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

UCB

Status and phase

Completed

Phase 3

Conditions

Epilepsy

Treatments

Drug: Placebo

Drug: USL261

Study type

Interventional

Funder types

Industry

Identifiers

NCT01999777

USL261-301

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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