The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Fresno, California, United States
Unnamed facility
Ventura, California, United States
Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation
Number of Participants with Death, Serious Adverse Events, Treatment emergent adverse events (TEAEs) leading to subject discontinuation from study
Time frame: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment Success
Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after study drug administration. Due to early termination of the study, this data was not analyzed.
Time frame: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
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Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Port Charlotte, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Boise, Idaho, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Lexington, Kentucky, United States
Unnamed facility
Saint Paul, Minnesota, United States
...and 6 more locations