Clinical trial
An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects with Seizure Clusters
To evaluate the long-term safety and tolerability of USL-261 in the treatment of seizure clusters using the following:
� Occurrence of respiratory depression after study drug administration (defined as < 8 breaths per minute and/or a sustained decrease in respiratory effort requiring emergency rescue treatment with assisted breathing or intubation).
� AEs
� Clinical laboratory measurements.
� OAA/S Sum Score and Composite Scores at the end of the seizure cluster (within 6 hours after study drug administration).
� Physical, nasal, and neurological examinations.
� Vital sign measurements.
� C-SSRS
� Requirement for ER or EMS visits.
Category | Value |
---|---|
Study start date | 2012-06-14 |