Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU
NCT ID: NCT01999777
Last Updated: 2019-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
62 participants
INTERVENTIONAL
2013-11-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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USL261
5 mg intranasal midazolam
USL261
Placebo
intranasal placebo
Placebo
Interventions
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USL261
Placebo
Eligibility Criteria
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Inclusion Criteria
* Subject body weight is ≥ 40 kg to ≤ 125 kg (inclusive)
* Subject has an established diagnosis of partial or generalized epilepsy
Exclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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UCB Biopharma S.P.R.L.
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
Tucson, Arizona, United States
La Jolla, California, United States
Orange, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Englewood, Colorado, United States
New Haven, Connecticut, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Winfield, Illinois, United States
Wichita, Kansas, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
Lebanon, New Hampshire, United States
Edison, New Jersey, United States
Brooklyn, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Madison, Wisconsin, United States
Melbourne, Victoria, Australia
Linz, , Austria
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Brno, , Czechia
Prague, , Czechia
Bonn, , Germany
Kork, , Germany
Tübingen, , Germany
Vilnius, , Lithuania
Barcelona, , Spain
Madrid, , Spain
Valencia, , Spain
Countries
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References
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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.
Other Identifiers
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USL261-301
Identifier Type: -
Identifier Source: org_study_id
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