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

Phase 3

Completed

• Conditions: Epilepsy
• Interventions: Drug: Placebo; Drug: USL261

• Registration Number: NCT01999777
• Lead Sponsor: UCB Biopharma S.P.R.L.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-11-25
• Study First Posted: 2013-12-03
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Disposition First Submitted: 2016-06-15
• Disposition First Submitted QC: 2016-06-15
• Disposition First Posted: 2016-06-17
• Results First Submitted: 2018-09-25
• Results First Submitted QC: 2018-10-30
• Results First Posted: 2018-11-27
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	intranasal placebo
USL261	USL261	5 mg intranasal midazolam

Primary Outcome Measures

Name	Time	Method
Number of Participants That Were Seizure-free	6 hours	A participant was considered "seizure-free" if he or she completed the 6-hour Treatment Phase without seizures recorded, premature discontinuation of study drug, rescue intervention for acute central respiratory depression adverse event (AE), and alterations to background anti-epileptic drug (AED) therapy. Otherwise, the participant was included in the analysis for seizure-free events with the outcome of "seizure."

Secondary Outcome Measures

Name	Time	Method
Time to First Seizure Following Treatment (TFSFT)	6 hours	Time to first seizure following treatment was defined as time from treatment with study drug to the onset of the next seizure, rescue intervention (for acute central respiratory depression AE) to maintain subject safety, alterations to background AED therapy, early termination, or 6 hours, whichever came first.