A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Brivaracetam; Lorazepam
Intervention description: Pharmaceutical Form: Solution for infusion
Concentration: 10 mg/ml
Route of Administration: intravenous; Pharmaceutical Form: Solution for injection
Route of Administration: intravenous
Intervention MeSH terms: Lorazepam; Brivaracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Epilepsy; Brivaracetam; Epilepsy Monitoring Unit; Increased seizure activity

Summary:

      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.
    

Eligibility criteria:

        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) 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