The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV) compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
* Pharmaceutical Form: Solution for infusion * Concentration: 10 mg/ml * Route of Administration: intravenous
* Pharmaceutical Form: Solution for injection * Route of Administration: intravenous
Ep0087 108
Birmingham, Alabama, United States
Ep0087 117
Tucson, Arizona, United States
Ep0087 112
Orlando, Florida, United States
Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication
This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed with electroencephalogram \[EEG\] confirmation) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.
Time frame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)
Time to Next Seizure (Per Clinical Observation) or Rescue Medication
This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed and not necessarily confirmed via electroencephalogram \[EEG\]) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.
Time frame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration
This variable was defined as the number of subjects seizure free during 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat (ITT) set multiplied by 100.
Time frame: At 6 hours after the end of study drug administration
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration
This variable was defined as the number of subjects seizure free during 8 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.
Time frame: At 8 hours after the end of study drug administration
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration
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Ep0087 115
Chicago, Illinois, United States
Ep0087 113
Chicago, Illinois, United States
Ep0087 119
Wichita, Kansas, United States
Ep0087 116
Belmont, Massachusetts, United States
Ep0087 106
Boston, Massachusetts, United States
Ep0087 107
Detroit, Michigan, United States
Ep0087 125
Lebanon, New Hampshire, United States
...and 4 more locations
This variable was defined as the number of subjects seizure free during 12 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.
Time frame: At 12 hours after the end of study drug administration
Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration
This variable was defined as the number of subjects who received rescue medication with start date and time within the first 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat as randomized (ITT-R) set multiplied by 100.
Time frame: During the 6 hours after the end of study drug administration
Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration
This variable was defined as the number of subjects who received rescue medication with start date and time within the first 8 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.
Time frame: During the 8 hours after the end of study drug administration
Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration
This variable was defined as the number of subjects who received rescue medication with start date and time within the first 12 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.
Time frame: During the 12 hours after the end of study drug administration