search
Back to results

A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brivaracetam
Lorazepam
Sponsored by
UCB Biopharma S.P.R.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Brivaracetam, Epilepsy Monitoring Unit, Increased seizure activity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Subject has a known allergic reaction or intolerance to benzodiazepines or benzodiazepine excipients

Sites / Locations

  • Ep0087 108
  • Ep0087 117
  • Ep0087 112
  • Ep0087 115
  • Ep0087 113
  • Ep0087 119
  • Ep0087 116
  • Ep0087 106
  • Ep0087 107
  • Ep0087 125
  • Ep0087 120
  • Ep0087 121
  • Ep0087 105
  • Ep0087 123

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Brivaracetam (BRV) 100 mg

Brivaracetam (BRV) 200 mg

Lorazepam (LZP)

Arm Description

Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period

Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period

Lorazepam 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration
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.
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.
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.
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.

Full Information

First Posted
January 11, 2017
Last Updated
November 26, 2020
Sponsor
UCB Biopharma S.P.R.L.
search

1. Study Identification

Unique Protocol Identification Number
NCT03021018
Brief Title
A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 6, 2017 (Actual)
Primary Completion Date
April 27, 2018 (Actual)
Study Completion Date
April 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma S.P.R.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Brivaracetam, Epilepsy Monitoring Unit, Increased seizure activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brivaracetam (BRV) 100 mg
Arm Type
Experimental
Arm Description
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period
Arm Title
Brivaracetam (BRV) 200 mg
Arm Type
Experimental
Arm Description
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period
Arm Title
Lorazepam (LZP)
Arm Type
Active Comparator
Arm Description
Lorazepam 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.
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Other Intervention Name(s)
Briviact
Intervention Description
Pharmaceutical Form: Solution for infusion Concentration: 10 mg/ml Route of Administration: intravenous
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Intervention Description
Pharmaceutical Form: Solution for injection Route of Administration: intravenous
Primary Outcome Measure Information:
Title
Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication
Description
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)
Secondary Outcome Measure Information:
Title
Time to Next Seizure (Per Clinical Observation) or Rescue Medication
Description
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)
Title
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration
Description
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
Title
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration
Description
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
Title
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration
Description
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
Title
Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration
Description
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
Title
Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration
Description
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
Title
Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Subject has a known allergic reaction or intolerance to benzodiazepines or benzodiazepine excipients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
UCB (+1 844 599 2273)
Official's Role
Study Director
Facility Information:
Facility Name
Ep0087 108
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Ep0087 117
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Ep0087 112
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Ep0087 115
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Ep0087 113
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Ep0087 119
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Ep0087 116
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Ep0087 106
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Ep0087 107
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Ep0087 125
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Ep0087 120
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Ep0087 121
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Ep0087 105
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Ep0087 123
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-2360
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
http://www.clinicalstudydatarequest.com
Links:
URL
http://www.briviact.com/briviact-PI.pdf?v=1479491757
Description
Product Information
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting

We'll reach out to this number within 24 hrs