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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
62
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
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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La Jolla, California, United States
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Orange, California, United States
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San Francisco, California, United States
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Denver, Colorado, United States
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Englewood, Colorado, United States
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New Haven, Connecticut, United States
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Tampa, Florida, United States
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Augusta, Georgia, United States
...and 41 more locations