Trial · NCT01390220
Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters
NCT01390220, Phase 3, Terminated, UCB Biopharma S.P.R.L.; results first posted 2019-05-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters. Trials, record NCT01390220. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01390220
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters
- NCT number
- NCT01390220
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 292 participants, actual
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Conditions
- Epilepsy
- Interventions
- USL261, Placebo
- First posted
- 2011-07-08
- Last updated
- 2019-10-10
- Other registries' IDs
- eudract:2011-001318-32
- Results first posted
- 2019-05-31
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP) | 6 hours | 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. |
| Secondary | Participants With Seizure(s) >10 Minutes to 4 Hours After Administration of the Double-blind Dose | 4 hours | Participants with recurrence of seizure(s) \>10 minutes and up to 4 hours after administration of the double-blind dose in the CP. Participants who received the open-label second dose within 4 hours of administration of the double-blind dose were analyzed as having had a seizure. |
| Secondary | Occurrence of Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose | 24 hours | Occurrence of next seizure with a start time \>10 minutes and up to 24 hours after administration of the double-blind dose in the CP. Participants who did not have another seizure before the end of the 24-hour observation period were censored at the end of the observation period. Participants administered the open-label second dose who did not have a seizure were censored at the time of the administration. |
| Secondary | Time to Next Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose | 24 hours | Time to next seizure with a start time \>10 minutes and up to 24 hours after administration of the double-blind dose in the CP. Participants who did not have another seizure before the end of the 24-hour observation period were censored at the end of the observation period. Participants administered the open-label second dose who did not have a seizure were censored at the time of the administration. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP) | 6 hours | Randomized participants who received the double-blind dose in the CP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With Seizure(s) >10 Minutes to 4 Hours After Administration of the Double-blind Dose | 4 hours | Randomized participants who received the double-blind dose in the CP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence of Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose | 24 hours | Randomized participants who received the double-blind dose in the CP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Next Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose | 24 hours | Randomized participants who received the double-blind dose in the CP | Hours | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP) | USL261 CP | 72 | Participants | ||
| Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP) | Placebo CP | 23 | Participants | ||
| Participants With Seizure(s) >10 Minutes to 4 Hours After Administration of the Double-blind Dose | USL261 CP | 51 | Participants | ||
| Participants With Seizure(s) >10 Minutes to 4 Hours After Administration of the Double-blind Dose | Placebo CP | 40 | Participants | ||
| Occurrence of Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose | USL261 CP | 50 | Participants | ||
| Occurrence of Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose | Placebo CP | 31 | Participants | ||
| Time to Next Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose | USL261 CP | NA | 95% Confidence Interval 17.9 to NA | Hours | |
| Time to Next Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose | Placebo CP | 12.1 | 95% Confidence Interval 2.2 to NA | Hours |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Test Dose Phase | STARTED | USL261 TDP | 292 | |
| Test Dose Phase | STARTED | USL261 CP | 0 | |
| Test Dose Phase | STARTED | Placebo CP | 0 | |
| Test Dose Phase | COMPLETED | USL261 TDP | 201 | |
| Test Dose Phase | COMPLETED | USL261 CP | 0 | |
| Test Dose Phase | COMPLETED | Placebo CP | 0 | |
| Test Dose Phase | NOT COMPLETED | USL261 TDP | 91 | |
| Test Dose Phase | NOT COMPLETED | USL261 CP | 0 | |
| Test Dose Phase | NOT COMPLETED | Placebo CP | 0 | |
| Comparative Phase | STARTED | USL261 TDP | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events45
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 | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | USL261 TDP | 47 | 292 | 61 |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | USL261 CP, USL261 5 mg Only | 5 | 91 | 5 |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | USL261 CP, USL261 5 mg + 5 mg | 7 | 43 | 8 |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Placebo CP, Placebo Only | 2 | 26 | 2 |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Placebo CP, Placebo + USL261 5 mg | 3 | 41 | 3 |
| other | Throat irritation | Respiratory, thoracic and mediastinal disorders | USL261 TDP | 15 | 292 | 15 |
| other | Throat irritation | Respiratory, thoracic and mediastinal disorders | USL261 CP, USL261 5 mg Only | 2 | 91 | 2 |
| other | Throat irritation | Respiratory, thoracic and mediastinal disorders | USL261 CP, USL261 5 mg + 5 mg | 3 | 43 | 3 |
| other | Throat irritation | Respiratory, thoracic and mediastinal disorders | Placebo CP, Placebo Only | 0 | 26 | 0 |
| other | Throat irritation | Respiratory, thoracic and mediastinal disorders | Placebo CP, Placebo + USL261 5 mg | 1 | 41 | 1 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | USL261 TDP | 0 | 292 |
| Total, all-cause mortality | USL261 CP, USL261 5 mg Only | 0 | 91 |
| Total, all-cause mortality | USL261 CP, USL261 5 mg + 5 mg | 0 | 43 |
| Total, all-cause mortality | Placebo CP, Placebo Only | 0 | 26 |
| Total, all-cause mortality | Placebo CP, Placebo + USL261 5 mg | 0 | 41 |
| Total, other adverse events | USL261 TDP | 78 | 292 |
| Total, other adverse events | USL261 CP, USL261 5 mg Only | 17 | 91 |
| Total, other adverse events | USL261 CP, USL261 5 mg + 5 mg | 10 | 43 |
| Total, other adverse events | Placebo CP, Placebo Only | 3 | 26 |
| Total, other adverse events | Placebo CP, Placebo + USL261 5 mg | 7 | 41 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| USL261 CP vs Placebo CP: Occurrence of Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose | Trial comparisons |
| USL261 CP vs Placebo CP: Participants With Seizure(s) >10 Minutes to 4 Hours After Administration of the Double-blind Dose | Trial comparisons |
| 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 |
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/NCT01390220
GET https://conductscience.org/api/trials/v1/NCT01390220/events?page=2