Trial · NCT02348593
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
NCT02348593, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2019-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy". Trials, record NCT02348593. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02348593
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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 Narcolepsy"
- NCT number
- NCT02348593
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 239 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Narcolepsy
- 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. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing. |
| 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 | Baseline to Week 12 | 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 treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse |
| Secondary | Change in Sleep Latency Time on MWT Trial 1 at Week 12 | Change from baseline for sleep latency in MWT during trial 1 at 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 Sleep Latency Time on MWT Trial 2 at Week 12 | Change from baseline for sleep latency in MWT during trial 2 at 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 Sleep Latency Time on MWT Trial 3 at Week 12 | Change from baseline for sleep latency in MWT during trial 3 at 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 Sleep Latency Time on MWT Trial 4 at Week 12 | Change from baseline for sleep latency in MWT during trial 4 at 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 Sleep Latency Time on MWT Trial 5 at Week 12 | Change from baseline for sleep latency in MWT during trial 5 at 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. |
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 | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Change in ESS Score From Baseline to Week 12 | Baseline to Week 12 | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12 | Baseline to Week 12 | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | percentage of subjects | NUMBER |
| SECONDARY | Change in Sleep Latency Time on MWT Trial 1 at Week 12 | Change from baseline for sleep latency in MWT during trial 1 at week 12 | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Sleep Latency Time on MWT Trial 2 at Week 12 | Change from baseline for sleep latency in MWT during trial 2 at week 12 | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Sleep Latency Time on MWT Trial 3 at Week 12 | Change from baseline for sleep latency in MWT during trial 3 at week 12 | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Sleep Latency Time on MWT Trial 4 at Week 12 | Change from baseline for sleep latency in MWT during trial 4 at week 12 | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Sleep Latency Time on MWT Trial 5 at Week 12 | Change from baseline for sleep latency in MWT during trial 5 at week 12 | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 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 | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | minutes | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 | Placebo | 2.12 | Standard Error 1.289 | minutes | |
| Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 | 75 mg of JZP-110 | 4.74 | Standard Error 1.335 | minutes | |
| Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 | 150 mg JZP-110 | 9.77 | Standard Error 1.327 | minutes | |
| Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 | 300 mg of JZP-110 | 12.27 | Standard Error 1.389 | minutes | |
| Change in ESS Score From Baseline to Week 12 | Placebo | -1.6 | Standard Error 0.65 | points on a scale | |
| Change in ESS Score From Baseline to Week 12 | 75 mg of JZP-110 | -3.8 | Standard Error 0.67 | points on a scale | |
| Change in ESS Score From Baseline to Week 12 | 150 mg JZP-110 | -5.4 | Standard Error 0.66 | points on a scale | |
| Change in ESS Score From Baseline to Week 12 | 300 mg of JZP-110 | -6.4 | Standard Error 0.68 | points on a scale | |
| Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12 | Placebo | 39.7 | percentage of subjects | ||
| Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12 | 75 mg of JZP-110 | 67.8 | percentage of subjects |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 75 mg of JZP-110 | 59 | |
| Overall Study | STARTED | 150 mg JZP-110 | 59 | |
| Overall Study | STARTED | 300 mg of JZP-110 | 59 | |
| Overall Study | STARTED | Placebo | 59 | |
| Overall Study | COMPLETED | 75 mg of JZP-110 | 49 | |
| Overall Study | COMPLETED | 150 mg JZP-110 | 51 | |
| Overall Study | COMPLETED | 300 mg of JZP-110 | 43 | |
| Overall Study | COMPLETED | Placebo | 52 | |
| Overall Study | NOT COMPLETED | 75 mg of JZP-110 | 10 | |
| Overall Study | NOT COMPLETED | 150 mg JZP-110 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events76
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 | Weight decreased | Investigations | Placebo | 0 | 59 | |
| other | Weight decreased | Investigations | 75 mg of JZP-110 | 1 | 59 | |
| other | Weight decreased | Investigations | 150 mg JZP-110 | 1 | 59 | |
| other | Weight decreased | Investigations | 300 mg of JZP-110 | 3 | 59 | |
| other | Heart rate increased | Investigations | Placebo | 0 | 59 | |
| other | Heart rate increased | Investigations | 75 mg of JZP-110 | 0 | 59 | |
| other | Heart rate increased | Investigations | 150 mg JZP-110 | 0 | 59 | |
| other | Heart rate increased | Investigations | 300 mg of JZP-110 | 4 | 59 | |
| other | Weight increased | Investigations | Placebo | 3 | 59 | |
| other | Weight increased | Investigations | 75 mg of JZP-110 | 2 | 59 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 59 |
| Total, all-cause mortality | 75 mg of JZP-110 | 0 | 59 |
| Total, all-cause mortality | 150 mg JZP-110 | 0 | 59 |
| Total, all-cause mortality | 300 mg of JZP-110 | 0 | 59 |
| Total, other adverse events | Placebo | 17 | 59 |
| Total, other adverse events | 75 mg of JZP-110 | 19 | 59 |
| Total, other adverse events | 150 mg JZP-110 | 32 | 59 |
| Total, other adverse events | 300 mg of JZP-110 | 36 | 59 |
| Total, serious adverse events | Placebo | 0 | 59 |
| Total, serious adverse events | 75 mg of JZP-110 | 0 | 59 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
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 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.
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/NCT02348593
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