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



Status:Completed
Conditions:Neurology, Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:12 - Any
Updated:11/29/2018
Start Date:November 2013
End Date:August 2015

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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)

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.


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
We found this trial at
39
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Chapel Hill, NC
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Ann Arbor, MI
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Augusta, GA
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Boston, MA
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Brooklyn, NY
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Chicago, IL
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Columbus, OH
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Dallas, TX
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Denver, CO
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Durham, NC
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Edison, NJ
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Englewood, CO
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Grand Rapids, MI
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Hershey, PA
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Jackson, MS
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La Jolla, CA
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Lebanon, NH
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Madison, WI
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Melbourne,
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Memphis, TN
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New Haven, CT
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New Orleans, LA
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Oklahoma City, OK
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Philadelphia, PA
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Portland, OR
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Rochester, NY
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San Antonio, TX
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Tampa, FL
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Temple, TX
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Tucson, AZ
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Wichita, KS
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Winfield, IL
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2126
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Winston-Salem, NC
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