A Long-term Safety and Tolerability Study 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

NCT02161185

Run by

UCB Biopharma S.P.R.L.

People needed

7

Starts

2014-05-01

Expected to finish

2015-05-01

Last updated by the study team

2019-10-10

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a competent, adult caregiver(s) who is able to recognize and observe the subject's seizure cluster episodes
• Has an established diagnosis of partial or generalized epilepsy that includes all the following:
• A documented history of seizure clusters lasting a minimum of 10 minutes, seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any)
• A second seizure in the seizure cluster typically occurs within 6 hours from the time of recognition
• A seizure cluster pattern composed of multiple (≥ 2) partial or generalized seizures
• A seizure cluster pattern established >3 months before Visit 1
• A frequency of ≥ 3 stereotyped seizure clusters during the year before Visit 1
• At least 1 stereotyped seizure cluster occuring ≤ 4 months before Visit 1
• Currently on a stable regimen of AED(s) that includes a benzodiazepine
• Weight is 40 kg to 125 kg, inclusive

You may not qualify if…

• Has a neurological disorder that is likely to progress in the next year
• Has a severe chronic cardio-respiratory disease
• Has a psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
• Has a history of their stereotypical seizure cluster progressing to status epilepticus within 2 years before Visit 1
• Has a history of acute narrow-angle glaucoma
• Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Fresno, California, United States
• Study site — Ventura, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Port Charlotte, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Lexington, Kentucky, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Reno, Nevada, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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