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

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

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