Trial · NCT02348632
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
NCT02348632, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2019-06-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. "A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA". Trials, record NCT02348632. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02348632
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- "A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
- NCT number
- NCT02348632
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 645 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Narcolepsy, Obstructive Sleep Apnea
- Interventions
- JZP-110
- First posted
- 2015-01-28
- Last updated
- 2019-06-25
- Results first posted
- 2019-06-25
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Epworth Sleepiness Scale (ESS) Score | Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks) | Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. 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. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period. |
| Secondary | Subjects Reported as Worse on the Patient Global Impression of Change (PGIc) | Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks) | Percentage of subjects reported as worse (minimally worse, much worse, or very much worse) on the PGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. |
| Secondary | Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc) | Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks) | Subjects reported as worse (very much worse, much worse, and minimally worse) on the CGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Epworth Sleepiness Scale (ESS) Score | Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks) | 282 subjects were randomized into the randomized withdrawal period. Two subjects who were treated in the randomized withdrawal period did not have evaluable efficacy data during that period. Therefore, the mITT Population comprised 280 subjects, 141 who received placebo and 139 who received JZP-110. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Subjects Reported as Worse on the Patient Global Impression of Change (PGIc) | Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks) | 282 subjects were randomized into the randomized withdrawal period. Two subjects who were treated in the randomized withdrawal period did not have evaluable efficacy data during that period. Therefore, the mITT Population comprised 280 subjects, 141 who received placebo and 139 who received JZP-110. | percentage of subjects | NUMBER |
| SECONDARY | Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc) | Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks) | 282 subjects were randomized into the randomized withdrawal period. Two subjects who were treated in the randomized withdrawal period did not have evaluable efficacy data during that period. Therefore, the mITT Population comprised 280 subjects, 141 who received placebo and 139 who received JZP-110. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Epworth Sleepiness Scale (ESS) Score | JZP-110 | 1.6 | Standard Error 0.41 | points on a scale | |
| Change in Epworth Sleepiness Scale (ESS) Score | Placebo | 5.3 | Standard Error 0.41 | points on a scale | |
| Subjects Reported as Worse on the Patient Global Impression of Change (PGIc) | JZP-110 | 28.2 | percentage of subjects | ||
| Subjects Reported as Worse on the Patient Global Impression of Change (PGIc) | Placebo | 64.5 | percentage of subjects | ||
| Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc) | JZP-110 | 28.7 | percentage of subjects | ||
| Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc) | Placebo | 63.8 | percentage of subjects |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label Period | STARTED | JZP-110 | 643 | |
| Open-label Period | STARTED | Placebo | 0 | |
| Open-label Period | COMPLETED | JZP-110 | 458 | |
| Open-label Period | COMPLETED | Placebo | 0 | |
| Open-label Period | NOT COMPLETED | JZP-110 | 185 | |
| Open-label Period | NOT COMPLETED | Placebo | 0 | |
| Randomized Withdrawal Period | STARTED | JZP-110 | 140 | |
| Randomized Withdrawal Period | STARTED | Placebo | 142 | |
| Randomized Withdrawal Period | COMPLETED | JZP-110 | 137 | |
| Randomized Withdrawal Period | COMPLETED | Placebo | 141 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events110
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 | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | JZP-110 | 71 | 643 | |
| other | Headache | Nervous system disorders | Placebo | 0 | 142 | |
| other | Anxiety | Psychiatric disorders | JZP-110 | 46 | 643 | |
| other | Anxiety | Psychiatric disorders | Placebo | 0 | 142 | |
| other | Insomnia | Psychiatric disorders | JZP-110 | 51 | 643 | |
| other | Insomnia | Psychiatric disorders | Placebo | 1 | 142 | |
| other | Nausea | Gastrointestinal disorders | JZP-110 | 57 | 643 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 142 | |
| other | Dry mouth | Gastrointestinal disorders | JZP-110 | 47 | 643 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 0 | 142 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | JZP-110 | 1 | 643 |
| Total, all-cause mortality | Placebo | 0 | 142 |
| Total, other adverse events | JZP-110 | 269 | 643 |
| Total, other adverse events | Placebo | 3 | 142 |
| Total, serious adverse events | JZP-110 | 27 | 643 |
| Total, serious adverse events | Placebo | 0 | 142 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| JZP-110 vs Placebo: deaths from any cause | Trial comparisons |
| JZP-110 vs Placebo: serious adverse events | Trial comparisons |
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02348632
GET https://conductscience.org/api/trials/v1/NCT02348632/events?page=2