Trial · NCT03533114
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
NCT03533114, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2021-11-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension. Trials, record NCT03533114. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03533114
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
- NCT number
- NCT03533114
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 154 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Idiopathic Hypersomnia
- Interventions
- JZP-258, Placebo Oral Solution
- First posted
- 2018-05-22
- Last updated
- 2021-11-24
- Other registries' IDs
- eudract:2018-001311-79
- Results first posted
- 2021-11-24
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 Epworth Sleepiness Scale (ESS) Score | Change from the end of the Stable Dose Period to the end of the Double-blind Randomized Withdrawal Period (DBRW) (2 Weeks) | The ESS is a 8-item self reported questionnaire intended to measure daytime sleepiness. In this test, participants answer questions with regard to the level of sleepiness they experienced over approximately the 7 days prior to the assessment while performing eight common, non-stimulating activities. The ESS total score range is 1 to 24. Each activity is rated on a 4-point scale ranging from a minimum of "would never doze" to a maximum of "a high chance of dozing." Thus, the ESS scale range is as follows: 0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing; 0 indicates a better outcome, and 3 indicates a worse outcome. A positive mean change value indicates an increase in score from the end of the stable dose period and worsened daytime sleepiness. A higher ESS score (above 10) reflects a greater average sleep propensity in daily life (ASP) , or daytime sleepiness. |
| Secondary | Percentage of Participants Reported as Worse on the Patient Global Impression of Change (PGIc) | At the end of the DBRW Period (2 Weeks) | The Patient Global Impression - Change (PGIc) scale was completed by the participant. The PGI-C scale rated the participant's condition at a specified time point on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse." The PGIc scale consists of the following ratings: 1-Very Much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse; a rating of 1 indicates a better outcome, and a rating of 7 indicates a worse outcome. Worsened condition was defined as a PGIc rating of 5, 6, or 7. |
| Secondary | Change in Total Score on the Idiopathic Hypersomnia Severity Scale (IHSS) | Change from the end of the Stable Dose Period to the end of the DBRW Period (2 Weeks) | The IHSS is a 14-item self-reported questionnaire assessing the severity of IH symptoms of excessive sleepiness, prolonged sleep duration, cognitive impairment and sleep inertia. Total scores can range from 0 to 50, with higher scores indicating a greater severity or frequency of symptoms. |
| Secondary | Percentage of Participants Reported as Worse on the Clinical Global Impression of Change (CGIc) | At the end of the DBRW Period (2 Weeks) | The CGIc scale is a 7-point Likert-type scale that rates the Investigator's impression of any change in the severity of the participant's condition at a specified time point. The participant was rated on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse." The CGIc scale consists of the following ratings: 1-Very Much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse; a rating of 1 indicates a better outcome, and a rating of 7 indicates a worse outcome. Worsened condition was defined as a CGIc rating of 5, 6, or 7. |
| Secondary | Change in Total Score on the Functional Outcomes of Sleep Questionnaire (FOSQ-10) | Change from the end of the Stable Dose Period to the end of the DBRW Period (2 Weeks) | The FOSQ-10 is a short version of the original FOSQ-30 instrument, which is a disease specific quality of life questionnaire to determine functional status in adults. Measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these activities are improved by effective treatment. The questionnaire has a 4-point Likert response format (e.g., 1= extreme difficulty, 2= moderate difficulty, 3=a little difficulty, and 4 =no difficulty). FOSQ-10 total score is calculated by first taking the mean of the items for each subscale with more than 1 item completed and then taking the mean across the non-missing 5 subscales (General Productivity, Activity Level, Vigilance, Social Outcomes, Intimacy and Sexual Relationship) multiplied by 5. The score ranges from a minimum of 5 points to a maximum of 20 points, with higher scores indicating better functional status. |
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 Epworth Sleepiness Scale (ESS) Score | Change from the end of the Stable Dose Period to the end of the Double-blind Randomized Withdrawal Period (DBRW) (2 Weeks) | The Modified Intent to Treat (mITT) analysis set included all participants who were randomized to JZP258 or placebo, who received at least 1 dose of study drug during the DBRW and have had at least one set of post randomization assessments for ESS or IHSS, or a PGIc value at the end of the DBRW. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants Reported as Worse on the Patient Global Impression of Change (PGIc) | At the end of the DBRW Period (2 Weeks) | The Modified Intent to Treat (mITT) analysis set included all participants who were randomized to JZP258 or placebo, who received at least 1 dose of study drug during the DBRW and have had at least one set of post randomization assessments for ESS or IHSS, or a PGIc value at the end of the DBRW. | participants | NUMBER |
| SECONDARY | Change in Total Score on the Idiopathic Hypersomnia Severity Scale (IHSS) | Change from the end of the Stable Dose Period to the end of the DBRW Period (2 Weeks) | The Modified Intent to Treat (mITT) analysis set included all participants who were randomized to JZP258 or placebo, who received at least 1 dose of study drug during the DBRW and have had at least one set of post randomization assessments for ESS or IHSS, or a PGIc value at the end of the DBRW. | score on a scale | MEDIAN |
| SECONDARY | Percentage of Participants Reported as Worse on the Clinical Global Impression of Change (CGIc) | At the end of the DBRW Period (2 Weeks) | The Modified Intent to Treat (mITT) analysis set included all participants who were randomized to JZP258 or placebo, who received at least 1 dose of study drug during the DBRW and have had at least one set of post randomization assessments for ESS or IHSS, or a PGIc value at the end of the DBRW. | participants | NUMBER |
| SECONDARY | Change in Total Score on the Functional Outcomes of Sleep Questionnaire (FOSQ-10) | Change from the end of the Stable Dose Period to the end of the DBRW Period (2 Weeks) | The Modified Intent to Treat (mITT) analysis set included all participants who were randomized to JZP258 or placebo, who received at least 1 dose of study drug during the DBRW and have had at least one set of post randomization assessments for ESS or IHSS, or a PGIc value at the end of the DBRW. JZP-258 overall number was 54 and placebo group overall number was 56 as fewer participants were available for this particular assessment. | score on a scale | MEDIAN |
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 Epworth Sleepiness Scale (ESS) Score | JZP-258 | 0.7 | Standard Deviation 3.22 | score on a scale | |
| Change in Epworth Sleepiness Scale (ESS) Score | Placebo | 7.4 | Standard Deviation 5.16 | score on a scale | |
| Percentage of Participants Reported as Worse on the Patient Global Impression of Change (PGIc) | JZP-258 | 12 | participants | ||
| Percentage of Participants Reported as Worse on the Patient Global Impression of Change (PGIc) | Placebo | 52 | participants | ||
| Change in Total Score on the Idiopathic Hypersomnia Severity Scale (IHSS) | JZP-258 | 0.0 | Full Range -8 to 24 | score on a scale | |
| Change in Total Score on the Idiopathic Hypersomnia Severity Scale (IHSS) | Placebo | 14.0 | Full Range -2 to 38 | score on a scale | |
| Percentage of Participants Reported as Worse on the Clinical Global Impression of Change (CGIc) | JZP-258 | 12 | participants | ||
| Percentage of Participants Reported as Worse on the Clinical Global Impression of Change (CGIc) | Placebo | 52 | participants | ||
| Change in Total Score on the Functional Outcomes of Sleep Questionnaire (FOSQ-10) | JZP-258 | -0.08 | Full Range -8.5 to 4.5 | score on a scale | |
| Change in Total Score on the Functional Outcomes of Sleep Questionnaire (FOSQ-10) | Placebo | -4.17 | Full Range -12.5 to 1.3 | score on a scale |
Source ClinicalTrials.gov
Participant flow34
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall | STARTED | On Baseline IH Medication | 88 | |
| Overall | STARTED | Treatment Naive | 66 | |
| Overall | COMPLETED | On Baseline IH Medication | 57 | |
| Overall | COMPLETED | Treatment Naive | 38 | |
| Overall | NOT COMPLETED | On Baseline IH Medication | 31 | |
| Overall | NOT COMPLETED | Treatment Naive | 28 | |
| Open Label Titration and Optimization | STARTED | On Baseline IH Medication | 88 | |
| Open Label Titration and Optimization | STARTED | Treatment Naive | 66 | |
| Open Label Titration and Optimization | COMPLETED | On Baseline IH Medication | 72 | |
| Open Label Titration and Optimization | COMPLETED | Treatment Naive | 53 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 participant flowAdverse events116
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 | Diarrhoea | Gastrointestinal disorders | On Baseline IH Medication | 11 | 88 | 15 |
| other | Diarrhoea | Gastrointestinal disorders | Treatment Naive | 3 | 66 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | JZP-058 | 12 | 154 | 17 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 59 | 2 |
| other | Dry mouth | Gastrointestinal disorders | On Baseline IH Medication | 8 | 88 | 8 |
| other | Dry mouth | Gastrointestinal disorders | Treatment Naive | 2 | 66 | 2 |
| other | Dry mouth | Gastrointestinal disorders | JZP-058 | 10 | 154 | 10 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 0 | 59 | 0 |
| other | Nausea | Gastrointestinal disorders | On Baseline IH Medication | 21 | 88 | 31 |
| other | Nausea | Gastrointestinal disorders | Treatment Naive | 13 | 66 | 14 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | On Baseline IH Medication | 0 | 88 |
| Total, all-cause mortality | Treatment Naive | 0 | 66 |
| Total, all-cause mortality | JZP-058 | 0 | 154 |
| Total, all-cause mortality | Placebo | 0 | 59 |
| Total, other adverse events | On Baseline IH Medication | 64 | 88 |
| Total, other adverse events | Treatment Naive | 39 | 66 |
| Total, other adverse events | JZP-058 | 97 | 154 |
| Total, other adverse events | Placebo | 10 | 59 |
| Total, serious adverse events | On Baseline IH Medication | 2 | 88 |
| Total, serious adverse events | Treatment Naive | 2 | 66 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
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-258 vs Placebo: Percentage of Participants Reported as Worse on the Patient Global Impression of Change (PGIc) | Trial comparisons |
| JZP-258 vs Placebo: Percentage of Participants Reported as Worse on the Clinical Global Impression of Change (CGIc) | 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/NCT03533114
GET https://conductscience.org/api/trials/v1/NCT03533114/flow?page=2