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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01999777




Registration number
NCT01999777
Ethics application status
Date submitted
25/11/2013
Date registered
3/12/2013
Date last updated
10/10/2019

Titles & IDs
Public title
Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU
Scientific 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)
Secondary ID [1] 0 0
USL261-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - USL261
Treatment: Drugs - Placebo

Experimental: USL261 - 5 mg intranasal midazolam

Placebo Comparator: Placebo - intranasal placebo


Treatment: Drugs: USL261


Treatment: Drugs: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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."
Timepoint [1] 0 0
6 hours
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 hours

Eligibility
Key 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
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
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United States of America
State/province [6] 0 0
Georgia
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United States of America
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Illinois
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United States of America
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Kansas
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United States of America
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Louisiana
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Mississippi
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United States of America
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Missouri
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United States of America
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New Hampshire
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United States of America
State/province [15] 0 0
New Jersey
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United States of America
State/province [16] 0 0
New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
Country [20] 0 0
United States of America
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Oregon
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United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
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Tennessee
Country [23] 0 0
United States of America
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Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Austria
State/province [25] 0 0
Linz
Country [26] 0 0
Belgium
State/province [26] 0 0
Brussels
Country [27] 0 0
Belgium
State/province [27] 0 0
Gent
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Czechia
State/province [29] 0 0
Brno
Country [30] 0 0
Czechia
State/province [30] 0 0
Prague
Country [31] 0 0
Germany
State/province [31] 0 0
Bonn
Country [32] 0 0
Germany
State/province [32] 0 0
Kork
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Germany
State/province [33] 0 0
Tübingen
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Lithuania
State/province [34] 0 0
Vilnius
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Spain
State/province [35] 0 0
Barcelona
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Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Biopharma S.P.R.L.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01999777
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications