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

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ClinicalTrials.gov Identifier: NCT03021018
Recruitment Status : Completed
First Posted : January 13, 2017
Results First Posted : May 27, 2019
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Tracking Information
First Submitted Date  ICMJE January 11, 2017
First Posted Date  ICMJE January 13, 2017
Results First Submitted Date  ICMJE April 26, 2019
Results First Posted Date  ICMJE May 27, 2019
Last Update Posted Date May 27, 2019
Actual Study Start Date  ICMJE February 6, 2017
Actual Primary Completion Date April 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication [ Time Frame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2) ]
This variable was calculated in hours.
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2017)
Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication [ Time Frame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2) ]
Change History Complete list of historical versions of study NCT03021018 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • Time to Next Seizure (Per Clinical Observation) or Rescue Medication [ Time Frame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2) ]
    This variable was calculated in hours.
  • Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2017)
  • Time to Next Seizure (Per Clinical Observation) or Rescue Medication [ Time Frame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2) ]
  • Proportion of subjects who are seizure-free per clinical observation at 6 hours after the end of study drug administration [ Time Frame: At 6 hours after the end of study drug administration ]
  • Proportion of subjects who are seizure-free per clinical observation at 8 hours after the end of study drug administration [ Time Frame: At 8 hours after the end of study drug administration ]
  • Proportion of subjects who are seizure-free per clinical observation at 12 hours after the end of study drug administration [ Time Frame: At 12 hours after the end of study drug administration ]
  • Proportion of subjects who receive rescue medication during the 6 hours after the end of study drug administration [ Time Frame: During the 6 hours after the end of study drug administration ]
  • Proportion of subjects who receive rescue medication during the 8 hours after the end of study drug administration [ Time Frame: During the 8 hours after the end of study drug administration ]
  • Proportion of subjects who receive rescue medication during the 12 hours after the end of study drug administration [ Time Frame: During the 12 hours after the end of study drug administration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • Drug: Brivaracetam
    • Pharmaceutical Form: Solution for infusion
    • Concentration: 10 mg/ml
    • Route of Administration: intravenous
    Other Name: Briviact
  • Drug: Lorazepam
    • Pharmaceutical Form: Solution for injection
    • Route of Administration: intravenous
Study Arms  ICMJE
  • Experimental: Brivaracetam (BRV) 100 mg
    Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period
    Intervention: Drug: Brivaracetam
  • Experimental: Brivaracetam (BRV) 200 mg
    Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period
    Intervention: Drug: Brivaracetam
  • Active Comparator: Lorazepam (LZP)
    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: Drug: Lorazepam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2018)
110
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2017)
60
Actual Study Completion Date  ICMJE April 27, 2018
Actual Primary Completion Date April 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) or Levetiracetam (LEV) 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT03021018
Other Study ID Numbers  ICMJE EP0087
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party UCB Pharma ( UCB Biopharma S.P.R.L. )
Study Sponsor  ICMJE UCB Biopharma S.P.R.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares UCB (+1 844 599 2273)
PRS Account UCB Pharma
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP