A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
A Multicenter, Open-Label, Randomized, Parallel-Group, Active-Controlled Study to Assess the Efficacy and Safety of Brivaracetam Administered Intravenously as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
1 other identifier
interventional
46
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2017
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2017
CompletedFirst Posted
Study publicly available on registry
January 13, 2017
CompletedStudy Start
First participant enrolled
February 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2018
CompletedResults Posted
Study results publicly available
May 28, 2019
CompletedDecember 16, 2020
November 1, 2020
1.2 years
January 11, 2017
April 26, 2019
November 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)
Secondary Outcomes (7)
Time to Next Seizure (Per Clinical Observation) or Rescue Medication
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
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
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
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
During the 6 hours after the end of study drug administration
- +2 more secondary outcomes
Study Arms (3)
Brivaracetam (BRV) 100 mg
EXPERIMENTALTwo 5 ml vials of brivaracetam administered intravenously over a 2-minute period
Brivaracetam (BRV) 200 mg
EXPERIMENTALFour 5 ml vials of brivaracetam administered intravenously over a 4-minute period
Lorazepam (LZP)
ACTIVE COMPARATORLorazepam bolus is to be injected based on information from the patient leaflet/package insert. The rate of injection should not exceed 2.0 mg/min. The LZP dose will be determined according to the Investigator's clinical judgment.
Interventions
* Pharmaceutical Form: Solution for infusion * Concentration: 10 mg/ml * Route of Administration: intravenous
* Pharmaceutical Form: Solution for injection * Route of Administration: intravenous
Eligibility Criteria
You may qualify if:
- Subject is male or female, 18 to 70 years of age, inclusive
- Subject has an established diagnosis of epilepsy
- Subject has been admitted to the institution's Epilepsy Monitoring Unit (EMU) for seizure characterization or noninvasive presurgical evaluation or such admission is planned within 21 days of Screening
You may not qualify if:
- Subject has previously participated in this study and was treated with study drug. Re-screen is permitted
- Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within the previous 30 days of Epilepsy Monitoring Unit (EMU) admission or is currently participating in another study of an IMP or a medical device
- Subject has taken brivaracetam (BRV) in the 21 days prior to EMU admission
- History or presence of status epilepticus during the 6 months prior to EMU admission
- Subject has a medical or psychiatric condition that in the opinion of the Investigator could jeopardize or would compromise the subject's ability to participate in this study
- Subject has \> 2x upper limit of normal (ULN) of any of the following: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or \> ULN total bilirubin
- Subject has chronic liver disease
- Subject has hypersensitivity to BRV or any of its excipients
- Subject has a history of alcohol or drug abuse during the 6 months prior to EMU admission
- Subject with a history of psychogenic seizures
- Subject is a pregnant or lactating female
- Subject has a history of a significant Adverse Event (AE) due to a benzodiazepine in the opinion of the Investigator
- Subject has respiratory failure (or is at risk for respiratory failure), untreated sleep apnea, or other severe cardiorespiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen
- Subject has acute narrow-angle glaucoma or myasthenia gravis
- Subject is receiving benzodiazepine treatment (defined as an average of \>=4 administrations per week) that started less than 28 days prior to EMU admission
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Ep0087 108
Birmingham, Alabama, 35294, United States
Ep0087 117
Tucson, Arizona, 85724, United States
Ep0087 112
Orlando, Florida, 32806, United States
Ep0087 115
Chicago, Illinois, 60611, United States
Ep0087 113
Chicago, Illinois, 60612, United States
Ep0087 119
Wichita, Kansas, 67214, United States
Ep0087 116
Belmont, Massachusetts, 02478, United States
Ep0087 106
Boston, Massachusetts, 02215, United States
Ep0087 107
Detroit, Michigan, 48201, United States
Ep0087 125
Lebanon, New Hampshire, 03756, United States
Ep0087 120
Rochester, New York, 14642, United States
Ep0087 121
Chapel Hill, North Carolina, 27599, United States
Ep0087 105
Charlotte, North Carolina, 28204, United States
Ep0087 123
Hershey, Pennsylvania, 17033-2360, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
UCB (+1 844 599 2273)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 11, 2017
First Posted
January 13, 2017
Study Start
February 6, 2017
Primary Completion
April 27, 2018
Study Completion
April 27, 2018
Last Updated
December 16, 2020
Results First Posted
May 28, 2019
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.