Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy

This is a multicenter, open-label, 4-arm, randomized, parallel-group study to evaluate safety and tolerability of Brivaracetam Intravenous (BRV iv) as adjunctive treatment for adults with epilepsy according to an initiation or a conversion scheme, during repeated dosing (100 mg/administration twice daily for 4.5 days).

Eligible subjects will be randomized in a 1:1:1:1 ratio to the 4 treatment arms

Eligibility Criteria:
Inclusion Criteria:

* An Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved written Informed Consent form signed and dated by the subject or by parent(s) or legal representative
* Subjects from 16 to 70 years
* Subjects with a body weight of \>/= 40 kg
* Female subjects without childbearing potential or female subjects with childbearing potential if they use a medically accepted contraceptive method
* Subject/legal representative considered as reliable and capable of adhering to the protocol
* Subjects with well-characterized focal or generalized epilepsy or epileptic syndrome
* Subjects with a history of partial-onset seizures whether or not secondarily generalized or primary generalized seizures
* Subjects being uncontrolled while treated with 1 to 2 permitted concomitant antiepileptic drugs (AEDs)
* Permitted concomitant antiepileptic drugs (AEDs) and vagus nerve stimulation (VNS) being stable and at optimal dosage for the subject from at least 1 month before Visit 1 and expected to be kept stable during the Run-In and Evaluation Periods

Exclusion Criteria:

* Mentally impaired subjects unable to understand the study purpose
* History or presence of status epilepticus during 1 year preceding Visit 1 or Baseline
* Subjects on felbamate with less than 18 months continuous exposure before Visit 1
* Subjects currently on vigabatrin
* Subject taking any drug with possible relevant central nervous system effects except is stable from at least 1 month before Visit 1 and expected to be kept stable during the trial
* Subjects taking any drug that may significantly influence the metabolism of Brivaracetam (BRV) except if the dose has been kept stable at least 1 month before Visit 1, and is expected to be kept stable during the trial
* History of cerebrovascular accident in the last 6 months
* Subjects suffering from severe cardiovascular disease or peripheral vascular disease
* Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
* Any clinical conditions which impair reliable participation in the study or necessitate the use of medication not allowed by protocol
* Presence of a terminal illness
* Presence of a serious infection
* Subjects with a history of sever adverse hematologic reaction to any drug
* Subjects suffering from severe disturbance of hemostasis
* Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT) values of more than 3 times the upper limit of the reference range
* Subjects having clinically significant deviations from reference range values for laboratory parameters: creatinine clearance calculated \< 50 ml / min, platelets \< 100,000 / µL, or neutrophil cells \< 1,800 / µL
* Clinically significant electrocardiogram (ECG) abnormalities according to the Investigator
* History of suicide attempt
* In the Investigator's medical judgment, any current suicidal ideation or other serious psychiatric disorders requiring of having required hospitalization or medication
* Known allergic reaction or intolerance to pyrrolidone derivatives and / or investigational product excipients
* Known multiple drug allergies or severe drug allergy
* Pregnant or lactating women
* Known alcohol or drug addiction or abuse within the last 2 years
* Subject institutionalized under judicial decision
* Problems of venous accessibility
* Subject taking part in another clinical / pharmacological study in the month preceding enrollment (Visit 1)
* Investigators, coinvestigators, their spouses or children, or any study collaborators
* Subjects previously treated with Brivaracetam (BRV)
* Subject previously screened within this study