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Termination of study due to low enrollment. There were no safety issues.
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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivaracetam | Experimental | 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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| Phenytoin | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivaracetam intravenous solution | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3 | Lexington | Kentucky | United States | |||
| 1 |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brivaracetam | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Brivaracetam oral tablets | Drug |
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| Phenytoin intravenous solution | Drug |
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| Phenytoin oral tablets | Drug |
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| 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. | 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. | 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 | 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. | From start of first acute iv administration |
| Jackson |
| Mississippi |
| United States |
| FG001 | Phenytoin | 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. |
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| NOT COMPLETED |
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Demographics of the only subject included are presented below.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brivaracetam | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This variable was not analyzed and no results are available. | Posted | 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) |
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| Secondary | 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. | This variable was not analyzed and no results are available. | Posted | 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) |
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| Secondary | 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. | This variable was not analyzed and no results are available. | Posted | From start of first acute iv administration on Day 1 |
| |||||||||||||||||||||||
| Secondary | 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. | This variable was not analyzed and no results are available. | Posted | 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) |
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| Secondary | Percentage of Subjects Requiring a Second Acute Intravenous (iv) Administration Between 15 Minutes to 12 Hours After First Acute iv Administration | This variable was not analyzed and no results are available. | Posted | Between 15 minutes to 12 hours after first acute iv administration |
| ||||||||||||||||||||||||
| Secondary | 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. | This variable was not analyzed and no results are available. | Posted | From start of first acute iv administration |
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Adverse Events were collected during the 75 days the only subject was included in this study.
Adverse Events of the only subject included are presented below.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brivaracetam | 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. | 0 | 1 | 1 | 1 | ||
| EG001 | Phenytoin | 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. | 0 | 0 | 0 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Decreased urinary output | Investigations | MedDRA | Non-systematic Assessment |
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| iv infiltration | General disorders | MedDRA | Non-systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB (Study Director) | UCB Clinical Trial Call Center | +1 887 822 9493 |
| ID | Term |
|---|---|
| C482793 | brivaracetam |
| D010672 | Phenytoin |
| ID | Term |
|---|---|
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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