Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures

Inclusion Criteria:

- Subjects ≥16 years. Subjects under 18 years may only be included where legally
permitted and ethically accepted

- Subjects in the neurological intensive care unit (NICU) (or equivalent closely
monitored environment) having brain insult including traumatic brain injury and having
nonconvulsive electrographic seizures (NCES) confirmed by electroencephalogram (EEG),
lasting a minimum of 10 seconds but not >30 minutes (minimum of 1 seizure in the last
6 hours) and treatment with an antiepileptic drug (AED) is required according to the
physician's clinical judgment

- Subject is expected to be under cEEG monitoring with video surveillance in the Neuro
ICU for at least 36 hours from the first administration of study drug

Exclusion Criteria:

- Subject has history of severe adverse hematologic or cutaneous reaction to any drug

- Subject presenting with status epilepticus or nonconvulsive status epilepticus (NCSE)
(ie, 1 continuous, convulsive or nonconvulsive, unremitting seizure lasting >30
minutes during Visit 1)

- Subject has been diagnosed with anoxic brain injury

- Subject has a known history of status epilepticus during the 6 months preceding Visit
1

- Subject is currently treated with Levetiracetam (LEV) or Phenytoin (PHT) or has been
treated within the last 30 days before Visit 1 with LEV or PHT

- Subject is on felbamate with <18 months' exposure before Visit 1

- Subject has presence of any sign (clinical or imaging techniques) suggesting a rapidly
progressing process such that the subject is not expected to survive >48 hours

- Subject has any clinical condition that would impair reliable participation in the
study or necessitate the use of medications not allowed by the protocol