Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures
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ClinicalTrials.gov Identifier: NCT02088957 |
Recruitment Status :
Terminated
(Termination of study due to low enrollment. There were no safety issues.)
First Posted : March 17, 2014
Results First Posted : April 13, 2016
Last Update Posted : July 11, 2018
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Nonconvulsive Electrographic Seizures |
Interventions |
Drug: Brivaracetam intravenous solution Drug: Brivaracetam oral tablets Drug: Phenytoin intravenous solution Drug: Phenytoin oral tablets |
Enrollment | 1 |
Recruitment Details | Sixty subjects were planned to be screened in order to enroll 50 subjects in a 1:1 ratio to intravenous (iv) Brivaracetam (BRV) or iv Phenytoin (PHT) with stratification based on categorized age (<65 years versus ≥65 years) across approximately 15 sites. |
Pre-assignment Details | This study was stopped due to low enrollment; the termination date was 17 Nov 2014. One subject enrolled, but discontinued from the study prematurely due to lack of efficacy. |
Arm/Group Title | Brivaracetam | Phenytoin |
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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. |
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. |
Period Title: Overall Study | ||
Started | 1 | 0 |
Completed | 0 | 0 |
Not Completed | 1 | 0 |
Reason Not Completed | ||
Lack of Efficacy | 1 | 0 |
Arm/Group Title | Brivaracetam | |
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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. |
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Overall Number of Baseline Participants | 1 | |
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Demographics of the only subject included are presented below.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
1 100.0%
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>=65 years |
0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 1 participants | |
18 (0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1 participants | |
Female |
1 100.0%
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Male |
0 0.0%
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Name/Title: | UCB (Study Director) |
Organization: | UCB Clinical Trial Call Center |
Phone: | +1 887 822 9493 |
Responsible Party: | UCB Pharma ( UCB BIOSCIENCES, Inc. ) |
ClinicalTrials.gov Identifier: | NCT02088957 |
Other Study ID Numbers: |
N01394 |
First Submitted: | February 20, 2014 |
First Posted: | March 17, 2014 |
Results First Submitted: | March 14, 2016 |
Results First Posted: | April 13, 2016 |
Last Update Posted: | July 11, 2018 |