Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV)

Inclusion Criteria:

- Subject with well-characterized Epilepsy according to the 1989 International League
Against Epilepsy (ILAE) classification

- Subject with Epilepsy who the investigator expects will benefit from Levetiracetam
(LEV) but for whom the investigator has decided to discontinue due to nonpsychotic
behavioral side effects following the introduction of LEV

- Subject is currently receiving LEV at the recommended therapeutic dose (dose ranging
from 1 g/day to 3 g/day)

- Subject currently treated with minimum 2 and maximum 3 Anti-Epileptic Drugs (AEDs)
including LEV. Vagal Nerve Stimulation (VNS) is allowed and will be counted as a
concomitant AED

- Female subjects without childbearing potential (postmenopausal for at least 2 years,
bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female
subjects with childbearing potential are eligible if they use a medically accepted
contraceptive method

Exclusion Criteria:

- Subject has a lifetime history of suicide attempt (including an actual, interrupted or
aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a
positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide
Severity Rating Scale (C-SSRS) at Visit 1

- Subject whose seizures could not be reliably counted on a regular basis due to their
fast and repetitive occurrence (clusters or flurries)

- Subject has history or presence of status epilepticus during the year preceding Visit
1 or during Baseline

- Subject has history or presence of known psychogenic nonepileptic seizures

- Subject has any clinical conditions (eg, bone marrow depression, chronic hepatic
disease, and/or severe renal impairment) which impair reliable participation in the
study or necessitate the use of medication not allowed by protocol

- Subject is pregnant or lactating