A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
NCT ID: NCT03021018
Last Updated: 2020-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2017-02-06
2018-04-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Brivaracetam (BRV) 100 mg
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period
Brivaracetam
* Pharmaceutical Form: Solution for infusion
* Concentration: 10 mg/ml
* Route of Administration: intravenous
Brivaracetam (BRV) 200 mg
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period
Brivaracetam
* Pharmaceutical Form: Solution for infusion
* Concentration: 10 mg/ml
* Route of Administration: intravenous
Lorazepam (LZP)
Lorazepam bolus is to be injected based on information from the patient leaflet/package insert. The rate of injection should not exceed 2.0 mg/min. The LZP dose will be determined according to the Investigator's clinical judgment.
Lorazepam
* Pharmaceutical Form: Solution for injection
* Route of Administration: intravenous
Interventions
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Brivaracetam
* Pharmaceutical Form: Solution for infusion
* Concentration: 10 mg/ml
* Route of Administration: intravenous
Lorazepam
* Pharmaceutical Form: Solution for injection
* Route of Administration: intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has an established diagnosis of epilepsy
* Subject has been admitted to the institution's Epilepsy Monitoring Unit (EMU) for seizure characterization or noninvasive presurgical evaluation or such admission is planned within 21 days of Screening
Exclusion Criteria
* Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within the previous 30 days of Epilepsy Monitoring Unit (EMU) admission or is currently participating in another study of an IMP or a medical device
* Subject has taken brivaracetam (BRV) in the 21 days prior to EMU admission
* History or presence of status epilepticus during the 6 months prior to EMU admission
* Subject has a medical or psychiatric condition that in the opinion of the Investigator could jeopardize or would compromise the subject's ability to participate in this study
* Subject has \> 2x upper limit of normal (ULN) of any of the following: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or \> ULN total bilirubin
* Subject has chronic liver disease
* Subject has hypersensitivity to BRV or any of its excipients
* Subject has a history of alcohol or drug abuse during the 6 months prior to EMU admission
* Subject with a history of psychogenic seizures
* Subject is a pregnant or lactating female
* Subject has a history of a significant Adverse Event (AE) due to a benzodiazepine in the opinion of the Investigator
* Subject has respiratory failure (or is at risk for respiratory failure), untreated sleep apnea, 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 or myasthenia gravis
* Subject is receiving benzodiazepine treatment (defined as an average of \>=4 administrations per week) that started less than 28 days prior to EMU admission
* Subject has a known allergic reaction or intolerance to benzodiazepines or benzodiazepine excipients
18 Years
70 Years
ALL
No
Sponsors
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UCB Biopharma S.P.R.L.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
UCB (+1 844 599 2273)
Locations
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Ep0087 108
Birmingham, Alabama, United States
Ep0087 117
Tucson, Arizona, United States
Ep0087 112
Orlando, Florida, United States
Ep0087 115
Chicago, Illinois, United States
Ep0087 113
Chicago, Illinois, United States
Ep0087 119
Wichita, Kansas, United States
Ep0087 116
Belmont, Massachusetts, United States
Ep0087 106
Boston, Massachusetts, United States
Ep0087 107
Detroit, Michigan, United States
Ep0087 125
Lebanon, New Hampshire, United States
Ep0087 120
Rochester, New York, United States
Ep0087 121
Chapel Hill, North Carolina, United States
Ep0087 105
Charlotte, North Carolina, United States
Ep0087 123
Hershey, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Product Information
FDA Safety Alerts and Recalls
Other Identifiers
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EP0087
Identifier Type: -
Identifier Source: org_study_id