Clinical trial NCT03021018: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Epilepsy
Brivaracetam
Epilepsy Monitoring Unit
Increased seizure activity
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-01-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication
timeFrame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)
Secondary outcomes:
measure: Time to Next Seizure (Per Clinical Observation) or Rescue Medication
timeFrame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)
measure: Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration
timeFrame: At 6 hours after the end of study drug administration
measure: Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration
timeFrame: At 8 hours after the end of study drug administration
measure: Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration
timeFrame: At 12 hours after the end of study drug administration
measure: Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration
timeFrame: During the 6 hours after the end of study drug administration
measure: Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration
timeFrame: During the 8 hours after the end of study drug administration
measure: Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration
timeFrame: During the 12 hours after the end of study drug administration
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Ep0087 108
state: Alabama
city: Tucson
country: United States
facility: Ep0087 117
state: Arizona
city: Orlando
country: United States
facility: Ep0087 112
state: Florida
city: Chicago
country: United States
facility: Ep0087 115
state: Illinois
city: Chicago
country: United States
facility: Ep0087 113
state: Illinois
city: Wichita
country: United States
facility: Ep0087 119
state: Kansas
city: Belmont
country: United States
facility: Ep0087 116
state: Massachusetts
city: Boston
country: United States
facility: Ep0087 106
state: Massachusetts
city: Detroit
country: United States
facility: Ep0087 107
state: Michigan
city: Lebanon
country: United States
facility: Ep0087 125
state: New Hampshire
city: Rochester
country: United States
facility: Ep0087 120
state: New York
city: Chapel Hill
country: United States
facility: Ep0087 121
state: North Carolina
city: Charlotte
country: United States
facility: Ep0087 105
state: North Carolina
city: Hershey
country: United States
facility: Ep0087 123
state: Pennsylvania
Study officials:
affiliation: UCB (+1 844 599 2273)
name: UCB Cares
role: STUDY_DIRECTOR
References: