Comparison · NCT01390220-c3e7fd3b
USL261 CP vs Placebo CP: Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP)
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. USL261 CP vs Placebo CP: Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP). Trial comparisons, record NCT01390220-c3e7fd3b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01390220-c3e7fd3b
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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 | 0.537 | 0.453 | 0.62 | wilson | |
| Risk in group 2 | 0.343 | 0.241 | 0.463 | wilson | |
| Risk difference, group 1 minus group 2 | 0.194 | 0.0479 | 0.325 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.57 | 1.08 | 2.26 | log | |
| Odds ratio, group 1 over group 2 | 2.22 | 1.21 | 4.08 | log | |
| Number needed to treat, for one more participant with the outcome on USL261 CP than on Placebo CP | 5.15 | 3.07 | 20.9 | 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 | USL261 CP | 5 mg intranasal midazolam~USL261 | 72 | 134 | OG000 |
| Group 2 | Placebo CP | Intranasal placebo~Placebo | 23 | 67 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP)
- Description
Treatment Success is defined as achieving both of the following: 1) termination of seizure(s) within 10 minutes after double-blind study drug administration, and 2) no recurrence of seizure(s) beginning 10 minutes after study drug administration to 6 hours after study drug administration. Participants who received the open-label second dose within 6 hours of administration of the double-blind dose were analyzed as having had a seizure.
- Time frame
- 6 hours
- Population
- Randomized participants who received the double-blind dose in the CP.
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters
- NCT number
- NCT01390220
- Phases
- PHASE3
- Conditions
- Epilepsy
- Interventions
- USL261, Placebo
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Results first posted
- 2019-05-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01390220?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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