Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU
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)
1 other identifier
interventional
62
7 countries
50
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2013
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 25, 2013
CompletedFirst Posted
Study publicly available on registry
December 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
November 27, 2018
CompletedOctober 10, 2019
October 1, 2019
1.7 years
November 25, 2013
September 25, 2018
October 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Time to First Seizure Following Treatment (TFSFT)
6 hours
Study Arms (2)
USL261
EXPERIMENTAL5 mg intranasal midazolam
Placebo
PLACEBO COMPARATORintranasal placebo
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Unknown Facility
Phoenix, Arizona, United States
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Tucson, Arizona, United States
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La Jolla, California, United States
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Orange, California, United States
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San Francisco, California, United States
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Denver, Colorado, United States
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Englewood, Colorado, United States
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New Haven, Connecticut, United States
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Tampa, Florida, United States
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Augusta, Georgia, United States
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Chicago, Illinois, United States
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Winfield, Illinois, United States
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Wichita, Kansas, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Grand Rapids, Michigan, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Lebanon, New Hampshire, United States
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Edison, New Jersey, United States
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Brooklyn, New York, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Temple, Texas, United States
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Madison, Wisconsin, United States
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Melbourne, Victoria, Australia
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Linz, Austria
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Brussels, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Brno, Czechia
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Prague, Czechia
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Bonn, Germany
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Kork, Germany
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Tübingen, Germany
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Vilnius, Lithuania
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Barcelona, Spain
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Madrid, Spain
Unknown Facility
Valencia, Spain
Related Publications (1)
Spencer DC, Sinha SR, Choi EJ, Cleveland JM, King A, Meng TC, Pullman WE, Sequeira DJ, Van Ess PJ, Wheless JW. Safety and efficacy of midazolam nasal spray for the treatment of intermittent bouts of increased seizure activity in the epilepsy monitoring unit: A double-blind, randomized, placebo-controlled trial. Epilepsia. 2020 Nov;61(11):2415-2425. doi: 10.1111/epi.16704. Epub 2020 Nov 2.
PMID: 33140403DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Sequeira,
- Organization
- Proximagen, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2013
First Posted
December 3, 2013
Study Start
November 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
October 10, 2019
Results First Posted
November 27, 2018
Record last verified: 2019-10