
Outcome measures
| Measure |
Idiopathic Hypersomnia (IH)
n=1 Participants
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
|---|---|---|
|
Pharmacokinetic Parameter Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) In a Subset of Participants With Narcolepsy Treated With XYWAV
|
474.00 h*µg/mL
Standard Deviation NA
SD cannot be calculated on 1 person.
|
—
|
Adverse Events
Idiopathic Hypersomnia (IH)
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Narcolepsy
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
> 9-g Narcolepsy
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Idiopathic Hypersomnia (IH)
n=46 participants at risk
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, , with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
n=55 participants at risk
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
> 9-g Narcolepsy
n=48 participants at risk
Participants took a Xywav dosage \> 9 up to 12 g/night divided into 2 doses (maximum 7.5 g for the first dose and maximum 4.5 g for the second dose, with the first dose taken at bedtime and the second taken approximately 4 hours later).
|
|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
0.00%
0/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
2.1%
1/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
0.00%
0/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
0.00%
0/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
Other adverse events
| Measure |
Idiopathic Hypersomnia (IH)
n=46 participants at risk
Participants with idiopathic hypersomnia (IH) received Xywav once or twice nightly. Participants who took a once-nightly regimen may have taken up to 6 g/night as a single dose. Participants who took a twice-nightly regimen may have taken up to 9 g/night as 2 divided doses, , with the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.
|
Narcolepsy
n=55 participants at risk
Participants with narcolepsy received a recommended effective dosage range up to 9 g/night divided (equally or unequally) into 2 doses, with the first dose taken at bedtime and the second taken 2.5 to 4 hours later.
|
> 9-g Narcolepsy
n=48 participants at risk
Participants took a Xywav dosage \> 9 up to 12 g/night divided into 2 doses (maximum 7.5 g for the first dose and maximum 4.5 g for the second dose, with the first dose taken at bedtime and the second taken approximately 4 hours later).
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
19.6%
9/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
23.6%
13/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
12.5%
6/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Nervous system disorders
Dizziness
|
17.4%
8/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
14.5%
8/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
0.00%
0/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Nervous system disorders
Headache
|
17.4%
8/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
12.7%
7/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
10.4%
5/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Gastrointestinal disorders
Vomiting
|
10.9%
5/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
10.9%
6/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
12.5%
6/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Psychiatric disorders
Middle insomnia
|
8.7%
4/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
3.6%
2/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
0.00%
0/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Psychiatric disorders
Anxiety
|
6.5%
3/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
7.3%
4/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
4.2%
2/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.5%
3/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
5.5%
3/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
2.1%
1/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Psychiatric disorders
Enuresis
|
6.5%
3/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
5.5%
3/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
8.3%
4/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Nervous system disorders
Somnolence
|
6.5%
3/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
10.9%
6/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
8.3%
4/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.3%
2/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
7.3%
4/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
4.2%
2/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
7.3%
4/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
2.1%
1/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Nervous system disorders
Brain fog
|
2.2%
1/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
5.5%
3/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
4.2%
2/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
2/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
5.5%
3/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
4.2%
2/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Nervous system disorders
Hypoaesthesia
|
2.2%
1/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
5.5%
3/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
0.00%
0/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
0.00%
0/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
6.2%
3/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
0.00%
0/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
6.2%
3/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Blood and lymphatic system disorders
Hypotension
|
0.00%
0/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
0.00%
0/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
6.2%
3/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Renal and urinary disorders
Pollakiuria
|
4.3%
2/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
0.00%
0/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
6.2%
3/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/46 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
1.8%
1/55 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
6.2%
3/48 • Adverse events were collected from Screening up to Safety Follow Up visit, approximately 14 weeks.
Transfer participants are not a separate cohort/group. For the transfer participants, AEs that occurred while in the narcolepsy cohort are reported within the narcolepsy cohort column. After transferring to the \>9g narcolepsy cohort, any AEs that occurred after dosing \>9g are captured in the \>9g cohort column.
|
Additional Information
Clinical Trial Disclosure & Transparency
Jazz Pharmaceuticals
Phone: 215-832-3750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place