Trials / Completed
CompletedNCT01999777
Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU
A Randomized, Double-Blind, Placebo Controlled Trial Examining the Safety and Efficacy of Midazolam Intranasal Spray (USL261) for the Treatment of Intermittent Bouts of Increased Seizure Activity in the Epilepsy Monitoring Unit (EMU)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- UCB Biopharma S.P.R.L. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | USL261 | |
| DRUG | Placebo |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2013-12-03
- Last updated
- 2019-10-10
- Results posted
- 2018-11-27
Locations
51 sites across 8 countries: United States, Australia, Austria, Belgium, Czechia, Germany, Lithuania, Spain
Source: ClinicalTrials.gov record NCT01999777. Inclusion in this directory is not an endorsement.