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

Stopped early · Phase 3

Conditions studied: Epilepsy

In brief

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

Key facts

Study ID

NCT01529034

Run by

UCB Biopharma S.P.R.L.

People needed

175

Starts

2012-07-01

Last updated by the study team

2023-01-20

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• United States, Arizona — Scottsdale, Arizona, United States
• United States, Arizona — Tucson, Arizona, United States
• United States, Arkansas — Little Rock, Arkansas, United States
• United States, California — Fresno, California, United States
• United States, California — Sacramento, California, United States
• United States, California — Ventura, California, United States
• United States, Colorado — Aurora, Colorado, United States
• United States, Connecticut — New Haven, Connecticut, United States
• United States, Florida — Port Charlotte, Florida, United States
• United States, Florida — Wellington, Florida, United States
• United States, Idaho — Boise, Idaho, United States
• United States, Illinois — Chicago, Illinois, United States
• United States, Kentucky — Lexington, Kentucky, United States
• United States, Maryland — Baltimore, Maryland, United States
• United States, Michigan — Detroit, Michigan, United States
• United States, Minnesota — Saint Paul, Minnesota, United States
• United States, Missouri — St Louis, Missouri, United States
• United States, New Hampshire — Lebanon, New Hampshire, United States
• United States, New Jersey — Hackensack, New Jersey, United States
• United States, New York — New York, New York, United States
• United States, New York — Stony Brook, New York, United States
• United States, New York — The Bronx, New York, United States
• United States, North Carolina — Durham, North Carolina, United States
• United States, North Carolina — Winston-Salem, North Carolina, United States
• United States, Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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