Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters
NCT ID: NCT01529034
Last Updated: 2023-01-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
175 participants
INTERVENTIONAL
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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USL261
Intranasal midazolam 5 mg
USL261
Interventions
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USL261
Eligibility Criteria
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Inclusion Criteria
* Has successfully completed study P261-401, and the subject and caregiver have demonstrated adequate compliance with P261-401 study procedures as determined by the investigator
Exclusion Criteria
* In the opinion of the investigator, is experiencing an ongoing, uncontrolled, clinically significant adverse event(s) from P261-401 at Visit 1 or did experience a clinically significant adverse event in study P261-401 that might prevent the subject from safely participating in the study
* Has a neurological disorder that is likely to progress in the next year
* Has a history of acute narrow-angle glaucoma
* Has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or gastrointestinal disease that could interfere with the study, subject safety/safety monitoring, or is not stable despite current therapy
* Subject has severe chronic cardio-respiratory disease or the need for ambulatory oxygen
* Has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study
* Has active suicidal plan or intent as determined by the C-SSRS at Visit 1 or medical history
* Subject has had vagus nerve stimulator (VNS) implanted since the completion of study P261-401
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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Israel
Ramat Gan, , Israel
United States, Arizona
Phoenix, Arizona, United States
United States, Arizona
Scottsdale, Arizona, United States
United States, Arizona
Tucson, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Fresno, California, United States
United States, California
Sacramento, California, United States
United States, California
Ventura, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Florida
Port Charlotte, Florida, United States
United States, Florida
Wellington, Florida, United States
United States, Idaho
Boise, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Michigan
Detroit, Michigan, United States
United States, Minnesota
Saint Paul, Minnesota, United States
United States, Missouri
St Louis, Missouri, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New Jersey
Hackensack, New Jersey, United States
United States, New York
New York, New York, United States
United States, New York
Stony Brook, New York, United States
United States, New York
The Bronx, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
United States, Texas
Greenville, Texas, United States
Australia, New South Wales
Randwick, New South Wales, Australia
Australia, Victoria
Heidelberg West, Victoria, Australia
Australia, Victoria
Parkville, Victoria, Australia
Canada
Montreal, Ontario, Canada
Canada, Toronto
Toronto, Ontario, Canada
Canada
Toronto, Quebec, Canada
Germany
München, Bavaria, Germany
Germany
Marberg, Hesse, Germany
Germany
Bonn, North Rhine-Westphalia, Germany
Germany
Bielefeld, Westfalen-Lippe, Germany
Hungary
Budapest, , Hungary
Israel
Haifa, , Israel
Israel
Petah Tikvah, , Israel
New Zealand
Christchurch, Canterbury, New Zealand
Poland
Gdansk, , Poland
Poland
Katowice, , Poland
Poland
Lublin, , Poland
Spain
Seville, Andalusia, Spain
Spain
Girona, Cataluyna, Spain
Spain
Madrid, , Spain
Ukraine
Ivano-Frankivsk, , Ukraine
Ukraine
Kharkiv, , Ukraine
Ukraine
Odesa, , Ukraine
Ukraine
Poltava, , Ukraine
Ukraine
Ternopil, , Ukraine
Ukraine
Vinnytsa, , Ukraine
Countries
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References
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Meng TC, Szaflarski JP, Chen L, Brunnert M, Campos R, Van Ess P, Pullman WE, Fakhoury T. Psychosocial outcomes of repeated treatment of seizure clusters with midazolam nasal spray: Results of a phase 3, open-label extension trial. Epilepsy Behav. 2023 Jan;138:108989. doi: 10.1016/j.yebeh.2022.108989. Epub 2022 Nov 18.
Wheless JW, Meng TC, Van Ess PJ, Detyniecki K, Sequeira DJ, Pullman WE. Safety and efficacy of midazolam nasal spray in the outpatient treatment of patients with seizure clusters: An open-label extension trial. Epilepsia. 2019 Sep;60(9):1809-1819. doi: 10.1111/epi.16300. Epub 2019 Jul 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2011-004109-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P261-402
Identifier Type: -
Identifier Source: org_study_id
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