A Phase 3 interventional study of USL261 and Placebo in Epilepsy, sponsored by UCB Biopharma S.P.R.L.. Completed at 51 sites in 8 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2019-10-10.
Sponsored by UCB Biopharma S.P.R.L. (part of UCB S.A.) · Phase 3, Interventional, and Treatment
This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased seizure activity.
1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.
This study's enrollment of 62 is above the median of 50 across 1,228 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →UCB Biopharma S.P.R.L. is the lead sponsor of 48 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.
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Exclusion Criteria:
5 mg intranasal midazolam
Drug: USL261
intranasal placebo
Drug: Placebo
Number of Participants That Were Seizure-free
A participant was considered "seizure-free" if he or she completed the 6-hour Treatment Phase without seizures recorded, premature discontinuation of study drug, rescue intervention for acute central respiratory depression adverse event (AE), and alterations to background anti-epileptic drug (AED) therapy. Otherwise, the participant was included in the analysis for seizure-free events with the outcome of "seizure."
Time frame: 6 hours
Time to First Seizure Following Treatment (TFSFT)
Time to first seizure following treatment was defined as time from treatment with study drug to the onset of the next seizure, rescue intervention (for acute central respiratory depression AE) to maintain subject safety, alterations to background AED therapy, early termination, or 6 hours, whichever came first.
Time frame: 6 hours
| Milestone | USL261 | Placebo |
|---|---|---|
| Started | 31 | 31 |
| Completed | 31 | 31 |
| Not completed | 0 | 0 |
A participant was considered "seizure-free" if he or she completed the 6-hour Treatment Phase without seizures recorded, premature discontinuation of study drug, rescue intervention for acute central respiratory depression adverse event (AE), and alterations to background anti-epileptic drug (AED) therapy. Otherwise, the participant was included in the analysis for seizure-free events with the outcome of "seizure."
| Participants | USL261 | Placebo |
|---|---|---|
| Number of Participants That Were Seizure-free | 17 | 12 |
Time to first seizure following treatment was defined as time from treatment with study drug to the onset of the next seizure, rescue intervention (for acute central respiratory depression AE) to maintain subject safety, alterations to background AED therapy, early termination, or 6 hours, whichever came first.
| hours | USL261 | Placebo |
|---|---|---|
| Time to First Seizure Following Treatment (TFSFT) | NA (4.0 to NA) | 3.9 (1.8 to NA) |
Collected over From informed consent until up to 48 hours of completion of the Treatment Phase. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| USL261 | 0/31 (0%) | 0/31 (0%) | 16/31 (51.6%) |
| Placebo | 0/31 (0%) | 0/31 (0%) | 17/31 (54.8%) |
| Event | USL261 | Placebo |
|---|---|---|
| Product taste abnormalGeneral disorders | 2/31 | 6/31 |
| HeadacheNervous system disorders | 1/31 | 5/31 |
| Nasal discomfortRespiratory, thoracic and mediastinal disorders | 5/31 | 5/31 |
| NauseaGastrointestinal disorders | 3/31 | 1/31 |
| Throat irritationRespiratory, thoracic and mediastinal disorders | 3/31 | 3/31 |
| RhinitisInfections and infestations | 0/31 | 2/31 |
| Tongue injuryInjury, poisoning and procedural complications | 0/31 | 2/31 |
| SomnolenceNervous system disorders | 2/31 | 0/31 |
The Baseline Characteristics refers to the Safety Analysis Set which included all subjects who took at least 1 dose of study drug.
| Age, Categorical(Participants) | USL261 | Placebo | Total |
|---|---|---|---|
| <=18 years | 2 | 2 | 4 |
| Between 18 and 65 years | 29 | 29 | 58 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | USL261 | Placebo | Total |
|---|---|---|---|
| Mean | 32.7 ± 12.94 | 35.9 ± 13.56 | 34.3 ± 13.24 |
| Sex: Female, Male(Participants) | USL261 | Placebo | Total |
|---|---|---|---|
| Female | 18 | 21 | 39 |
| Male | 13 | 10 | 23 |
| Ethnicity (NIH/OMB)(Participants) | USL261 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 28 | 29 | 57 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | USL261 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 26 | 27 | 53 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(participants) | USL261 | Placebo | Total |
|---|---|---|---|
| Belgium | 1 | 0 | 1 |
| United States | 22 | 22 | 44 |
| Czechia | 2 | 2 | 4 |
| Lithuania | 3 | 2 | 5 |
| Germany | 0 | 1 | 1 |
| Spain | 3 | 4 | 7 |
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Midazolam