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

Epilepsy Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo Controlled Trial Examining the Safety and Efficacy of Midazolam Intranasal Spray (USL261) for the Treatment of Intermittent Bouts of Increased Seizure Activity in the Epilepsy Monitoring Unit (EMU)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999777
• Other study ID #: USL261-301
• Status: Completed
• Phase: Phase 3
• Start date: November 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2019
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• USL261

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Czechia,  Germany,  Lithuania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants That Were Seizure-free	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."	6 hours
Secondary	Time to First Seizure Following Treatment (TFSFT)	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.	6 hours