Comparison · NCT03533114-0b586fe8
JZP-258 vs Placebo: Percentage of Participants Reported as Worse on the Patient Global Impression of Change (PGIc)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. JZP-258 vs Placebo: Percentage of Participants Reported as Worse on the Patient Global Impression of Change (PGIc). Trial comparisons, record NCT03533114-0b586fe8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03533114-0b586fe8
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.214 | 0.127 | 0.338 | wilson | |
| Risk in group 2 | 0.881 | 0.775 | 0.941 | wilson | |
| Risk difference, group 1 minus group 2 | -0.667 | -0.773 | -0.504 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.243 | 0.146 | 0.405 | log | |
| Odds ratio, group 1 over group 2 | 0.0367 | 0.0133 | 0.101 | log | |
| Number needed to treat, for one fewer participant with the outcome on JZP-258 than on Placebo | 1.5 | 1.29 | 1.99 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | JZP-258 | Participants randomized to JZP-258 will receive the dosing regimen taken during the Stable Dose Period. | 12 | 56 | OG000 |
| Group 2 | Placebo | Participants randomized to placebo will receive an oral solution equivalent to the dosing regimen of JZP-258 taken during the Stable Dose Period. | 52 | 59 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Participants Reported as Worse on the Patient Global Impression of Change (PGIc)
- Description
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.
- Time frame
- At the end of the DBRW Period (2 Weeks)
- Population
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.
Source ClinicalTrials.gov
Trial
- 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
- Phases
- PHASE3
- Conditions
- Idiopathic Hypersomnia
- Interventions
- JZP-258, Placebo Oral Solution
- Lead sponsor
- Jazz Pharmaceuticals
- Results first posted
- 2021-11-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03533114?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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