Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU

Completed · Phase 3 · Has a placebo group

Conditions studied: Epilepsy

In brief

This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased seizure activity.

Key facts

Study ID

NCT01999777

Run by

UCB Biopharma S.P.R.L.

People needed

62

Starts

2013-11-01

Expected to finish

2015-08-01

Last updated by the study team

2019-10-10

Who can join

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

You may qualify if…

• Subject has been admitted to the institution's EMU for seizure characterization or pre-surgical evaluation, or such admission is planned within 28 days
• Subject body weight is ≥ 40 kg to ≤ 125 kg (inclusive)
• Subject has an established diagnosis of partial or generalized epilepsy

You may not qualify if…

• Subject has history of status epilepticus in the 6 months prior to Screening
• Subject has a progressive neurological disorder such as brain tumor, demyelinating disease, or degenerative central nervous system (CNS) disease that is likely to progress in the next 12 months
• Subject has respiratory failure (or is at risk for respiratory failure) or other severe cardiorespiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen
• Subject has acute narrow-angle glaucoma
• Subject is receiving chronic benzodiazepine treatment (defined as an average of ≥ 4 administrations per week) and cannot safely withdraw from such treatment within the washout period prior to treatment

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — Orange, California, United States
• Study site — San Francisco, California, United States
• Study site — Denver, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Tampa, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Winfield, Illinois, United States
• Study site — Wichita, Kansas, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Jackson, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Edison, New Jersey, United States
• Study site — Brooklyn, New York, United States
• Study site — Rochester, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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