Trial · NCT02348606

"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"

NCT02348606, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2019-07-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA". Trials, record NCT02348606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02348606

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
NCT number: NCT02348606
Status: Completed
Phases: Phase 3
Enrollment: 476 participants, actual
Lead sponsor: Jazz Pharmaceuticals
Conditions: Obstructive Sleep Apnea
Interventions: JZP-110, Placebo oral tablet
First posted: 2015-01-28
Last updated: 2019-07-23
Results first posted: 2019-07-23

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12	Baseline to Week 12	Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12.
Primary	Change in ESS Score From Baseline to Week 12	Baseline to Week 12	Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
Secondary	Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12	12 Weeks	Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since start of treatment on a 7-point scale ranging from 1 = very much improved to 7 = very much worse. This is the key secondary endpoint.
Secondary	Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12	Baseline and Week 12	Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at week 12.
Secondary	Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4	Baseline to Week 4	Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to week 4.
Secondary	Change in ESS Score From Baseline to Week 1, Week 4, and Week 8	Baseline to Weeks 1, 4, and 8	Change in Epworth Sleepiness Scale (ESS) score from Baseline to Weeks 1, 4, and 8. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
Secondary	Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8	Weeks 1, 4, and 8	Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 1, Week 4, and Week 8. PGIc was rated by subjects and measures the change in their condition since treatment start on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.
Secondary	Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12	Week 12	Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 12. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.
Secondary	Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8	Weeks 1, 4, and 8	Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 1, Week 4, and Week 8. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12	Baseline to Week 12	Fifteen subjects in the Safety Population were excluded from the Modified Intent-to Treat (mITT) Population resulting in a total of 459 subjects.	minutes	LEAST_SQUARES_MEAN
PRIMARY	Change in ESS Score From Baseline to Week 12	Baseline to Week 12	Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.	points on a scale	LEAST_SQUARES_MEAN
SECONDARY	Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12	12 Weeks	Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.	percentage of subjects	NUMBER
SECONDARY	Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12	Baseline and Week 12	Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.	minutes	LEAST_SQUARES_MEAN
SECONDARY	Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4	Baseline to Week 4	Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.	minutes	LEAST_SQUARES_MEAN
SECONDARY	Change in ESS Score From Baseline to Week 1, Week 4, and Week 8	Baseline to Weeks 1, 4, and 8		points on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8	Weeks 1, 4, and 8	Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.	percentage of subjects	NUMBER
SECONDARY	Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12	Week 12	Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.	percentage of subjects	NUMBER
SECONDARY	Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8	Weeks 1, 4, and 8	Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.	percentage of subjects	NUMBER

Source ClinicalTrials.gov

Results by group95

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12	37.5 mg of JZP-110	4.74	Standard Error 1.418	minutes
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12	75 mg of JZP-110	9.08	Standard Error 1.358	minutes
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12	150 mg of JZP-110	10.96	Standard Error 0.973	minutes
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12	300 mg of JZP-110	12.99	Standard Error 1.038	minutes
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12	Placebo	0.21	Standard Error 0.997	minutes
Change in ESS Score From Baseline to Week 12	37.5 mg of JZP-110	-5.1	Standard Error 0.64	points on a scale
Change in ESS Score From Baseline to Week 12	75 mg of JZP-110	-5.0	Standard Error 0.62	points on a scale
Change in ESS Score From Baseline to Week 12	150 mg of JZP-110	-7.7	Standard Error 0.44	points on a scale
Change in ESS Score From Baseline to Week 12	300 mg of JZP-110	-7.9	Standard Error 0.46	points on a scale
Change in ESS Score From Baseline to Week 12	Placebo	-3.3	Standard Error 0.45	points on a scale

1 to 10 of 95Source ClinicalTrials.gov

See all 95 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	37.5 mg of JZP-110	58
Overall Study	STARTED	75 mg of JZP-110	62
Overall Study	STARTED	150 mg of JZP-110	117
Overall Study	STARTED	300 mg of JZP-110	118
Overall Study	STARTED	Placebo	119
Overall Study	COMPLETED	37.5 mg of JZP-110	49
Overall Study	COMPLETED	75 mg of JZP-110	54
Overall Study	COMPLETED	150 mg of JZP-110	106
Overall Study	COMPLETED	300 mg of JZP-110	94
Overall Study	COMPLETED	Placebo	101

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events95

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	37.5 mg of JZP-110	4	58
other	Headache	Nervous system disorders	75 mg of JZP-110	5	62
other	Headache	Nervous system disorders	150 mg of JZP-110	10	117
other	Headache	Nervous system disorders	300 mg of JZP-110	17	118
other	Headache	Nervous system disorders	Placebo	10	119
other	Feeling jittery	General disorders	37.5 mg of JZP-110	3	58
other	Feeling jittery	General disorders	75 mg of JZP-110	3	62
other	Feeling jittery	General disorders	150 mg of JZP-110	1	117
other	Feeling jittery	General disorders	300 mg of JZP-110	7	118
other	Feeling jittery	General disorders	Placebo	0	119

1 to 10 of 95Source ClinicalTrials.gov

See all 95 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	37.5 mg of JZP-110	0	58
Total, all-cause mortality	75 mg of JZP-110	0	62
Total, all-cause mortality	150 mg of JZP-110	0	117
Total, all-cause mortality	300 mg of JZP-110	0	118
Total, all-cause mortality	Placebo	0	119
Total, other adverse events	37.5 mg of JZP-110	17	58
Total, other adverse events	75 mg of JZP-110	21	62
Total, other adverse events	150 mg of JZP-110	41	117
Total, other adverse events	300 mg of JZP-110	60	118
Total, other adverse events	Placebo	30	119

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30521757	DERIVED	PubMed
32353246	DERIVED	PubMed
33226332	DERIVED	PubMed
33394323	DERIVED	PubMed
33631141	DERIVED	PubMed
34283019	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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