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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
* Active Substance: Brivaracetam * Pharmaceutical Form: Solution for infusion * Concentration: 10 mg/mL * Route of Administration: Intravenous bolus use
* 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
* Active Substance: Phenytoin * Pharmaceutical Form: Solution for infusion * Concentration: 50 mg/mL * Route of Administration: Intravenous use
3
Lexington, Kentucky, United States
1
Jackson, Mississippi, United States
Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts 1 Hour After the End of the Last Acute iv Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing
Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.
Time frame: From 1 hour after end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)
Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts After the End of the Last Acute Intravenous (iv) Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing
Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.
Time frame: From end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)
Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the First Acute Intravenous (iv) Administration
Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.
Time frame: From start of first acute iv administration on Day 1
Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the Last Acute Intravenous (iv) Administration That Occurred Prior to the Initiation of Bid (Twice a Day) Dosing
Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.
Time frame: From start of last acute iv administration prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)
Percentage of Subjects Requiring a Second Acute Intravenous (iv) Administration Between 15 Minutes to 12 Hours After First Acute iv Administration
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* Active Substance: Phenytoin * Pharmaceutical Form: Tablet * Concentration: Weight based * Route of Administration: Oral use
Time frame: Between 15 minutes to 12 hours after first acute iv administration
Time to First Onset of Seizure Cessation Relative to the Start of the First Acute Intravenous (iv) Administration
Seizure cessation is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.
Time frame: From start of first acute iv administration