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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma S.P.R.L.; Upsher-Smith Laboratories

Criteria

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