Comparison · NCT03030599-c89176ed
JZP-258 vs Placebo: Number of Participants With Worsening Clinical Global Impression of Change (CGIc) for Narcolepsy Overall
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: Number of Participants With Worsening Clinical Global Impression of Change (CGIc) for Narcolepsy Overall. Trial comparisons, record NCT03030599-c89176ed. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03030599-c89176ed
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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 | 0.0588 | 0.0231 | 0.142 | wilson | |
| Risk in group 2 | 0.6 | 0.479 | 0.71 | wilson | |
| Risk difference, group 1 minus group 2 | -0.541 | -0.657 | -0.394 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.098 | 0.0371 | 0.259 | log | |
| Odds ratio, group 1 over group 2 | 0.0417 | 0.0135 | 0.128 | log | |
| Number needed to treat, for one fewer participant with the outcome on JZP-258 than on Placebo | 1.85 | 1.52 | 2.54 | 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 | JZP-258 at the dose taken during the last 2 weeks of the Stable Dose Period. | 4 | 68 | OG000 |
| Group 2 | Placebo | A matching oral solution to JZP-258. | 39 | 65 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Worsening Clinical Global Impression of Change (CGIc) for Narcolepsy Overall
- Description
At the end of the Double Blind Randomized Withdrawal Period, Investigators rated their impression of any change in the severity of the participant's narcolepsy overall condition since the start of the Double Blind Randomized Withdrawal Period on a 7-point scale ranging from 1 = very much improved to 7 = very much worse. This endpoint measures the percentage of participants with worsening CGIc scores for narcolepsy overall, defined as scores of Much Worse or Very Much Worse.
- Time frame
- At the end of the Double Blind Randomized Withdrawal Period
- Population
- The efficacy population contains all randomized subjects who received at least one dose of double-blind study drug and had at least one set of post-randomization efficacy data.
Source ClinicalTrials.gov
Trial
- Title
- A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy
- NCT number
- NCT03030599
- Phases
- PHASE3
- Conditions
- Narcolepsy With Cataplexy
- Interventions
- JZP-258, Placebo
- Lead sponsor
- Jazz Pharmaceuticals
- Results first posted
- 2020-11-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03030599?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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