Trial · NCT02348619
"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
NCT02348619, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2019-09-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. "Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA". Trials, record NCT02348619. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02348619
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- "Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
- NCT number
- NCT02348619
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 174 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Obstructive Sleep Apnea
- Interventions
- JZP-110
- First posted
- 2015-01-28
- Last updated
- 2019-09-09
- Results first posted
- 2019-09-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Maintenance of Wakefulness Test (MWT) | Week 4 to Week 6 | Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. Mean sleep latency defined as the average of the first four MWT trial's measurements. |
| Primary | Change in the Epworth Sleepiness Scale (ESS) | Week 4 to Week 6 | Change in Epworth Sleepiness Scale (ESS) score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. 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 week 4 to week 6. |
| Secondary | Patient Global Impression of Change (PGIc) | Week 4 to Week 6 | Percentage of subjects reported as worse (minimally, much, or very much) on the PGIc at the end of the Double-blind Withdrawal Phase. PGIc was rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse. |
| Secondary | Clinical Global Impression of Change (CGIc) | Week 4 to Week 6 | Percentage of subjects reported as worse (minimally, much, or very much) on the CGIc at the end of the Double-blind Withdrawal Phase. 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 | Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) | Week 4 to Week 6 | Change is total score from the end of the stable dose phase to the end of the double blind withdrawal phase. Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10) is a 10-item disease-specific quality of life questionnaire to assess the effect of excessiveness sleepiness on multiple activities of everyday living. The FOSQ-10 consists of 10 questions, each scored on a scale from 1-4. The questionnaire has a 4-point response format for each question (1 = extreme difficulty, 2 = moderate difficulty, 3 = a little difficulty, and 4 = no difficulty). The total score is derived by the mean of the 5 subscale scores, multiplied by 5, resulting in a possible range of scores between 5 to 20; lower FOSQ-10 scores are worse, indicating more difficulty carrying out activities; higher FOSQ-10 scores are better, indicating less difficulty carrying out activities. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Maintenance of Wakefulness Test (MWT) | Week 4 to Week 6 | minutes | LEAST_SQUARES_MEAN | |
| PRIMARY | Change in the Epworth Sleepiness Scale (ESS) | Week 4 to Week 6 | points on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Patient Global Impression of Change (PGIc) | Week 4 to Week 6 | percentage of subjects | NUMBER | |
| SECONDARY | Clinical Global Impression of Change (CGIc) | Week 4 to Week 6 | percentage of subjects | NUMBER | |
| SECONDARY | Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) | Week 4 to Week 6 | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Maintenance of Wakefulness Test (MWT) | JZP-110 | -0.96 | Standard Error 1.350 | minutes | |
| Change in the Maintenance of Wakefulness Test (MWT) | Placebo | -12.11 | Standard Error 1.326 | minutes | |
| Change in the Epworth Sleepiness Scale (ESS) | JZP-110 | -0.1 | Standard Error 0.73 | points on a scale | |
| Change in the Epworth Sleepiness Scale (ESS) | Placebo | 4.5 | Standard Error 0.71 | points on a scale | |
| Patient Global Impression of Change (PGIc) | JZP-110 | 20 | percentage of subjects | ||
| Patient Global Impression of Change (PGIc) | Placebo | 50 | percentage of subjects | ||
| Clinical Global Impression of Change (CGIc) | JZP-110 | 22 | percentage of subjects | ||
| Clinical Global Impression of Change (CGIc) | Placebo | 59 | percentage of subjects | ||
| Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) | JZP-110 | -0.15 | Standard Error 0.393 | units on a scale | |
| Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) | Placebo | -1.31 | Standard Error 0.381 | units on a scale |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Titration Phase | STARTED | JZP-110 | 174 | |
| Titration Phase | STARTED | Placebo | 0 | |
| Titration Phase | COMPLETED | JZP-110 | 157 | |
| Titration Phase | COMPLETED | Placebo | 0 | |
| Titration Phase | NOT COMPLETED | JZP-110 | 17 | |
| Titration Phase | NOT COMPLETED | Placebo | 0 | |
| Stable-Dose Phase | STARTED | JZP-110 | 157 | |
| Stable-Dose Phase | STARTED | Placebo | 0 | |
| Stable-Dose Phase | COMPLETED | JZP-110 | 124 | |
| Stable-Dose Phase | COMPLETED | Placebo | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events12
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 (Entire Study) | 20 | 174 | |
| other | Headache | Nervous system disorders | Placebo (Randomized Withdrawal) | 0 | 62 | |
| other | Dizziness | Nervous system disorders | JZP-110 (Entire Study) | 14 | 174 | |
| other | Dizziness | Nervous system disorders | Placebo (Randomized Withdrawal) | 0 | 62 | |
| other | Dry mouth | Gastrointestinal disorders | JZP-110 (Entire Study) | 13 | 174 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo (Randomized Withdrawal) | 0 | 62 | |
| other | Nausea | Gastrointestinal disorders | JZP-110 (Entire Study) | 13 | 174 | |
| other | Nausea | Gastrointestinal disorders | Placebo (Randomized Withdrawal) | 0 | 62 | |
| other | Insomnia | Psychiatric disorders | JZP-110 (Entire Study) | 11 | 174 | |
| other | Insomnia | Psychiatric disorders | Placebo (Randomized Withdrawal) | 0 | 62 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | JZP-110 (Entire Study) | 0 | 174 |
| Total, all-cause mortality | Placebo (Randomized Withdrawal) | 0 | 62 |
| Total, other adverse events | JZP-110 (Entire Study) | 58 | 174 |
| Total, other adverse events | Placebo (Randomized Withdrawal) | 0 | 62 |
| Total, serious adverse events | JZP-110 (Entire Study) | 0 | 174 |
| Total, serious adverse events | Placebo (Randomized Withdrawal) | 0 | 62 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30471270 | DERIVED |
Source 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| JZP-110 (Entire Study) vs Placebo (Randomized Withdrawal): deaths from any cause | Trial comparisons |
| JZP-110 (Entire Study) vs Placebo (Randomized Withdrawal): 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/NCT02348619
GET https://conductscience.org/api/trials/v1/NCT02348619/registered