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

Description

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.

Study Start Date

February, 06 2017

Estimated Completion Date

April 2018

Interventions

  • Drug: Lorazepam
  • Drug: Brivaracetam

Study ID

UCB Pharma -- EP0087

Status

Recruiting

Trial ID

NCT03021018

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

60

Sponsor

UCB Pharma

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

Gender

All

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (67)

Study Location Distance Name Phone Email
Ep0087 106 - Boston, Massachusetts 2.4 miles None None None
Ep0087 106 - Boston, Massachusetts 2.4 miles None None None
Ep0087 106 - Boston, Massachusetts 2.4 miles None None None
Ep0087 106 - Boston, Massachusetts 2.4 miles None None None
Ep0087 106 - Boston, Massachusetts 2.4 miles None None None
Ep0087 103 - Boston, Massachusetts 3.2 miles None None None
Ep0087 103 - Boston, Massachusetts 3.2 miles None None None
Ep0087 103 - Boston, Massachusetts 3.2 miles None None None
Ep0087 103 - Boston, Massachusetts 3.2 miles None None None
Ep0087 103 - Boston, Massachusetts 3.2 miles None None None
Ep0087 116 - Belmont, Massachusetts 4.7 miles None None None
Ep0087 116 - Belmont, Massachusetts 4.7 miles None None None
Ep0087 116 - Belmont, Massachusetts 4.7 miles None None None
Ep0087 116 - Belmont, Massachusetts 4.7 miles None None None
Ep0087 116 - Belmont, Massachusetts 4.7 miles None None None
Ep0087 125 - Lebanon, New Hampshire 105.5 miles None None None
Ep0087 101 - Lebanon, New Hampshire 105.5 miles None None None
Ep0087 101 - Lebanon, New Hampshire 105.5 miles None None None
Ep0087 125 - Lebanon, New Hampshire 105.5 miles None None None
Ep0087 101 - Lebanon, New Hampshire 105.5 miles None None None
Ep0087 125 - Lebanon, New Hampshire 105.5 miles None None None
Ep0087 125 - Lebanon, New Hampshire 105.5 miles None None None
Ep0087 125 - Lebanon, New Hampshire 105.5 miles None None None
Ep0087 101 - Lebanon, New Hampshire 105.5 miles None None None
Ep0087 101 - Lebanon, New Hampshire 105.5 miles None None None
Ep0087 110 - New Haven, Connecticut 119.2 miles None None None
Ep0087 120 - Rochester, New York 335.8 miles None None None
Ep0087 120 - Rochester, New York 335.8 miles None None None
Ep0087 120 - Rochester, New York 335.8 miles None None None
Ep0087 120 - Rochester, New York 335.8 miles None None None
Ep0087 120 - Rochester, New York 335.8 miles None None None
Ep0087 111 - Durham, North Carolina 608.4 miles None None None
Ep0087 111 - Durham, North Carolina 608.4 miles None None None
Ep0087 111 - Durham, North Carolina 608.4 miles None None None
Ep0087 111 - Durham, North Carolina 608.4 miles None None None
Ep0087 111 - Durham, North Carolina 608.4 miles None None None
Ep0087 107 - Detroit, Michigan 611.5 miles None None None
Ep0087 107 - Detroit, Michigan 611.5 miles None None None
Ep0087 107 - Detroit, Michigan 611.5 miles None None None
Ep0087 107 - Detroit, Michigan 611.5 miles None None None
Ep0087 107 - Detroit, Michigan 611.5 miles None None None
Ep0087 121 - Chapel Hill, North Carolina 616.4 miles None None None
Ep0087 121 - Chapel Hill, North Carolina 616.4 miles None None None
Ep0087 121 - Chapel Hill, North Carolina 616.4 miles None None None
Ep0087 121 - Chapel Hill, North Carolina 616.4 miles None None None
Ep0087 121 - Chapel Hill, North Carolina 616.4 miles None None None
Ep0087 105 - Charlotte, North Carolina 720.9 miles None None None
Ep0087 105 - Charlotte, North Carolina 720.9 miles None None None
Ep0087 105 - Charlotte, North Carolina 720.9 miles None None None
Ep0087 105 - Charlotte, North Carolina 720.9 miles None None None
Ep0087 105 - Charlotte, North Carolina 720.9 miles None None None
Ep0087 115 - Chicago, Illinois 847.9 miles None None None
Ep0087 122 - Chicago, Illinois 848.0 miles None None None
Ep0087 122 - Chicago, Illinois 848.0 miles None None None
Ep0087 122 - Chicago, Illinois 848.0 miles None None None
Ep0087 113 - Chicago, Illinois 851.3 miles None None None
Ep0087 113 - Chicago, Illinois 851.3 miles None None None
Ep0087 113 - Chicago, Illinois 851.3 miles None None None
Ep0087 108 - Birmingham, Alabama 1,052.1 miles None None None
Ep0087 112 - Orlando, Florida 1,118.6 miles None None None
Ep0087 119 - Wichita, Kansas 1,421.3 miles None None None
Ep0087 119 - Wichita, Kansas 1,421.3 miles None None None
Ep0087 119 - Wichita, Kansas 1,421.3 miles None None None
Ep0087 119 - Wichita, Kansas 1,421.3 miles None None None
Ep0087 119 - Wichita, Kansas 1,421.3 miles None None None
Ep0087 117 - Tucson, Arizona 2,281.0 miles None None None
Ep0087 104 - Phoenix, Arizona 2,297.3 miles None None None

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