An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects with Seizure Clusters
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Last updated:1st Mar 2012
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.
|Study start date||2012-03-01|