Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU
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|ClinicalTrials.gov Identifier: NCT01999777|
Recruitment Status : Completed
First Posted : December 3, 2013
Results First Posted : November 27, 2018
Last Update Posted : October 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: USL261 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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)|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
5 mg intranasal midazolam
Placebo Comparator: Placebo
- Number of Participants That Were Seizure-free [ Time Frame: 6 hours ]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 to First Seizure Following Treatment (TFSFT) [ Time Frame: 6 hours ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999777