Conditions: Nonconvulsive Electrographic Seizures
Keywords: Brivaracetam Phenytoin Nonconvulsive electrographic seizures
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1
Healthy volunteers: no

Brief summary:
The primary objective of this study is to compare the efficacy of Brivaracetam and Phenytoin, both administered intravenously, in adult subjects experiencing nonconvulsive electrographic seizures.

Detailed description:

Arms:
arm 1: Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.

Subjects should transition to oral medication as soon as they are able to swallow tablets. arm 2: Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.

Subjects should transition to oral medication as soon as they are able to swallow tablets.

Interventions: intervention 1: Brivaracetam intravenous solution intervention 2: Brivaracetam oral tablets intervention 3: Phenytoin intravenous solution intervention 4: Phenytoin oral tablets
Intervention descriptions: intervention 1: * Active Substance: Brivaracetam
* Pharmaceutical Form: Solution for infusion
* Concentration: 10 mg/mL
* Route of Administration: Intravenous bolus use intervention 2: * Active Substance: Brivaracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 10 mg and 25 mg tablets; Daily Dose: 200 mg/day (100 mg bid)
* Route of Administration: Oral use intervention 3: * Active Substance: Phenytoin
* Pharmaceutical Form: Solution for infusion
* Concentration: 50 mg/mL
* Route of Administration: Intravenous use intervention 4: * Active Substance: Phenytoin
* Pharmaceutical Form: Tablet
* Concentration: Weight based
* Route of Administration: Oral use

Protocol document: