This site is intended for healthcare professionals
  • Home
  • /
  • Clinical trials
  • /
  • Uncategorised Disease
  • /
  • An Open-Label Safety Study of USL261 in the Outpat...
Clinical trial

An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects with Seizure Clusters

Read time: 1 mins
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.
Category Value
Study start date 2012-03-01

View full details