Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Upsher-Smith Laboratories
Information provided by (Responsible Party):
Upsher-Smith Laboratories Identifier:
First received: February 3, 2012
Last updated: August 26, 2015
Last verified: August 2015

February 3, 2012
August 26, 2015
July 2012
March 2016   (final data collection date for primary outcome measure)
Long-term safety and tolerability [ Designated as safety issue: Yes ]
Adverse events, clinical laboratory assessments, sedation, vital signs, physical exams, C-SSRS
Same as current
Complete list of historical versions of study NCT01529034 on Archive Site
Treatment Success [ Designated as safety issue: No ]
Termination of seizure(s) within 10 minutes and no recurrence within 4 hours after study drug administration
Same as current
Not Provided
Not Provided
Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters
An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects With Seizure Clusters
The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.
Not Provided
Phase 3
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Drug: USL261
Experimental: USL261
Intervention: Drug: USL261
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes
  • Has successfully completed study P261-401, and the subject and caregiver have demonstrated adequate compliance with P261-401 study procedures as determined by the investigator

Exclusion Criteria:

  • Has experienced status epilepticus during or since the P261-401 study
  • In the opinion of the investigator, is experiencing an ongoing, uncontrolled, clinically significant adverse event(s) from P261-401 at Visit 1 or did experience a clinically significant adverse event in study P261-401 that might prevent the subject from safely participating in the study
  • Has a neurological disorder that is likely to progress in the next year
  • Has a history of acute narrow-angle glaucoma
  • Has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or gastrointestinal disease that could interfere with the study, subject safety/safety monitoring, or is not stable despite current therapy
  • Subject has severe chronic cardio-respiratory disease or the need for ambulatory oxygen
  • Has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study
  • Has active suicidal plan or intent as determined by the C-SSRS at Visit 1 or medical history
  • Subject has had vagus nerve stimulator (VNS) implanted since the completion of study P261-401
12 Years and older
Contact: Gerrit Ross 1-866-372-0526
United States,   Australia,   Canada,   Germany,   Hungary,   Israel,   Italy,   New Zealand,   Poland,   Spain,   Ukraine
P261-402, 2011-004109-25
Not Provided
Upsher-Smith Laboratories
Upsher-Smith Laboratories
Not Provided
Not Provided
Upsher-Smith Laboratories
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP