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Trial record 15 of 107 for:    PHENYTOIN

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
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Type Interventional
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
Hide Arm/Group Description

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
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
Demographics of the only subject included are presented below.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
18  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title 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
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
This variable was not analyzed and no results are available.
Arm/Group Title Brivaracetam Phenytoin
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title 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
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
This variable was not analyzed and no results are available.
Arm/Group Title Brivaracetam Phenytoin
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the First Acute Intravenous (iv) Administration
Hide Description Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.
Time Frame From start of first acute iv administration on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
This variable was not analyzed and no results are available.
Arm/Group Title Brivaracetam Phenytoin
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title 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
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
This variable was not analyzed and no results are available.
Arm/Group Title Brivaracetam Phenytoin
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percentage of Subjects Requiring a Second Acute Intravenous (iv) Administration Between 15 Minutes to 12 Hours After First Acute iv Administration
Hide Description [Not Specified]
Time Frame Between 15 minutes to 12 hours after first acute iv administration
Hide Outcome Measure Data
Hide Analysis Population Description
This variable was not analyzed and no results are available.
Arm/Group Title Brivaracetam Phenytoin
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Time to First Onset of Seizure Cessation Relative to the Start of the First Acute Intravenous (iv) Administration
Hide Description Seizure cessation is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.
Time Frame From start of first acute iv administration
Hide Outcome Measure Data
Hide Analysis Population Description
This variable was not analyzed and no results are available.
Arm/Group Title Brivaracetam Phenytoin
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse Events were collected during the 75 days the only subject was included in this study.
Adverse Event Reporting Description Adverse Events of the only subject included are presented below.
 
Arm/Group Title Brivaracetam Phenytoin
Hide Arm/Group Description

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.

All-Cause Mortality
Brivaracetam Phenytoin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Brivaracetam Phenytoin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Brivaracetam Phenytoin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      0/0    
Gastrointestinal disorders     
Constipation * 1  1/1 (100.00%)  1 0/0  0
General disorders     
iv infiltration * 1  1/1 (100.00%)  1 0/0  0
Investigations     
Decreased urinary output * 1  1/1 (100.00%)  1 0/0  0
Metabolism and nutrition disorders     
Decreased appetite * 1  1/1 (100.00%)  1 0/0  0
Failure to thrive * 1  1/1 (100.00%)  1 0/0  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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     History of Changes
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