A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting



Status:Completed
Conditions:Neurology, Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 70
Updated:8/12/2018
Start Date:February 6, 2017
End Date:April 27, 2018

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A Multicenter, Open-Label, Randomized, Parallel-Group, Active-Controlled Study to Assess the Efficacy and Safety of Brivaracetam Administered Intravenously as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting

The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV)
compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy
Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.


Inclusion Criteria:

- Subject is male or female, 18 to 70 years of age, inclusive

- 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 previously participated in this study and was treated with study drug.
Re-screen is permitted

- 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) or Levetiracetam (LEV) 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
We found this trial at
14
sites
Birmingham, Alabama 35294
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Birmingham, AL
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Belmont, Massachusetts 02478
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Belmont, MA
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Boston, Massachusetts 02215
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Boston, MA
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Charlotte, North Carolina 28204
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Charlotte, NC
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Chicago, Illinois 60611
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Chicago, IL
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Chicago, Illinois 60612
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Chicago, IL
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Detroit, Michigan 48201
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Detroit, MI
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Hershey, Pennsylvania 17033
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Hershey, PA
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Lebanon, New Hampshire 03756
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Lebanon, NH
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Orlando, Florida 32806
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Orlando, FL
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Rochester, New York 14642
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Rochester, NY
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Tucson, Arizona 85724
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Tucson, AZ
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Wichita, Kansas 67214
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Wichita, KS
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