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NCT Number: NCT03021018

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ep0087 108, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brivaracetam

Drug
  • Pharmaceutical Form: Solution for infusion
  • Concentration: 10 mg/ml
  • Route of Administration: intravenous

Other names: Briviact

Lorazepam

Drug
  • Pharmaceutical Form: Solution for injection
  • Route of Administration: intravenous

Primary outcomes

  1. 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. 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 outcomes

  1. 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. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

UCB Biopharma S.P.R.L.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2017
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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