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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
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Brivaracetam Drug: Lorazepam Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 6, 2017
Actual Primary Completion Date : April 27, 2018
Actual Study Completion Date : April 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: Brivaracetam (BRV) 100 mg
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period
Drug: Brivaracetam
  • Pharmaceutical Form: Solution for infusion
  • Concentration: 10 mg/ml
  • Route of Administration: intravenous
Other Name: Briviact

Experimental: Brivaracetam (BRV) 200 mg
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period
Drug: Brivaracetam
  • Pharmaceutical Form: Solution for infusion
  • Concentration: 10 mg/ml
  • Route of Administration: intravenous
Other Name: Briviact

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




Primary Outcome Measures :
  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 is calculated in hours.


Secondary Outcome Measures :
  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 is calculated in hours.

  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 ]
    This variable is 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.

  3. 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 ]
    This variable is 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.

  4. 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 ]
    This variable is 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.

  5. 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 ]
    This variable is 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.

  6. 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 ]
    This variable is 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.

  7. 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 ]
    This variable is 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021018


Locations
United States, Alabama
Ep0087 108
Birmingham, Alabama, United States, 35294
United States, Arizona
Ep0087 117
Tucson, Arizona, United States, 85724
United States, Florida
Ep0087 112
Orlando, Florida, United States, 32806
United States, Illinois
Ep0087 115
Chicago, Illinois, United States, 60611
Ep0087 113
Chicago, Illinois, United States, 60612
United States, Kansas
Ep0087 119
Wichita, Kansas, United States, 67214
United States, Massachusetts
Ep0087 116
Belmont, Massachusetts, United States, 02478
Ep0087 106
Boston, Massachusetts, United States, 02215
United States, Michigan
Ep0087 107
Detroit, Michigan, United States, 48201
United States, New Hampshire
Ep0087 125
Lebanon, New Hampshire, United States, 03756
United States, New York
Ep0087 120
Rochester, New York, United States, 14642
United States, North Carolina
Ep0087 121
Chapel Hill, North Carolina, United States, 27599
Ep0087 105
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
Ep0087 123
Hershey, Pennsylvania, United States, 17033-2360
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Study Director: UCB Cares UCB (+1 844 599 2273)

Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03021018     History of Changes
Other Study ID Numbers: EP0087
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Epilepsy
Brivaracetam
Epilepsy Monitoring Unit
Increased seizure activity

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Brivaracetam
Lorazepam
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action